WaveWriter Alpha™ SC-1232Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,347 adverse event reports that list this exact device (DI 08714729985099), received between Feb 16, 2021 and Sep 30, 2026 — classified as 41 deaths, 4,260 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (1,104 reports).

1 FDA recall record name this device's identifier, 1 still open.

16 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.

Recalls naming this device

1. Jul 17, 2024Open, Classified

   Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

   Z-2617-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,347 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50955194 ↗
• InjurySep 30, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954719 ↗
• InjurySep 30, 2026Charging Problem

  Patient problems: Back pain; Pain

  MAUDE report 50952860 ↗
• InjurySep 30, 2026Migration

  Patient problems: Implant Pain

  MAUDE report 50951798 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50949832 ↗
• InjurySep 30, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949343 ↗
• InjurySep 30, 2026Wireless Communication Problem

  It was reported that the patient was hospitalized for an unknown reason. The implantable pulse generator (IPG) had difficulty communicating with the remote. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947146 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implantable pulse generator (IPG) site appeared to be infected. Laboratory testing was performed, and the white blood cell count was reported to be within normal limits. The physician indicated that the event was not believed to be related to the stimulator and noted that the patient had diabetes with a history of poor healing. All device components were explanted and were not returned for evaluation. The patient was doing well postoperatively.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 50944762 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50940886 ↗
• InjurySep 29, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938246 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938242 ↗
• InjurySep 29, 2026Nonstandard Device

  It was reported that the patient was involved in a motor bike accident which caused the spinal cord stimulator (SCS) implantable pulse generator (IPG) to be damaged. It was stated that there was no issue with the devices prior to the accident. The patient underwent a revision procedure where the IPG and SCS leads were removed and replaced. The device had been turned off since the accident and battery depleted so it was not possible to see what was working and what was not therefore, both the IPG and leads were replaced. Post operatively, the patient was stable. The explanted devices will not be returned as they were disposed by the physician.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936045 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that patient is experiencing pain and feels a strong shocking feeling on left heel.

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50933347 ↗
• MalfunctionSep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient felt a zap near the Implantable Pulse Generator (IPG) site.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930231 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was in a rehabilitation facility due to a spinal fusion procedure. It was unknown if it was device related.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929195 ↗
• InjurySep 28, 2026High impedance

  Patient problems: Fall

  MAUDE report 50922566 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50917236 ↗
• InjurySep 28, 2026Charging Problem; Migration

  Patient problems: Discomfort

  MAUDE report 50916733 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient was experiencing inadequate pain relief. It was noted that the implantable pulse generator (IPG) would not hold a charge. The patient underwent a Spinal Cord Stimulator (SCS) explant procedure and was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50916065 ↗
• InjurySep 28, 2026Fracture; Migration

  It was reported that the patients implantable pulse generator (IPG) has migrated causing pain at the implant site. The patient underwent a revision procedure, upon impedance check, found that one lead was completely fractured with high impedances, physician decided to swap the IPG remove the bad lead and insert a new lead. The patient was doing well postoperatively. The explanted device was not returned.

  Patient problems: Bladder Dysfunction; Discomfort; Implant Pain

  MAUDE report 50915507 ↗
• InjurySep 28, 2026Charging Problem

  Patient problems: Discomfort; Pain

  MAUDE report 50915450 ↗
• InjurySep 28, 2026Charging Problem

  It was reported that the patient was having difficulty charging the Implantable Pulse Generator (IPG) due to placement. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913961 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate stimulation. The patient underwent a procedure wherein the IPG and spinal cord stimulator (SCS) leads were explanted. The patient was doing well postoperatively and the explanted devices were retained by the medical facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50912854 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results

  It was reported that all components were explanted due to inadequate and loss of stimulation. No further information has been obtained despite good faith efforts.

  Patient problems: Pain

  MAUDE report 50910715 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing a postoperative pain and was sent to the Emergency Department. Per physician, the implant procedure exacerbated patients Complex regional pain syndrome (CRPS) symptoms, but there was no evidence of device failure or misplacement to blame. The patient was discharged and was doing well.

  Patient problems: Pain

  MAUDE report 50910678 ↗

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-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-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-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
• Z-0299-2007 · Sep 21, 2006 · Terminated
  Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.

…and 1 more.