Spectra WaveWriter™ SC-1060-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729953432), received between May 22, 2019 and May 13, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Charging Problem” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE DUE HAVING INCREASED CHARGING TIME AND ALSO WANTED MAGNETIC RESONANCE IMAGING (MRI) CAPABILITIES. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED. ELECTROCAUTERY WAS USED. THE PATIENT WAS STABLE POST OPERATION AND DOING GREAT. THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166436 ↗
• InjuryMar 30, 2026Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO CHARGING DIFFICULTIES AS PATIENT HAD TO CHARGING MORE FREQUENTLY THE IPG. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS FACILITY PROTOCOL PROHIBITS DEVICE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736649 ↗
• InjuryMar 20, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REPLACEMENT PROCEDURE BECAUSE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER PROVIDING THERAPY. THE DEVICE WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THERAPY WAS RESUMED WITHOUT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 24652022 ↗
• InjuryMar 19, 2026Charging 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: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645967 ↗
• InjuryJan 28, 2026High impedance; Unexpected Therapeutic Results; Charging Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CAR ACCIDENT AND WAS NOT GETTING ADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT HAD UNDESIRED STIMULATION AT THE SPINE AND HAD WEAKNESS WHENEVER THE STIMULATION WAS ON. IT WAS ALSO REPORTED THAT THE PATIENT HAD TO CHARGE THE IMPLANTABLE PULSE GENERATOR (IPG) MORE FREQUENTLY AFTER THE ACCIDENT. THERE WERE HIGH IMPEDANCES NOTED ON THE LEADS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Headache; Inappropriate Device Stimulation of Tissue; Muscle Weakness/Atrophy; Pain; Undesired Nerve Stimulation

  MAUDE report 24199638 ↗
• InjuryJan 13, 2026Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO DIFFICULTIES CHARGING. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS DISCARDED PER HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO POSTOPERATIVE COMPLICATIONS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059932 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use 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 23438661 ↗
• 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 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 23425757 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397779 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use 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 23080552 ↗
• InjuryJul 14, 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) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493961 ↗
• InjuryMay 27, 2025Charging Problem; Migration; Charging Problem; Migration

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT IMAGING WAS TAKEN AND SHOWED THAT THE LEFT LEAD WAS ANTERIOR AND MAY HAVE MIGRATED. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093315 ↗
• InjuryApr 29, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO CHARGING DIFFICULTIES, THE PATIENT IS RECOVERING WELL. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS RETAINED BY FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925445 ↗
• InjuryApr 29, 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924031 ↗
• InjuryJan 30, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON... THE PATIENT IS DOING GREAT POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279801 ↗
• InjuryOct 15, 2024Unexpected Therapeutic Results; Charging Problem; Wireless Communication Problem; Unexpected Therapeutic Results; Charging Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) HAD DIFFICULTY COMMUNICATING WITH THE REMOTE CONTROL. IT WAS ALSO NOTED THAT THE IPG WOULD NOT HOLD A CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

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

  MAUDE report 20457080 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS 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 20083140 ↗
• InjuryAug 28, 2024Charging 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) SYSTEM WAS REPLACED DUE TO AN INCREASED CHARGING BURDEN OF THE IMPLANTABLE PULSE GENERATOR (IPG) AS WELL AS A DECREASE IN EFFICACY OF THERAPY WHEN THE BATTERY WAS LOW. THE PATIENT IS GETTING GOOD PAIN RELIEF POST OPERATIVELY. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS NOT USED NEAR NEW IPG.

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

  MAUDE report 20083108 ↗
• InjuryJun 19, 2024Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO FREQUENTLY CHARGE THE IPG AND EXPERIENCED AN INADEQUATE STIMULATION. THE LEADS HAD HIGH IMPEDANCES. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571218 ↗
• InjuryFeb 26, 2024Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) HAD MOVED TOWARDS THE SPINE CAUSING INTERMITTENT AND UNDESIRED STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18785027 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057064 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN AN MRI COMPATIBLE IPG WAS IMPLANTED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT AT THE FACILITY.

  Patient problems: Implant Pain

  MAUDE report 17031413 ↗
• InjuryMar 13, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPGS WERE NOT RETURNED PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16533710 ↗
• InjuryJan 26, 2023Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENTS IPG WOULD NOT HOLD A CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245253 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD AN AUTOIMMUNE DISORDER FROM THE PAST. IT WAS ALSO REPORTED THAT FOLLOWING POST PLACEMENT OF SCS THE PATIENT WAS EXPERIENCING SERIOUS DRAINAGE AND WAS TREATED BY INFECTIOUS DISEASE PHYSICIAN. THE PHYSICIAN STATED THAT PATIENT HAD GROWN A NON-STAPHYLOCOCCAL ORGANISM. THE PATIENT WILL UNDERGO EXPLANT.

  Patient problems: Complaint, Ill-Defined; Unspecified Infection

  MAUDE report 8985886 ↗

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-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-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-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-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-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.