Precision™ SC-1010CRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729821519), received between Dec 2, 2016 and Aug 11, 2026 — classified as 2 deaths, 36 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (14 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 45 reports, in the reporter's own words as published by the FDA.

• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away. It was stated that the cause was not device related, however, the specific cause is not known. No further information was obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201467 ↗
• InjuryMar 31, 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 IMPLANTABLE PULSE GENERATOR (IPG) IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742497 ↗
• InjuryNov 27, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667624 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438915 ↗
• InjuryOct 2, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NO LONGER CHARGE. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23198185 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REVISED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23139957 ↗
• InjuryJul 24, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NOT FULLY CHARGE DESPITE TROUBLESHOOTING ATTEMPTS. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22602334 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470778 ↗
• InjuryJul 8, 2025Charging Problem; Impedance Problem; Charging Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE LEADS HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440824 ↗
• InjuryJun 9, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO CHARGING DIFFICULTIES AND MAGNETIC RESONANCE IMAGING (MRI) PREFERENCES. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172428 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162604 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED BECAUSE THE PATIENT HAD NOT USED THEIR STIMULATOR FOR YEARS, THOUGH THE UNDERLYING REASON REMAINS UNKNOWN. ADDITIONALLY, THE PATIENT REQUIRED A BATTERY UPGRADE FOR MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY AND UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE, DURING WHICH THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT IS DOING WELL POST-OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111132 ↗
• InjuryMar 24, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO CHARGING DIFFICULTIES. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT IS DOING WELL POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21683480 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO UNKNOWN REASON. THE PATIENT IS HAPPY AND DOING GREAT POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292812 ↗
• InjuryOct 15, 2024Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO THE PATIENT COMPLAINED OF IMPLANTABLE PULSE GENERATOR (IPG) DEPLETING QUICKLY AND TAKING LONGER TO CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT, AND HE HAS GREAT COVERAGE OVER HIS PAIN AREAS. EXPLANTED DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452731 ↗
• InjuryAug 20, 2024Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008210 ↗
• InjuryAug 22, 2023Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. IT WAS NOTED ALSO THAT PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17594061 ↗
• InjuryApr 14, 2023High impedance; Charging Problem; Wireless Communication Problem; High impedance; Charging Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED THAT ALL CONTACTS ON PATIENTS LEAD WERE OUT. IT WAS NOTED ALSO THAT ONLY ONE LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744230 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497074 ↗
• InjuryAug 25, 2020Adverse 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 WAS HOSPITALIZED. IT WAS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS GIVEN.

  Patient problems: Pain

  MAUDE report 10449791 ↗
• InjuryOct 11, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT THE PATIENTS IPG WAS NO LONGER WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Code Available

  MAUDE report 9180151 ↗
• InjuryJul 22, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN OVER THE IPG SITE. IT WAS ALSO MENTIONED THAT THE SCS WAS NOT PROVIDING ADEQUATE RELIEF AND WAS CAUSING INCREASED PAIN AND JOLTING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

  Patient problems: No Code Available; Pain; Undesired Nerve Stimulation

  MAUDE report 8814325 ↗
• InjuryJun 19, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT AS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8713866 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

  Patient problems: No Code Available

  MAUDE report 8705571 ↗
• InjuryJun 13, 2019Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND IPG FREQUENT CHARGING. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8697465 ↗

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-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-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-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-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.