NA SC-3138-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729760566), received between Jan 30, 2017 and Sep 11, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fracture

  It was reported that during a paddle trial, the patient accidentally cut one of the lead extensions while attempting to clean the bandage, resulting in loss of function of the extension. The patient was instructed to turn therapy off. The representative evaluated the system and adjusted the stimulation settings using the remaining functional lead. The patient subsequently underwent permanent implantation. The extensions were kept by the medical facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738141 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNSPECIFIED REASON. THE SYSTEM WAS REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582230 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE SPINAL CORD STIMULATION (SCS) LEAD EXTENSIONS RUNNING DOWN THE PATIENTS BACK WERE REPOSITIONED. THE DEVICES REMAIN IMPLANTED. NO FURTHER INFORMATION REGARDING THIS EVENT COULD BE OBTAINED DESPITE THREE GOOD-FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD EXTENSIONS WERE REVISED DUE TO THE LEADS PRESSING AGAINST A MUSCLE, CAUSING PAIN. THERE WERE NO OTHER ISSUES WITH THE LEAD EXTENSIONS.

  Patient problems: Implant Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624783 ↗
• InjuryAug 18, 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 PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829389 ↗
• InjuryAug 15, 2025Adverse 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 SPINAL CORD STIMULATION (SCS) LEAD EXTENSION SITE. IT WAS NOTED THAT THERE WAS VISIBLE LIQUID AT THE EXTENSION SITE. THE LEAD EXTENSION WAS REMOVED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS, THE AREA WAS DISINFECTED, AND THE PATIENT WAS NOTED TO HAVE RECOVERED. THE PHYSICIAN BELIEVED THE INFECTION WAS PROCEDURE AND DEVICE RELATED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22821852 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) TRIAL LEAD TESTING PERIOD, THE PATIENT DEVELOPED AN INFECTION WHERE THE LEAD EXTENSION EXITED THE SKIN. THE INFECTION CONSISTED OF FLUID DISCHARGE AT THE SITE AND LASTED SEVERAL DAYS AFTER THE EARLY REMOVAL OF THE DEVICE DUE TO THE INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, AND THE SITE WAS DISINFECTED. THE LEAD EXTENSION WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE EVENT RESOLVED, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 22810827 ↗
• InjuryJul 31, 2025Adverse 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 OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. IT WAS NOTED THAT THERE WERE SECRETIONS FROM THE SITE, IT WAS RED, SWOLLEN, AND THE PATIENT HAD A FEVER. THE LEAD EXTENSION WAS REMOVED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS, THE AREA WAS DISINFECTED, AND THE PATIENT IS DOING WELL. IT WAS NOTED THE INFECTION IS THOUGHT TO BE RELATED TO AN EXTERNAL NON-STERILE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF.

  Patient problems: Bacterial Infection; Erythema; Fever; Fluid Discharge; Swelling/ Edema

  MAUDE report 22683584 ↗
• MalfunctionJun 24, 2025Fracture; High impedance; Off-Label Use; Fracture; High impedance; Off-Label Use

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED PAIN ON THE LOWER PORTION LEFT PARIETAL AREA ABOVE EXTENSION HEADERS, DIFFICULTIES SPEAKING, RETURN OF THEIR TREMOR AND DYSTONIA SYMPTOMS. HIGH IMPEDANCES THAT CONTINUOUSLY FLUCTUATED WERE NOTED DURING FUNCTIONAL TESTING ON SEVERAL CONTACTS. A COMPUTED TOMOGRAPHY (CT) AND X-RAY IMAGE TAKEN EXPOSED A SLIGHTLY SHADED AREA ON ONE LEAD EXTENSION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PHYSICIAN CONFIRMED THE LEAD EXTENSION FRACTURE AS A RESULT REMOVED BOTH LEAD EXTENSIONS. THE PHYSICIAN ASSESSED THE FRACTURE WAS LIKELY CAUSED FROM CONSTANT BENDING FROM IT SLIPPING DOWN THE OCCIPUT INTO THE NECK. ANALYSIS OF THE LEAD EXTENSIONS WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Movement Disorder; Pain; Shaking/Tremors; Speech Disorder

  MAUDE report 22322025 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NIGHTMARES, AND SHE BELIEVES THEY WERE CAUSED BY THE SPINAL CORD STIMULATION (SCS). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD EXTENSION SITE IN HER BACK, AND THAT SHE REQUIRES A MAGNETIC RESONANCE IMAGING (MRI) DUE TO HAVING CANCER. THE PHYSICIAN ASSESSED THE PAIN AT THE LEAD EXTENSION SITE IS LIKELY DUE TO THE PATIENT LOSING WEIGHT AND THE EXTENSION ATTACHMENTS CAUSING IRRITATION. THE PHYSICIAN DOES NOT KNOW IF THE NIGHTMARES ARE CAUSED BY THE DEVICES OR STIMULATION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

  Patient problems: Implant Pain

  MAUDE report 21535282 ↗
• InjuryJul 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) UPGRADE, IT WAS FOUND OUT THAT TWO CONTACTS ON THE LEAD HAD HIGH IMPEDANCES. AFTER REMOVING THE EXTENSIONS AND PUTTING THE ALREADY IMPLANTED LEADS INTO THE BATTERY, MORE CONTACTS WERE SHOWING HIGH IMPEDANCES DESPITE TROUBLESHOOTING. THE PHYSICIAN OPTED TO RETAIN THE SPINAL CORD STIMULATION AS IS. REPRESENTATIVE WAS ABLE TO PROGRAM AROUND THE INVALID CONTACTS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802659 ↗
• InjuryApr 19, 2024High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEAD EXTENSION. THE PATIENT DID WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147117 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD EXTENSION SITE AS THE CONNECTION FELT CLOSE TO THE SKIN. IT WAS ASSESSED THAT THE PATIENT'S SCARRING PULLED THE LEAD EXTENSION CONNECTION TO THE SURFACE OF THE INCISION. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD EXTENSION CONNECTIONS WERE BURIED DEEPER. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 17164020 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD EXTENSIONS EXPLANT PROCEDURE FOR IPG PLACEMENT FOLLOWING THE MFR. REPORT NUMBER: 3006630150-2022-07490. DURING THE PROCEDURE THE TIP OF ONE OF THE LEAD EXTENSIONS PLASTIC CHIPS BROKE OFF IN THE SOFT TISSUE AT THE POSTERIOR FLANK POCKET AND COULD NOT BE FOUND. THE PHYSICIAN BELIEVED THAT IT WOULD HAVE CAUSED MORE DAMAGE TO THE PATIENT TO EXCAVATE FOR THIS SMALL STERILE TIP. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEAD EXTENSIONS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231407 ↗
• InjuryMar 3, 2020High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED CRAMPING IN HIS ABDOMEN BELOW THE IPG POCKET SITE WHEN STIMULATION WAS ON. REPROGRAMMING THE DEVICE WAS ATTEMPTED, BUT ADEQUATE PAIN COVERAGE COULD NOT BE ACHIEVED AS THERE WERE HIGH IMPEDANCES ON FOUR CONTACTS. PATIENT THEN UNDERWENT A REVISION PROCEDURE WHERE THE EXTENSION WAS REPLACED. PATIENT IS FINE POST-OPERATIVELY, AND ALL IMPEDANCES ARE WITHIN NORMAL LIMITS.

  Patient problems: Muscle Spasm(s); No Code Available; Undesired Nerve Stimulation

  MAUDE report 9781949 ↗
• InjuryApr 4, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE AND UNCOMFORTABLE STIMULATION DUE TO HIGH IMPEDANCES ON THE LEADS AND LEAD EXTENSIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE TWO LEAD EXTENSIONS WERE REPLACED AS THEY HAD MORE IMPEDANCES THAN THE LEADS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; Inadequate Pain Relief; No Code Available

  MAUDE report 8484895 ↗
• InjurySep 17, 2018Migration; Migration

  A REPORT WAS RECEIVED THAT THE PATIENTS EXTENSION HUB WAS VERY SUPERFICIAL AND NOT BURIED ENOUGH DEEPER. NO SKIN BREAKAGE WAS REPORTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE EXTENSION WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Erosion

  MAUDE report 7882645 ↗
• InjuryJan 31, 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 INADEQUATE STIMULATION. THE PHYSICIAN DECIDED TO EXPLANT TWO LEADS IN ORDER TO CHANGE THE PATIENTS CURRENT THERAPY STRATEGY. PER THE PHYSICIANS ASSESSMENT DEVICE MALFUNCTION IS NOT SUSPECTED. THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief; No Known Impact Or Consequence To Patient

  MAUDE report 7232001 ↗
• InjuryJan 30, 2017Break; High impedance; Migration or Expulsion of Device; Break; High impedance; Migration or Expulsion of Device

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IT WAS DISCOVERED THAT THE PATIENT'S EXTENSION WAS BROKEN AND COMPLETELY DISCONNECTED FROM THE IPG. THERE WERE EXPOSED CABLES ON THE EXTENSION. THE PATIENT'S IPG WAS ALSO FLIPPED. THE EXTENSION WAS REPLACED AND THE PATIENT'S IPG WAS REVISED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6287197 ↗

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-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-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-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-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-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.