WaveWriter Alpha™ Prime SC-1432Recalls & reported problems

Summary

The FDA's MAUDE database contains 971 adverse event reports that list this exact device (DI 08714729985075), received between Nov 5, 2020 and Sep 29, 2026 — classified as 7 deaths, 962 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (348 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 971 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932506 ↗
• InjurySep 29, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929811 ↗
• InjurySep 29, 2026Battery Problem

  It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended after receiving the end of life message. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929782 ↗
• InjurySep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916419 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50916370 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent Implantable Pulse Generator (IPG) replacement procedure due to an unknown reason.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914731 ↗
• InjurySep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914262 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results; Battery Problem

  It was reported that the patient experienced a loss of stimulation due to the Implantable Pulse Generator (IPG) being at the End of Battery Life Thus, the patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was not returned due to facilitys policy.

  Patient problems: Pain

  MAUDE report 50913962 ↗
• InjurySep 25, 2026Battery Problem

  It was reported that the patient's IPG had reached End of Life. The patient underwent an IPG replacement 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 50895532 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results; Battery Problem

  Patient problems: Pain

  MAUDE report 50892555 ↗
• InjurySep 24, 2026Battery Problem

  It was reported that the patient received an End of Life message on the Spinal Cord Stimulator (SCS) remote and the IPG was no longer working. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned as it was disposed of by the facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888498 ↗
• DeathSep 23, 2026Unexpected Therapeutic Results; Insufficient Device Problem Information

  It was reported that a spinal cord stimulation (SCS) patient following the implantable pulse generator (IPG), patient began experiencing recurrent and progressively worsening discomfort, pain, and complications at or associated with the site of the IPG. A large mass developed at the location of the IPG and treating physician expressed that the patient was getting infections from the stimulator and that the infections were getting worse. Despite medical intervention, the infections and complications persisted and escalated in severity. Later on, patient presented again with physician with ongoing back and leg pain and a request for stimulator removal due to it becoming infective; lack of any relief; and pain, particularly at the site of the battery. Due this request, physician performed the explant of the entire system. After the explant, patient continued to experience fever, back pain, and weakness consistent with ongoing spinal infection. This infection progressed to life-threatening multilevel spinal infections and systemic sepsis. Specifically, imaging and clinical findings revealed: T7-T11 and right T2 epidural abscess/phlegmon; T12-L2 discitis/osteomyelitis with associated ab

  Patient problems: Abscess; Sepsis; Unspecified Infection

  MAUDE report 50876059 ↗
• InjurySep 23, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50874047 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results

  It was reported that the patients spinal cord stimulator (SCS) was not providing relief. All device components were explanted and were not returned. The patient was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50851575 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a Spinal Cord Stimulator (SCS) System explant procedure due to infection. The explanted device components were not returned. No further information could be obtained despite good faith efforts.

  Patient problems: Unspecified Infection

  MAUDE report 50837868 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all components were explanted due to an unknown reason. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835319 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that all components were explanted due to an unknown reason. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835266 ↗
• InjurySep 18, 2026Unexpected Therapeutic Results; Battery Problem

  Patient problems: Pain

  MAUDE report 50829443 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort

  MAUDE report 50829405 ↗
• InjurySep 17, 2026Battery Problem

  Patient problems: Nerve Damage; Pain

  MAUDE report 50812651 ↗
• InjurySep 17, 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 replaced device is unknown. Additional information has been requested but it is unavailable per customer account.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809857 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away, the cause of death remains unknown. It was noted that the patient had extensive comorbidities including history of stroke and seizures prior to the SCS system implantation, no known recent procedures were performed.

  Patient problems: Convulsion/Seizure; Ischemia Stroke

  MAUDE report 50797131 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796871 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796867 ↗
• InjurySep 16, 2026High impedance; Adverse Event Without Identified Device or Use Problem; Migration

  Patient problems: Fluid Discharge; Inappropriate Device Stimulation of Tissue; Weight Changes

  MAUDE report 50796411 ↗

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-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-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-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.