NA SC-3138-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729760559), received between Jan 19, 2017 and Mar 4, 2026 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (11 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 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 DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509924 ↗
• InjuryNov 28, 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 FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE EXPLANTED DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23674015 ↗
• InjuryAug 12, 2025High impedance; High impedance

  IT WAS NOTED THAT THE PATIENT EXPERIENCED AN INCREASE IN MIGRAINES. THE PHYSICIAN DOES NOT FEEL THE MIGRAINES ARE DEVICE OR PROCEDURE RELATED. THE PATIENTS SYSTEM WAS OPTIMIZED HOWEVER THE ISSUE PERSISTED. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE IN WHICH IT WAS DETERMINED THAT ONE OF THE PATIENTS LEAD EXTENSIONS DISPLAYED HIGH IMPEDANCES. THE PHYSICIAN DECIDED TO REPLACE THE LEAD EXTENSION AND RECHECK IMPEDANCES AND SUBSEQUENTLY, NO IMPEDANCES WERE DETECTED. THE EXPLANTED LEAD EXTENSION WILL NOT BE RETURNED AS IT WAS DISCARDED AT THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POSTOPERATIVELY AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789922 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION (SCS) TEMPORARY TRIAL THE PATIENT EXPERIENCED PAIN AND REDNESS AT THE LEAD EXTENSION SITE. THE PHYSICIAN ASSESSED THE PATIENT HAD AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD EXTENSION WAS EXPLANTED. THE EXPLANTED LEAD EXTENSION WILL NOT BE RETURNED AS IT WAS CONTAMINATED. THE PATIENT WAS GIVEN CO-AMOXIMEPHA ANTIBIOTICS. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 22714811 ↗
• InjuryJul 31, 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 UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683109 ↗
• InjuryApr 3, 2025Use of Device Problem; Failure to Disconnect; Use of Device Problem; Failure to Disconnect

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UNDER WHICH THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA, OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM, THE LEAD EXTENSION COULD NOT BE DISCONNECTED. THE PHYSICIAN CUT THE SILICON AND REMOVED THE SCREW BLOCK, AND WAS STILL UNABLE TO DISCONNECT THE LEAD EXTENSION, INDICATING THAT THE SCREW BLOCK WAS TOO TIGHT. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770362 ↗
• InjuryMar 7, 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 UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Weight Changes

  MAUDE report 21546972 ↗
• InjuryFeb 23, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE LEAD AND LEAD EXTENSIONS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPLACED AND THE LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: Pain

  MAUDE report 21442142 ↗
• InjuryOct 25, 2024Adverse 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 LEADS WERE CAUSING THE PATIENT IRRITATION. THE PATIENT IS DOING WELL POST OPERATIVELY, THE LOCATION OF THE DEVICE IS UNKNOWN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20539089 ↗
• MalfunctionMay 10, 2023Fracture; Unexpected Therapeutic Results; Fracture; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPTS. DURING THE SURGERY, THE PHYSICIAN TOOK THE EXTENSIONS OFF THE LEADS AND FOUND OUT THAT BOTH EXTENSIONS WERE SNAPPED IN HALF AND PHYSICIAN SUSPECTED IT WAS DUE TO PATIENTS BENDING OVER TOO HARD. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 16900705 ↗
• InjuryApr 28, 2023Adverse 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 DISCOMFORT AT THE LEAD EXTENSION CONNECTION WHERE THE LEADS HAVE COME VERY CLOSE TO THE SURFACE. THE LEAD EXTENSIONS DID NOT BREAK THROUGH THE SKIN. THE PATIENT DID NOT EXPERIENCE ANY WEIGHT CHANGES. THE PHYSICIAN ASSESSED THAT THE EVENT WAS DUE TO THE WAY IN WHICH THE PATIENT SCARS FOLLOWING SURGERY. THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THE PHYSICIAN CHOSE TO REPOSITION THE IPG TO UNDER THE RIGHT ARM AND REPLACE THE TWO LEAD EXTENSIONS. THE IPG WAS REPOSITIONED DUE TO PATIENT PREFERENCE, AS SHE WAS FINDING IT HARDER TO REACH AROUND TO HER BUTTOCK TO CHARGE AS SHE AGES. THE EXPLANTED LEAD EXTENSIONS WILL NOT BE RETURNED, AS THEY WERE NOT RELEASED BY THE HOSPITAL. THE PATIENT IS DOING WELL POSTOPERATIVELY AND RECOVERING WELL.

  Patient problems: Discomfort; Erosion; Implant Pain

  MAUDE report 16837305 ↗
• MalfunctionApr 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE LEAD EXTENSIONS WAS FRACTURED WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704612 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE, A CLINICAL STUDY (A4105 INSPIRE) PATIENT EXPERIENCED DISCOMFORT AND WENT TO THE HOSPITAL DUE TO SUPPURATION OF HER SURGICAL WOUND. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PREVIOUSLY REPORTED EVENT OF THE PATIENT GOING TO THE HOSPITAL DUE TO SUPPURATION OF HER SURGICAL WOUND DID NOT OCCUR. THE PATIENT EXPERIENCED DISCOMFORT DURING THE TRIAL PROCEDURE, WHICH THE PHYSICIAN ASSESSED AS A REGULAR UNCOMFORTABLENESS OF THE TRIAL PROCEDURE. AS THERE IS NO REPORTABLE ALLEGATION AGAINST THE DEVICE ITSELF AND THERE WAS NO SERIOUS INJURY, BOSTON SCIENTIFIC NO LONGER CONSIDERS THIS TO BE A REPORTABLE EVENT.

  Patient problems: Discomfort; Purulent Discharge

  MAUDE report 16560477 ↗
• InjuryJan 16, 2023Use of Device Problem; Failure to Disconnect; Migration; Use of Device Problem; Failure to Disconnect; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS NOT POSSIBLE TO DISCONNECT THE TEMPORARY LEAD EXTENSION FROM THE LEAD. A PROCEDURE IN WHICH SURGICAL DISSECTION OF THE LEAD EXTENSION WAS PERFORMED. IT WAS ADDITIONALLY REPORTED THAT DUE TO THE EXTENDED TRIAL PERIOD, BETWEEN THE INITIAL TRIAL IMPLANT AND THE IMPLANTABLE PULSE GENERATOR (IPG), A LOT OF FIBROSIS TISSUE DEVELOPED AROUND THE ELECTRODE AND EXTENSION BODIES. IT IS NOT KNOWN WHY THERE WAS OVER A MONTH BETWEEN THE IMPLANT DATES. DURING THE PROCEDURE IT WAS DISCOVERED THAT THE LEAD EXTENSION MIGRATED, THE PHYSICIAN USED FORCE TO PULL THE LEAD EXTENSION CAUSING IT TO BREAK AND LEAVING THE PROMINENT END OF THE LEAD EXTENSION IMPLANTED. DUE TO THE FORCE USED BY THE PHYSICIAN TO PULL THE LEAD EXTENSION OUT TWO CONTACTS BECAME DISLODGED AND WERE LEFT IN THE PATIENTS' BODY. A NEW LEAD EXTENSION WAS IMPLANTED AND THE PATIENT HAS STIMULATION COVERING THE PAIN AREAS AND IS DOING WELL POST OPERATIVELY. IT WAS ADDITIONALLY REPORTED THAT THE FACILITY INADVERTENTLY PROVIDED THE WRONG DEVICE, UNRELATED TO THE SPINAL CORD STIMULATOR (SCS), FOR ANALYSIS, THEREFORE DEVICE ANALYSIS OF THE DEVICE ASSOCIATED WITH THIS ISSUE CAN NOT BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16178925 ↗
• InjurySep 16, 2022Adverse 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 WHEREIN THE EXTENSIONS WHERE EXPLANTED DUE TO IT CAUSING PAIN AROUND THE POCKET SITE. THE PATIENT WAS DOING WELL POST-OP. THE EXPLANTED DEVICE WERE DISCARDED.

  Patient problems: Implant Pain

  MAUDE report 15441887 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND THE LEAD EXTENSION WAS PALPABLE UNDER THE SKIN. THE PATIENT UNDERWENT A LEAD EXTENSION EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD EXTENSIONS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 14471905 ↗
• InjuryMay 9, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSION WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337167 ↗
• InjuryJan 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PERMANENT IMPLANT PROCEDURE, THE LEAD EXTENSION WAS OBSERVED TO BE DAMAGED AT THE SHEATHING; THE SHEATHING SKIDDED DOWN THE WIRES FROM THE CONNECTOR. THE PATIENT UNDERWENT AN EXPLANT OF THE LEAD EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252911 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEAD EXTENSION SITE PROTRUDED AND CAUSED PAIN. THERE WAS NO SKIN BREAKAGE. THE LEAD EXTENSIONS WERE EXPLANTED AND DISCARDED.

  Patient problems: Erosion; Pain

  MAUDE report 11580723 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANT SITE WERE THE EXTENSIONS WERE ADDED IN BETWEEN THE LEAD AND THE IPG SITE IN THE UPPER BUTTOCK WAS OPEN. SYMPTOM OF DRAINAGE WAS NOTED IN THE SITE. THE PATIENT WAS BANDAGED UP AGAIN AND WAS SENT TO THE EMERGENCY ROOM (ER). THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND HAD THE WOUND WASHED OUT AND CLOSED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 11478415 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD EXTENSION SITE. SYMPTOM OF REDNESS WAS NOTED. THE PHYSICIAN WAS UNSURE IF INFECTION WAS DEVICE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS.

  Patient problems: Bacterial Infection; No Code Available

  MAUDE report 10731044 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE EXTENSION POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; No Code Available

  MAUDE report 9667250 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENTS LEAD EXTENSIONS WERE CAUSING DISCOMFORT AROUND THE BELT LINE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; No Code Available

  MAUDE report 9567446 ↗
• InjuryDec 16, 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 DUE TO INFECTION AT THE LEAD EXTENSION SITES. LIQUID WAS COMING OUT FROM THE EXTENSION SITES. THE PATIENT WAS PLACED ON ANTI-BIOTICS. THE PHYSICIAN WAS UNSURE WHAT CAUSED THE INFECTION BUT SAID NOTHING HAPPENED DURING THE RECENT IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9475465 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SKIN IRRITATION OVER THE LEAD EXTENSIONS FROM THE TIME THEY WERE IMPLANTED. THE SKIN IRRITATION TURNED INTO A GRANULOMA, INCREASED IN SIZE, AND BECAME INFECTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE PATIENT IS STABLE POST OPERATIVELY.

  Patient problems: Granuloma; No Code Available; Skin Irritation; Unspecified Infection

  MAUDE report 9112022 ↗

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-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-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-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.