WaveWriter Alpha™ SC-5170Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729994657), received between Jun 9, 2021 and Sep 30, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50954723 ↗
• InjuryJun 4, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD NEGATIVE OUTCOMES FROM SPINAL CORD STIMULATION (SCS) TRIAL. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 25399443 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO CONSTANT THROWING UP AND PAIN. IT WAS NOTED THAT PATIENT HAD A REACTION ON THE ANESTHESIA AND THERE WERE NO ISSUES WITH THE DEVICE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 24770250 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING A HEART ATTACK AND WAS SENT TO THE EMERGENCY ROOM. IT WAS NOTED THAT PATIENT WAS FULLY CHECKED AND DEFORMED TO BE HAVING AN ANXIETY ATTACK. THE PATIENT WAS HAVING STRUGGLE WITH THE ANXIETY AND WAS PRESCRIBED MEDICATION. PATIENTS ANXIETY ATTACK WAS NOT DEVICE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579272 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND TRIMMERS AND THE PROCEDURE WAS CANCELLED. THE PHYSICIAN NOTED THAT THERE WAS NOT ANYTHING ABNORMAL WITH THE TRIAL AND THAT THE PATIENT MAY HAVE SOME TYPE OF OCD. ALSO MENTIONED THE PATIENT WAS POSSIBLY GOING THROUGH WITHDRAW BECAUSE HE HAD TAKEN ALL OF HIS PAIN MEDICATION THE FIRST NIGHT AFTER THE TRIAL. X-RAYS WERE TAKEN AND THE LEADS HAD LITTLE TO NO MIGRATION AND REMAINED POSTERIOR.

  Patient problems: Pain; Shaking/Tremors

  MAUDE report 15893548 ↗
• InjuryMay 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE (B)(6) CLINICAL TRIAL, EXPERIENCED WORSENED NEUROPATHIC LEFT LOWER EXTREMITY PAIN. THE PATIENT WAS PRESCRIBED NON-OPIOID MEDICATIONS. THE PATIENT'S STIMULATION WAS NOT YET TURNED ON. THE EVENT IS RESOLVING. THE NON-SERIOUS ADVERSE EVENT WAS REPORTED AS CAUSALLY RELATED TO PROCEDURE AND NOT RELATED TO DEVICE HARDWARE AND OR STIMULATION.

  Patient problems: Pain

  MAUDE report 14258156 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST SPINAL CORD STIMULATION IMPLANT PROCEDURE THE PATIENT EXPERIENCED MUSCLE SPASMS IN THE LEFT LOWER BACK. THE PHYSICIAN SUSPECTED LEAD PLACEMENT MAY HAVE BEEN THE CAUSE OF THE MUSCLE SPASM. THE PHYSICIAN ADMINISTERED A MUSCLE RELAXER AND THE PATIENT WAS DOING OK. THE INVESTIGATORS REPORTED THE RELATIONSHIP TO PROCEDURE WAS REPORTED AS POSSIBLE. THE RELATIONSHIP TO DEVICE STIMULATION WAS REPORTED AS POSSIBLE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Undesired Nerve Stimulation

  MAUDE report 14025152 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CRAMPING DURING THE TRIAL PERIOD WITH A COMPETITIVE LEAD CONNECTED TO A BOSTON SCIENTIFIC EXTERNAL TRIAL STIMULATOR (ETS). THE PHYSICIAN ASSESSED THAT THIS IS A COMMON SIDE EFFECT, BUT THE PATIENT WAS KEPT IN THE HOSPITAL FOR OBSERVATION AND THE EVENT SUBSIDED AFTER A FEW HOURS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Undesired Nerve Stimulation

  MAUDE report 11968627 ↗

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-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-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-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-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.