Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use 91083273-04 CAUTION: Federal law restricts this device to sale, Content: 92162683 REV A distribution and use by or on the order of a physician. Precision™ Spinal Cord Stimulator System Clinician Manual Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders. Clinician Manual 91083273-04 ii of iv Table of Contents Manual Overview ...........................................................................................................................1 Device and Product Description ..................................................................................................2 Implantable Pulse Generator ...........................................................................................................2 Leads ...............................................................................................................................................2 Lead Extension ................................................................................................................................2 Lead Splitter ......................................................................................................................................3 Indications for Use ........................................................................................................................4 Precision System Clinical Summary ................................................................................................4 Contraindications ..........................................................................................................................8 Safety Information ..........................................................................................................................9 Instructions for the Patient ................................................................................................................9 Warnings ..........................................................................................................................................9 Precautions ......................................................................................................................................9 Adverse Effects ..............................................................................................................................11 Instructions for the Physician .........................................................................................................11 Package Contents .......................................................................................................................13 IPG Kit ...........................................................................................................................................13 Percutaneous Permanent Lead Kit ................................................................................................13 Percutaneous Trial Lead Kit ............................................................................................................13 Lead Extension Kit .........................................................................................................................13 2x4 Splitter Kit .................................................................................................................................14 Surgical Paddle Lead Kit ...............................................................................................................14 Infinion 16 Lead Kit .........................................................................................................................14 Infinion 16 Trial Lead Kit .................................................................................................................14 Infinion CX Lead Kit ........................................................................................................................15 Infinion CX Lead Trial Lead Kit .......................................................................................................15 Splitter 2x8 Kit .................................................................................................................................15 Infinion 16 Trial Configuration Kit ....................................................................................................15 Infinion 16 Configuration Kit ............................................................................................................15 Sterilization, Handling, and Storage ..........................................................................................16 Sterilization ....................................................................................................................................16 IPG Handling and Storage .............................................................................................................16 Lead, Lead Extension, and Splitter Handling and Storage .............................................................17 Pre-Op Instructions .....................................................................................................................18 Percutaneous Lead Placement in the Epidural Space .............................................................19 Infinion CX Lead Placement in the Epidural Space with Entrada™ Needle ...................................20 Lead Connection to Splitter ............................................................................................................24 Surgical Paddle Lead Placement in the Epidural Space ..........................................................27 Connecting the OR Cable Assembly .........................................................................................28 Intraoperative Stimulation Testing .............................................................................................29 Securing the Trial Lead ...............................................................................................................30 Securing the Infinion CX Trial Lead ...........................................................................................31 Permanent Lead Anchoring and Tunneling ...............................................................................32 Anchoring the Lead ........................................................................................................................33 Tunneling the Lead or Lead Extension ..........................................................................................34 Clinician Manual 91083273-04 iii of iv Precision™ Spinal Cord Stimulator System Clinician Manual Connecting the Lead Extension .....................................................................................................36 Connecting to the Trial Stimulator .............................................................................................38 Removal of Trial Leads, Extensions, and Splitters ...................................................................39 Option A: Percutaneous Lead Removal after Temporary Trial .......................................................39 Option B: Lead Extension Removal after Permanent Trial ............................................................39 Option C: Splitter Removal after Trial .............................................................................................39 IPG Implantation ..........................................................................................................................40 Connecting to the IPG .................................................................................................................41 For Percutaneous Lead - Dual Lead Connection ..........................................................................41 For Infinion™ 16 Lead Connection .................................................................................................41 For Infinion CX Lead Connection ....................................................................................................41 For Percutaneous Lead - Single Lead Connection ........................................................................41 For Surgical Paddle Lead Connection ...........................................................................................41 Programming with the Infinion 16 Lead and Infinion CX Lead ........................................................43 IPG Explant or Replacement ......................................................................................................44 Rechargeable Stimulator System ..............................................................................................45 IPG Battery Status .........................................................................................................................45 Charging Steps ..............................................................................................................................46 Patient Remote Control ..................................................................................................................47 Device Linking ...............................................................................................................................52 Searching .......................................................................................................................................53