WaveWriter Alpha™ Prime 16 SC-1416Recalls & reported problems

Summary

The FDA's MAUDE database contains 911 adverse event reports that list this exact device (DI 08714729985068), received between Nov 13, 2020 and Sep 30, 2026 — classified as 12 deaths, 887 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (272 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 911 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Discomfort

  MAUDE report 50954780 ↗
• InjurySep 30, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952330 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Wireless Communication Problem

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50932953 ↗
• 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 stimulation; however, it remains unconfirmed. No further information has been obtained. The Implantable pulse generator (IPG) was returned and will undergo analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931537 ↗
• InjurySep 29, 2026Battery Problem

  It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended. 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 50929813 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced an inadequate stimulation. The patient underwent an explant procedure and was doing well postoperatively. The explanted products were discarded per hospital policy.

  Patient problems: Pain

  MAUDE report 50928252 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50906268 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was admitted and was successfully programmed where an impedance check performed and confirmed to be working appropriately. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879662 ↗
• InjurySep 23, 2026Wireless Communication Problem

  Patient problems: Abdominal Pain; Back pain; Insufficient Information

  MAUDE report 50874045 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was experiencing pain at the implantable pulse generator (IPG) pocket site. The patient went to ER. The hospitalization was due to procedural pain. No further action needed at this time.

  Patient problems: Implant Pain

  MAUDE report 50868763 ↗
• InjurySep 23, 2026Unexpected Therapeutic Results; Battery Problem

  It was reported that the patient with a Wavewriter Alpha Prime was a high energy user and the patient's IPG had reached End of Life. The physician found an infection at the pocket site during a revision procedure and decided to explant the IPG including the spinal cord stimulator paddle (SCS) lead.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50866067 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results

  Patient problems: Discomfort; Pain

  MAUDE report 50860413 ↗
• DeathSep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away for an unknown reason. Additional information was not provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859860 ↗
• InjurySep 17, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing complications like shocking and poor pain relief despite multiple device optimizations.

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50802941 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795989 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793609 ↗
• InjurySep 16, 2026Battery Problem

  It was reported that the patient's implantable pulse generator (IPG) had reached End of Life and the patient was experiencing increased pain which described as aching, shock like, tiring and exhausting. The patient underwent an IPG replacement procedure and was doing well postoperatively.

  Patient problems: Pain

  MAUDE report 50786095 ↗
• InjurySep 16, 2026Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate pain relief. The patient underwent a Spinal Cord Stimulator (SCS) system explant procedure and was doing well postoperatively. The explanted device components were not returned.

  Patient problems: Pain

  MAUDE report 50784993 ↗
• InjurySep 15, 2026Unexpected Therapeutic Results; Battery Problem

  Patient problems: Discomfort; Pain; Urinary Incontinence

  MAUDE report 50779969 ↗
• InjurySep 15, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Pain

  MAUDE report 50779964 ↗
• InjurySep 15, 2026Wireless Communication Problem

  It was reported that the patient was experiencing pain as Implantable Pulse Generator (IPG) could not connect to cellphone. The patient underwent Implantable Pulse Generator (IPG) replacement procedure. During standard Implantable Pulse Generator (IPG) replacement, it was discovered that the paddle leads had high impedances and was fractured. Patient was stable postoperatively. The explanted device was disposed.

  Patient problems: Pain

  MAUDE report 50773880 ↗
• InjurySep 14, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50765713 ↗
• InjurySep 9, 2026Battery Problem

  It was reported that the spinal cord stimulation (SCS) patient underwent a revision due to the implantable pulse generator (IPG) reaching end of life (EOL). No patient complications were reported. The patient was reported to be doing well postoperatively with excellent coverage of all painful areas. The explanted device was not returned for analysis due to hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694387 ↗
• InjurySep 4, 2026Migration

  Patient problems: Erosion

  MAUDE report 50619500 ↗
• InjurySep 4, 2026Battery Problem

  It was reported that the Spinal Cord Stimulation (SCS) patient underwent an explant procedure due to the implantable pulse generator (IPG) displaying an End of Service (EOS) message. It was noted that the device did not achieve its expected service life before reaching end of life. The IPG was subsequently explanted and replaced. Per facility policy, the explanted device will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612243 ↗

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-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-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-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.