Precision Spectra™ SC-1032BRecalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 08714729861539), received between Dec 8, 2016 and Sep 2, 2026 — classified as 2 deaths, 74 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (31 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 78 reports, in the reporter's own words as published by the FDA.

• DeathSep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a spinal cord stimulation (SCS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570886 ↗
• DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENTS DAUGHTER THAT THE PATIENT PASSED AWAY. THE PATIENTS DAUGHTER ADVISED THAT THE CAUSE OF DEATH WAS NOT SPINAL CORD STIMULATION (SCS) DEVICE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445432 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333490 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088251 ↗
• InjuryApr 29, 2026Nonstandard Device; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) HAD STOPPED WORKING AFTER A FALL. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 25031375 ↗
• InjuryApr 22, 2026Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) AND AS PART OF THE INTERVENTION, THE IPG WAS REPLACED. ELECTROCAUTERY WAS USED DURING THE PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL AND TO HAVE RECOVERED. THE EXPLANTED IPG WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS RETAINED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954774 ↗
• InjuryMar 30, 2026Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). AS A RESULT, THE PHYSICIAN RECOMMENDED UPGRADING TO NEWER TECHNOLOGY TO IMPROVE PAIN MANAGEMENT. CONSEQUENTLY, THE IPG WAS REPLACED. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715382 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24357866 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089912 ↗
• InjuryJan 5, 2026Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT THE REPLACEMENT PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) NOT HOLDING A CHARGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968882 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS PATIENT UNDERWENT AN ELECTIVE EXPLANT PROCEDURE, AS THE SCS SYSTEM WAS NO LONGER REQUIRED FOR TREATMENT. NO DEVICE MALFUNCTION OR PATIENT ADVERSE EVENTS WERE REPORTED. THE IMPLANTABLE PULSE GENERATOR (IPG) AND PADDLE LEAD WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818537 ↗
• InjuryDec 11, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO DIFFICULTIES CHARGING. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE LOCATION OF THE DEVICE IS UNKNOWN. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785768 ↗
• InjuryDec 11, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO DIFFICULTIES CHARGING. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE LOCATION OF THE DEVICE IS UNKNOWN. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785758 ↗
• InjuryDec 4, 2025Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS PATIENT UNDERWENT THE REPLACEMENT PROCEDURE DUE TO DISCONTINUATION OF IMPLANTABLE PULSE GENERATOR (IPG) USE FOR OVER TWO YEARS, WHICH RESULTED IN AN UNRESPONSIVE IPG. ELECTROCAUTERY WAS USED. THE IPG WAS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SCS REPLACEMENT WAS PERFORMED IN ACCORDANCE WITH THE PHYSICIAN AND PATIENT DECISION.

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

  MAUDE report 23716136 ↗
• InjuryDec 1, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PROCEDURE WENT WITHOUT INCIDENT AND THE PATIENT IS DOING GREAT POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. NOTHING WILL BE RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680041 ↗
• InjuryOct 30, 2025Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE EXPLANTED DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430403 ↗
• InjuryOct 30, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT THE PROCEDURE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) NO HOLDING A CHARGE. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE SURGERY WENT GREAT AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426536 ↗
• InjuryOct 26, 2025Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO CHARGING DIFFICULTIES. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387869 ↗
• InjuryOct 21, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. PATIENT RECOVERED POSTOPERATIVELY. THE EXPLANTED DEVICE UNABLE TO RETURN PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347508 ↗
• InjuryOct 6, 2025Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS PATIENT UNDERWENT THE PROCEDURE DUE TO DIFFICULTIES CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE NEW IPG WAS PROGRAMMED AND THE PATIENT REPORTED RECEIVING SATISFACTORY THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23230047 ↗
• InjuryOct 2, 2025Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO FREQUENT CHARGING. THE IPG WAS RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL AND REPORTED SIGNIFICANT RELIEF FROM THE DEVICE. THE PATIENT ALSO INDICATED USING THE DEVICE DAILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23205697 ↗
• InjurySep 19, 2025Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098242 ↗
• InjurySep 10, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022146 ↗
• InjurySep 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987371 ↗
• InjuryAug 29, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS DISCARDED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920501 ↗

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-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-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-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-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-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-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.