Spectra WaveWriter™ SC-1160Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,221 adverse event reports that list this exact device (DI 08714729951254), received between Sep 11, 2017 and Sep 30, 2026 — classified as 31 deaths, 7,181 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (2,324 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 7,221 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Charging Problem

  It was reported that the patient's Implantable Pulse Generator (IPG) was not holding a charge. The patient underwent a procedure wherein the IPG was replaced with an MRI compatible device and that the was doing well postoperatively. The explanted IPG was retained by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945099 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  It was reported that the patients spinal cord stimulator (SCS) was not providing stimulation. All device components were explanted. No further information has been obtained despite good faith efforts.

  Patient problems: Pain

  MAUDE report 50944565 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results; Insufficient Device Problem Information

  It was reported that the patient experienced an inadequate stimulation despite multiple program optimization. The patient underwent an Implantable Pulse Generator (IPG) explant procedure. No further information has been obtained.

  Patient problems: Pain

  MAUDE report 50943332 ↗
• InjurySep 30, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941569 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  It was reported that the spinal cord stimulation (SCS) patient underwent explant of the system due to patient dissatisfaction with therapy and persistent implantable pulse generator (IPG) pocket pain. No patient complications were reported. The onset date of the issue was unavailable. The patient underwent explant of the system and was reported to be doing well postoperatively. The explanted devices were disposed of per facility policy and were not returned for analysis.

  Patient problems: Pain

  MAUDE report 50934988 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  Patient problems: Back pain

  MAUDE report 50932968 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  It was reported that the patients Implantable Pulse Generator (IPG) was experiencing loss of stimulation and pain the Leads had high impedances. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: Implant Pain

  MAUDE report 50929783 ↗
• InjurySep 28, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915669 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50915666 ↗
• InjurySep 28, 2026Charging Problem

  It was reported that the patient was having difficulty charging the Implantable Pulse Generator (IPG). The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was discarded by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913814 ↗
• InjurySep 26, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908351 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away. The cause of death is not believed to be related to stimulation; however, it remains unconfirmed. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902771 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50902701 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate pain relief. It was also stated that the device was causing more pain. The patient underwent Implantable Pulse Generator (IPG) explant procedure.

  Patient problems: Pain

  MAUDE report 50898596 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate stimulation and worsening pain. It was also stated that the patient felt numbness and tingling in the legs. The patient underwent a procedure wherein the IPG was replaced with an MRI compatible device. The patient was doing well postoperatively.

  Patient problems: Numbness; Pain; Paresthesia

  MAUDE report 50897599 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876086 ↗
• InjurySep 23, 2026Unexpected Therapeutic Results

  Patient problems: Fall; Pain

  MAUDE report 50875826 ↗
• InjurySep 23, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874510 ↗
• InjurySep 23, 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 replaced device is unknown. Additional information was requested; however, this information regarding this event was Unavailable per customer and account.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872024 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an implantable pulse generator (IPG) explant procedure due to an unknown reason. The patient was doing well postoperatively. No further information could be obtained despite good faith efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869028 ↗
• InjurySep 23, 2026Fracture; Nonstandard Device; Unexpected Therapeutic Results

  It was reported that the patients Implantable Pulse Generator (IPG) was no longer working as intended. It was also reported that after a fall, the leads were fractured preventing patient from Magnetic Resonance Imaging (MRI) access and stimulation therapy coverage. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure and was doing well postoperatively. The explanted products will not be returned per hospital policy.

  Patient problems: Pain

  MAUDE report 50865011 ↗
• InjurySep 22, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862916 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a Spinal Cord Stimulator (SCS) revision procedure due to an unknown reason.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858715 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient underwent a system revision to obtain MRI compatibility, but the leads presented impedances and then appeared inadequate stimulation issues. No patient complications were reported. The explanted devices were discarded per hospital policy and were not returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855058 ↗
• InjurySep 22, 2026Charging Problem

  It was reported that the patient was unable to charge the Implantable Pulse Generator (IPG). The patient stated that the recommended cycle charging process was performed however, the stimulator would not charge. The patient underwent IPG replacement procedure and was doing well postoperatively. The explanted device will not be returned per physician's preference.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852996 ↗

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-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-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-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-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-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.