Precision™ SC-1112Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729837138), received between Jun 16, 2017 and Oct 21, 2025 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (16 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 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 REVISED 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 23350860 ↗
• InjuryMar 15, 2024Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF AND CHARGING ISSUES. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE WHEREIN AN MRI COMPATIBLE DEVICE WAS IMPLANTED. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 18918223 ↗
• InjuryMar 8, 2024Delayed Charge Time; Charging Problem; Delayed Charge Time; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IPG FOR AN EXTENDED PERIOD OF TIME. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED, AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865668 ↗
• InjuryDec 20, 2023Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATIONAL PAIN AND INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT HAD TO CHARGE THE IPG FREQUENTLY. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Burning Sensation; Pain

  MAUDE report 18362572 ↗
• InjurySep 12, 2023Unexpected Therapeutic Results; Charging Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION, AND HAD TO CHARGE THEIR SPINAL CORD STIMULATOR (SCS) IMPLANTABLE PULSE GENERATOR (IPG) MORE FREQUENTLY. REPROGRAMMING WAS ATTEMPTED, HOWEVER IT WAS NOT ABLE TO RESOLVE THE LACK OF THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED, AND IS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 17733151 ↗
• InjuryAug 18, 2023Delayed Charge Time; Charging Problem; Delayed Charge Time; Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING AND INCREASED CHARGING FREQUENCY OF THEIR IMPLANTABLE PULSE GENERATOR (IPG). ATTEMPTS TO RE-EDUCATE THE PATIENT ON CHARGING TECHNIQUES DID NOT RESOLVE THE ISSUE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED AND DID WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574400 ↗
• InjuryJul 18, 2023Charging 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 EXPERIENCED DIFFICULTY CHARGING AND UNDERWENT A PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE PATIENT IS DOING WELL POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347532 ↗
• InjuryJan 20, 2023Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED IPG WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213460 ↗
• InjuryJan 16, 2023Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT HAD BEEN USING HIGH RATE STIMULATION SETTINGS. THE PATIENT WAS RE-EDUCATED ON PROPER CHARGING TECHNIQUES AND A DIFFERENT CHARGER WAS USED TO CHARGE THE IPG HOWEVER NEITHER OF THESE TROUBLESHOOTING ATTEMPTS RESOLVED THE CHARGING ISSUE. THEREFORE, THE PATIENT UNDERWENT A SUCCESSFUL IPG REPLACEMENT PROCEDURE. THE ORIGINAL LEADS REMAINED IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174422 ↗
• InjuryAug 22, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE OLD IPG WAS REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) CAPABLE ONE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15265114 ↗
• InjuryNov 19, 2021Unexpected Therapeutic Results; Charging Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND CHARGING DIFFICULTIES OF THEIR IMPLANTABLE PULSE GENERATOR (IPG). THE PHYSICIAN ASSESSED THAT THE IPG HAD TILTED AND THE PATIENT UNDERWENT A REVISION PROCEDURE. THE PATIENT IS DOING WELL POST-OP.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 12841482 ↗
• InjuryAug 11, 2021Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR IPG WHEREIN REQUIRING FREQUENT CHARGING UP TO 3 TO 4 HOURS A DAY WHILE UNSUCCESSFULLY ACHIEVING A FULL CHARGE. THE IMPEDANCES WERE MEASURED AND ALL CONTACTS WERE FUNCTIONING AS NORMAL. THERE WERE NO HARDWARE OR SOFTWARE ISSUES SUSPECTED WITH THE IPG BASED ON A REVIEW OF THE PATIENTS HIGH FREQUENCY PROGRAMMING USAGE. THE PATIENTS CHARGER WAS REPLACED THREE TIMES OVER THE COURSE OF A 6 MONTH PERIOD, HOWEVER THE ISSUE CONTINUED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310500 ↗
• InjuryJun 28, 2021Unexpected Therapeutic Results; Charging Problem; Unexpected Therapeutic Results; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND WAS HAVING DIFFICULTY CHARGING THE IPG WHICH RESULTED TO THE IPG BEING NON FUNCTIONAL. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. EXPLANTED IPG WILL NOT BE RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12074178 ↗
• InjuryMay 14, 2021Overheating of Device; Charging Problem; Overheating of Device; Charging Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED MORE FREQUENT CHARGING FOR EXTENDED PERIODS OF TIME RESULTING IN OVERHEATING AND SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PHYSICIAN ASSESSED THAT THE IPG MAY BE COMING TO THE END OF LIFE AS THE PATIENT HAD BEEN RUNNING HIGH RATE PROGRAMS FOR MOST OF THE LIFE OF THE DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE DEVICE, AND DID WELL POST-OPERATIVELY.

  Patient problems: Swelling/ Edema

  MAUDE report 11829447 ↗
• InjuryFeb 10, 2021Unexpected Therapeutic Results; Wireless Communication Problem; Unexpected Therapeutic Results; Wireless Communication Problem

  IT WAS REPORTED THAT TWO DAYS FOLLOWING HIP SURGERY THE PATIENT COULD NOT FEEL STIMULATION AND THE REMOTE COULD NOT COMMUNICATE WITH THE IPG. THE PHYSICIAN SUSPECTED ELECTROCAUTERY WAS USED DURING THE HIP SURGERY, BUT WAS NOT ABLE TO CONFIRM. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE IPG AND THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312117 ↗
• InjuryNov 17, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING CHARGING DIFFICULTIES. THE UNDERWENT AN IPG EXPLANT PROCEDURE. EXPLANTED IPG WILL NOT BE RETURNED.

  Patient problems: No Code Available

  MAUDE report 10850348 ↗
• InjurySep 13, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS CHARGING THE IPG FREQUENTLY. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 10526419 ↗
• InjurySep 9, 2020Overheating of Device; Defective Device; Charging Problem; Overheating of Device; Defective Device; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT CHARGING OF THE IPG. IT WAS ALSO NOTED THAT THE PATIENTS IPG WAS GETTING HOT AND WAS NO LONGER OPERABLE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED IPG WAS NOT RETURNED.

  Patient problems: No Code Available

  MAUDE report 10512397 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED EFFACEMENT OF THE IPG AND MAY HAVE HAD AN UNDERLYING STAPH INFECTION. THE PATIENT UNDERWENT AND IPG EXPLANT PROCEDURE.

  Patient problems: No Code Available; Pocket Erosion; Staphylococcus Aureus; Swelling

  MAUDE report 8978254 ↗
• InjuryApr 16, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8519357 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 7803261 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIZZINESS, FEVER AND A SWOLLEN FACE. THE PHYSICIAN ASSESSED THAT THE PATIENT HAD A NON-DEVICE RELATED INFECTION AND SEPSIS IN THE BLOOD. THE PATIENT WAS HOSPITALIZED AND WAS ASSESSED TO BE IN SERIOUS CONDITION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND AN EXPLANT OF THE ENTIRE SYSTEM WAS CONDUCTED.

  Patient problems: Bacterial Infection; Fever; Sepsis; Swelling

  MAUDE report 7216966 ↗
• MalfunctionJan 2, 2018Telemetry Discrepancy; Telemetry Discrepancy

  A REPORT WAS RECEIVED THAT THE PATIENTS IPG WOULD NOT COMMUNICATE WITH THE REMOTE CONTROL. MULTIPLE ATTEMPTS WERE MADE TO TROUBLESHOOT, BUT WERE UNSUCCESSFUL. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7157003 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO INADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7067713 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN EVERY TIME HE TURNED THE STIMULATOR ON. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

  Patient problems: Pain

  MAUDE report 7018617 ↗

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-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-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-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-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-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.