Precision™ SC-9208-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729893271), received between Aug 29, 2019 and Sep 29, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “High impedance” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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 replaced device is unknown. Additional information has been requested; and will be provided as it becomes available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932060 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796868 ↗
• InjuryAug 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383822 ↗
• InjuryJul 21, 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 CURRENT LOCATION OF THE REPLACED DEVICE IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899227 ↗
• InjuryJun 3, 2026High impedance

  It was reported that the patient's leads had high impedances. The patient had an injection shot recently. It is currently unknown if this was related to their Spinal Cord Stimulator.Additional information was received indicating that the injection was not related to their SCS. The physician was planning a possible SCS revision procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385241 ↗
• InjuryJun 6, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES NOTED ON NON-BSC LEADS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE NON-BSC LEADS WERE REPLACED WITH TWO AVISTA LEADS, AND THE ADAPTERS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY, AND THE EXPLANTED ADAPTERS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22161538 ↗
• InjuryMar 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT'S DURING AN ELECTIVE IMPLANTABLE PULSE GENERATOR (IPG) PROCEDURE FOR A SYSTEM UPGRADE AND MAGNETIC RESONANCE IMAGING (MRI) ACCESS, HIGH IMPEDANCE READINGS WERE DISCOVERED ON THE ADAPTERS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE ADAPTERS AND IPG WERE EXPLANTED. PATIENT IS DOING WELL POST OPERATIVELY WITH GOOD COVERAGE. THE EXPLANTED DEVICES WILL NOT BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722377 ↗
• InjuryMar 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701357 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. IT WAS NOTED THAT THE LEADS HAD MOVED IN FRONT OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE MOVED BACK BEHIND THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICES REMAIN IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 21400003 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) LEAD REVISION PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257990 ↗
• InjuryJul 18, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON THE LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY PREFERENCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17343129 ↗
• InjuryMar 30, 2023High impedance; Battery Problem; High impedance; Battery Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF COVERAGE DUE TO S8 ADAPTERS HAD HIGH IMPEDANCES. IT WAS ALSO MENTIONED THE IPG HADE REACH END OF BATTERY LIFE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE ADAPTERS WHERE EXPLANTED AND A NEW IPG WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 16642157 ↗
• InjurySep 1, 2022Off-Label Use; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Off-Label Use; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH A COMPETITORS LEADS AND BOSTON SCIENTIFIC ADAPTORS, EXPERIENCED MILD ELECTRIC SHOCKS THROUGHOUT THE ENTIRE BODY, AND EXPERIENCED INADEQUATE STIMULATION. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE, HOWEVER PRIOR TO THE SURGERY, THE PHYSICIAN COULD TRIGGER THE ELECTRIC SHOCKS BY PRESSING ON THE HEADER OF THE IMPLANTABLE PULSE GENERATOR, IPG, WHERE THE ADAPTOR CABLES COME OUT. AFTER THE IPG POCKET WAS OPENED, THE PHYSICIAN COULD NO LONGER TRIGGER THE SHOCKS ANYMORE. NEVERTHELESS, THE PHYSICIAN DECIDED TO REPLACE BOTH ADAPTORS WITH NEW ONES. THE PATIENT WAS DOING FINE POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15341755 ↗
• InjurySep 25, 2020Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE COVERAGE. THE PHYSICIAN EXPLANTED THE ADAPTERS AND THE EXPLANTED ADAPTERS WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 10586090 ↗
• InjuryAug 29, 2019Failure to Charge; High impedance; Failure to Charge; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT WAS IMPLANTED WITH A COMPETITORS LEAD AND A BSN IPG AND LEAD ADAPTOR. A SURGERY WAS PERFORMED TO CONVERT THE PATIENT TO NEWER TECHNOLOGY AND AFTER DOING SO IMPEDANCES WERE GOOD ON ALL CONTACTS. DURING POST OPERATIVE PROGRAMMING MULTIPLE HIGH IMPEDANCES WERE NOTED. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM AS AN EMERGENCY AND THE BATTERY SITE WAS OPENED AGAIN. THE LEADS WERE STRAIGHTENED OUT AND A NEW ADAPTOR WAS TRIED HOWEVER THE IMPEDANCE PROBLEM DID NOT RESOLVE. THE LEADS WERE THEN CONNECTED DIRECTLY TO THE IPG AND ONCE AGAIN THERE WAS NO CHANGE. THE PHYSICIAN EXAMINED THE TAILS OF THE COMPETITORS LEAD AND BELIEVED THERE WAS SOME DISCOLORATION AND AIR BUBBLES. HE ASSESSED THAT AS THE LEAD HAD BEEN IN A CERTAIN POSITION FOR SIX YEARS WHEN THEY STRAIGHTENED IT OUT A MICROSCOPIC TEAR OCCURRED ALLOWING FLUID TO GET UNDER THE SILICONE CAUSING AN IMPEDANCE BUILDUP. THEY WERE UNABLE TO RESOLVE THIS ISSUE SO THE PHYSICIAN CHOSE TO CLOSE THE PATIENT AND PERFORM ANOTHER SURGERY THE FOLLOWING WEEK TO REPLACE THE LEAD. DURING THAT WEEK THE IPG WAS CONNECTED AND WAS FULLY CHARGED. THIS WAS LEFT INSITU FOR THE WEEK CONNECTED TO THE BSN LEAD ADA

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8946444 ↗

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-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-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-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-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.