Infinion™ 16 SC-2316-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 08714729797821), received between Dec 6, 2016 and Sep 17, 2026 — classified as 124 injuries, 25 malfunctions.

The most frequently reported specific device problem is “High impedance” (88 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had lead pull.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797888 ↗
• InjuryJul 6, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO HIGH LEAD IMPEDANCES. IN ADDITION, THE PATIENT ELECTED TO PROCEED WITH REPLACEMENT IN ORDER TO OBTAIN MRI CONDITIONALITY. POSTOPERATIVELY, THE PATIENT IS STABLE AND REPORTS NO COMPLICATIONS. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF BY THE PHYSICIAN AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721879 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673601 ↗
• InjuryJun 16, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) TRIAL, WHICH INITIALLY PROVIDED THERAPEUTIC BENEFIT FOR THE UNDERLYING CONDITION. HOWEVER, THE PATIENTS PREEXISTING LOWER BACK PAIN, DESCRIBED AS CONSTANT AND OF MODERATE TO SEVERE INTENSITY, TEMPORARILY WORSENED DURING THE TRIAL PERIOD. THE PATIENT DENIED ANY RECENT TRAUMA. ACCORDING TO THE PHYSICIANS ASSESSMENT, THE WORSENING OF SYMPTOMS WAS ATTRIBUTED TO A FLARE OF CHRONIC PAIN AND WAS DETERMINED NOT TO BE RELATED TO THE DEVICE OR THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AND RECEIVED MEDICAL MANAGEMENT, INCLUDING PHARMACOLOGIC TREATMENT AND A KETAMINE INFUSION. THE SCS TRIAL HAS SINCE CONCLUDED AND WAS CONSIDERED SUCCESSFUL. AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED BUT WAS NOTED TO BE DOING WELL. THE TRIAL LEADS WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Discomfort; Pain

  MAUDE report 25519718 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO HAVE THEIR SPINAL CORD STIMULATION (SCS) TRIAL LEADS EXPLANTED AT THE END OF THE TRIAL. THE PATIENT EXPERIENCED A LOT OF DISCOMFORT OVER THE LAST THREE DAYS AT THE INSERTION POINT IN HIS BACK. THE PATIENT ALSO APPEARED TO BE FEBRILE WITH A TEMPERATURE OF 37.5 DEGREES CELSIUS. THE PHYSICIAN FOUND SOME PUS AROUND ONE LEAD AT THE INSERTION SITE OF A TRIAL SCS LEAD DURING THE PROCEDURE. THE PHYSICIAN DECIDED TO SEND THE PATIENT TO THE EMERGENCY DEPARTMENT WHERE THE PATIENT WAS HOSPITALIZED FOR AN INFECTION. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Bacterial Infection; Discomfort; Fever; Fluid Discharge; Pain

  MAUDE report 25366954 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION (SCS) TRIAL LEAD TEST PERIOD, THE PATIENT EXHIBITED REDNESS WITH AN ALLERGIC REACTION TO THE IMPLANTED LEADS. THE PATIENT UNDERWENT AN EARLY TRIAL LEAD PULL DUE TO THE REACTION. THE PATIENT HAS SINCE RECOVERED AND NO LONGER HAS SYMPTOMS. THE TRIAL LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 22473687 ↗
• InjuryJun 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT THE PROCEDURE DUE TO HIGH IMPEDANCE IN THE LEADS AND SPLITTER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR LEADS AND SPLITTER WERE EXPLANTED AND REPLACED. THE DEVICES WERE RETAINED PER FACILITY POLICY AND WILL NOT BE RETURN FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191032 ↗
• InjuryJun 3, 2025Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A TRIAL PROCEDURE DURING WHICH LEAD PLACEMENT WAS ATTEMPTED. THE FIRST LEAD INSERTION ON THE LEFT SIDE WAS SUCCESSFUL. HOWEVER, DURING THE SECOND LEAD INSERTION ON THE RIGHT SIDE, THE LEAD TIP EMERGED FROM THE PUNCTURE NEEDLE BUT THE LEAD TRAJECTORY TURNED TOWARD THE VENTRAL SIDE. WHEN THE LEAD WAS PULLED OUT, THE LEAD TIP CAME INTO CONTACT WITH THE LEFT PUNCTURE NEEDLE TIP WHICH RESULTED IN ONE CONTACT OF THE LEAD BECOMING SHEARED OFF AND REMAINED IN THE FIRST VERTEBRA OF THE LUMBAR SPINE. THERE WAS NO REPORTED PATIENT INJURY AND THE LEAD TIP REMAINS IN THE PATIENTS BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22135766 ↗
• InjuryJun 3, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT FOLLOWING A CAR ACCIDENT, THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. PROGRAMMING OPTIMIZATION AROUND THE IMPEDANCES INITIALLY WORKED; HOWEVER, OVER TIME, THE STIMULATION BECAME LESS EFFECTIVE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW SYSTEM. THE PATIENT WAS RECOVERING WITH ADEQUATE STIMULATION POSTOPERATIVELY. THE LEADS AND LEAD SPLITTERS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 22129635 ↗
• InjuryMay 28, 2025Unexpected Therapeutic Results; Charging Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE LEADS MIGRATED. THE PATIENT WAS ALSO EXPERIENCING IMPLANTABLE PULSE GENERATOR (IPG) CHARGING DIFFICULTIES. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 22101644 ↗
• InjuryApr 25, 2025High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES, AND AN X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909652 ↗
• InjuryApr 23, 2025High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS MIGRATED WHICH WAS CONFIRMED BY XRAY. THE LEADS ALSO DISPLAYED HIGH IMPEDANCES ON MULTIPLE CONTACTS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894994 ↗
• InjuryMar 26, 2025High impedance; Unexpected Therapeutic Results; Charging Problem; High impedance; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND MORE FREQUENT CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG). HIGH IMPEDANCE READINGS WERE DISCOVERED ON SEVERAL CONTACTS OF THE THORACIC LEADS. THEREFORE, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE DURING WHICH THE SCS SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW IPG AND TWO NEW LEADS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21701626 ↗
• InjuryFeb 25, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE LEAD HAD MULTIPLE IMPEDANCES, AND THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN THE INFINION LEAD WAS REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 21463403 ↗
• MalfunctionFeb 9, 2025Fracture; High impedance; Charging Problem; Device Dislodged or Dislocated; Fracture; High impedance; Charging Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD FRACTURED, WHICH WAS CONFIRMED THROUGH X-RAY. NO FURTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEAD BROKE AND LEFT CONTACTS IN THE UPPER SPACE. IT WAS ALSO MENTIONED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT HOLDING A CHARGE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE NOT RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340764 ↗
• InjuryNov 15, 2024High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS PERFORMED BUT WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEADS WERE REPLACED AND THE SPLITTERS WERE REMOVED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 20700246 ↗
• InjuryNov 13, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION (SCS) TRIAL THE PATIENT EXPERIENCED STIMULATION IN A NON-TARGET AREA. X-RAY IMAGING CONFIRMED THAT BOTH SCS LEADS MIGRATED. THE PATIENT UNDERWENT AN EARLY LEAD PULL IN WHICH BOTH LEADS WERE EXPLANTED. THE EXPLANTED TRIAL LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. THE PATIENT WAS RECOVERING AS EXPECTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678932 ↗
• InjuryOct 17, 2024Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. IT WAS STATED THAT THE PATIENT WAS EXPERIENCING FIRING TO THE UPPER ARM AND LEG AND CURRENTLY, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS TURNED OFF. IT WAS ALSO STATED THAT THE PATIENT WAS PROGRAMMED PRIOR TO SURGERY AND RECEIVED ADEQUATE COVERAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD, SPLITTER AND IPG WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477863 ↗
• InjurySep 18, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE SPINAL CORD STIMULATOR (SCS) LINEAR LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WERE NOT RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 20252343 ↗
• InjurySep 10, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. X-RAY REVEALED LEAD MIGRATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 20185354 ↗
• InjurySep 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING A PROGRAMMING SESSION, HIGH IMPEDANCES MEASUREMENTS WERE DISCOVERED ON THE SPINAL CORD STIMULATION (SCS) PATIENT'S LEADS. DESPITE PROGRAMMING HAVING SUCCESSFULLY COVERED ALL PAIN AREAS USING THE UNAFFECTED CONTACTS, THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED, AND THE SPLITTERS REMOVED. THE PATIENT DID WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152340 ↗
• InjuryJun 11, 2024High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. HIGH IMPEDANCES WERE OBSERVED ON THE SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH LEADS AND SPLITTERS WERE REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECOVERED. THE EXPLANTED DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 19515863 ↗
• InjuryMay 15, 2024High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT HIGH IMPEDANCES WERE DISPLAYED ON MOST OF THE CONTACTS ON ONE SPINAL CORD STIMULATION LEAD WHICH RESULTED IN INADEQUATE STIMULATION EFFICACY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND THE REST OF THE SYSTEM WAS REPLACED WITH AN UPGRADED SYSTEM. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THERE WERE NO ALLEGATIONS AGAINST THE OTHER DEVICES. THE SUSPECT LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19327115 ↗
• InjuryMar 19, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE IMPLANTED LEADS. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED WITH LEADS OF A DIFFERENT MODEL. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT HAD SIGNIFICANT PAIN RELIEF POST OPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 18937523 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) TRIAL TESTING PERIOD, THE PATIENT EXPERIENCED NUMBNESS AND CHANGE IN STRENGTH IN HER LEFT HAND SINCE THE PROCEDURE. THE PHYSICIAN DECIDED TO EXPLANT THE TRIAL LEADS EARLY TO BE ON THE SAFE SIDE. POSTOPERATIVELY THE NUMBNESS AS MINIMALLY RESOLVED, BUT NOT COMPLETELY. THE PATIENT REPORTED A BRUISE ON THE OUTSIDE OF HER UPPER ARM WHICH SHE BELIEVES TO BE RELATED TO HER SYMPTOMS. THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) AND THERE WAS NO EVIDENCE OF CORD CONTUSION OR HEMATOMA. THE PHYSICIAN ASSESSED THAT THERE WAS NO CLEAR CAUSE FOR THE PATIENTS SYMPTOMS. HE FELT THEY WERE LIKELY UNRELATED TO THE PROCEDURE OR STIMULATOR, AND RATHER SYMPTOMS OF MINOR TRAUMA OR FIBROMYALGIA. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

  Patient problems: Numbness; Undesired Nerve Stimulation

  MAUDE report 18844832 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.