WaveWriter Alpha™ 16 SC-1216Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,190 adverse event reports that list this exact device (DI 08714729985082), received between Jan 4, 2021 and Sep 30, 2026 — classified as 29 deaths, 2,111 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (589 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,190 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Spinal Cord Stimulation (SCS) patient passed away. The cause of death was not related to the device or stimulation; however, the exact cause of death remains unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955116 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50955107 ↗
• MalfunctionSep 30, 2026Inappropriate or Unexpected Reset

  The spinal cord stimulation (SCS) implantable pulse generator (IPG) database analysis performed identified a Bluetooth fault code when charging the IPG. Noise from the charging field of the charger interferes with the Bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation. The IPG remains implanted in the patient and delivering therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949403 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  It was reported that the patients implantable pulse generator (IPG) was not providing adequate pain relief. The patient underwent a Spinal Cord Stimulator (SCS) explant procedure. The explanted device was discarded. No further information has been obtained.

  Patient problems: Pain

  MAUDE report 50946734 ↗
• InjurySep 30, 2026Unexpected Therapeutic Results

  It was reported that the patients implantable pulse generator (IPG) was not providing adequate pain relief. The patient underwent an IPG explant procedure. The explanted device was not returned. No further information has been obtained.

  Patient problems: Pain

  MAUDE report 50946442 ↗
• MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Insufficient Device Problem Information

  It was reported that the patients Implantable Pulse Generator (IPG) has failed to provide meaningful or lasting therapeutic benefit. The device caused worsening pain and patient experienced an overstimulation. The implant site remains sore, with thinned skin through which the device imprint remains visible and palpable.

  Patient problems: Erosion; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50943210 ↗
• InjurySep 29, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938646 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932838 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results; Charging Problem

  Patient problems: Pain

  MAUDE report 50932351 ↗
• InjurySep 29, 2026Positioning Problem; Migration

  It was reported that the patient's implantable pulse generator (IPG) was sitting perpendicular to the surface of the skin causing charging difficulties. The patient underwent an IPG replacement procedure and was doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930167 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929787 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing a lower back pain and was prescribed with medication.

  Patient problems: Pain

  MAUDE report 50928179 ↗
• DeathSep 29, 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 the device or stimulation; however, this has not been confirmed. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927841 ↗
• InjurySep 28, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917014 ↗
• InjurySep 28, 2026Battery Problem

  It was reported that the patients implantable pulse generator (IPG) had reached the end of its service life. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was not returned in accordance with facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915300 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Diarrhea; Ulcer; Unspecified Infection

  MAUDE report 50915240 ↗
• InjurySep 28, 2026Nonstandard Device

  Patient problems: Insufficient Information

  MAUDE report 50915111 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Paresthesia

  MAUDE report 50904256 ↗
• InjurySep 25, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902772 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient was experiencing overstimulation sensations. The patient underwent spinal cord stimulation (SCS) explant procedure. The explanted items were kept by the facility.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50898540 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results

  Patient problems: Pain; Tissue Irritation

  MAUDE report 50891494 ↗
• MalfunctionSep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Fall; Inappropriate Device Stimulation of Tissue

  MAUDE report 50888541 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient was experiencing difficulty charging and inadequate pain relief the Implantable Pulse Generator (IPG). The patient underwent an IPG and Lead replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: Pain

  MAUDE report 50878504 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent explant procedure due to an unknown reason. The patient was doing well postoperatively. Explanted device was disposed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878496 ↗
• InjurySep 24, 2026Nonstandard Device

  It was reported that the patients Implantable Pulse Generator (IPG) was no longer working as intended. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG will not be returned per hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877667 ↗

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-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-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-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-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-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-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.