NA SC-3138-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729760542), received between Dec 6, 2016 and Nov 25, 2025 — classified as 22 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (10 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 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 EXTENSION CONNECTION SITE. THE PATIENT UNDERWENT A LEAD AND LEAD EXTENSION REPOSITIONING PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN USE.

  Patient problems: Discomfort

  MAUDE report 23649912 ↗
• InjurySep 11, 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 23034246 ↗
• InjuryJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR PADDLE LEAD DEMONSTRATED IMPEDANCE CONCERNS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PADDLE LEAD AND WAS ONLY ABLE TO DISCONNECT IT FROM THE EXTENSION. CONSEQUENTLY, ONLY THE EXTENSION COMPONENT WAS EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS REPORTED TO BE IN STABLE CONDITION POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679874 ↗
• InjuryJul 28, 2025Charging 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) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION INDICATED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO CHARGING DIFFICULTIES. ELECTROCAUTERY WAS NOT UTILIZED DURING THE INTERVENTION. THE PATIENT IS CURRENTLY RECOVERING WELL IN THE POSTOPERATIVE PERIOD. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE HAS BEEN RETAINED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628369 ↗
• InjuryJun 30, 2025High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO A DAMAGED LEAD EXTENSION THAT RESULTED IN A LEAD IMPEDANCE. THE PATIENT UNDERWENT LEAD EXTENSION REPLACEMENT AND LEAD EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 22364409 ↗
• InjuryJan 8, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 21099341 ↗
• InjuryNov 7, 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 AT THE SITE WHERE THE EXTENSIONS WERE LOCATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 18089236 ↗
• InjuryAug 29, 2023Adverse 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 STARTED EXPERIENCING SIGNS OF INFECTIONS AT THE SURGICAL SITE. THE PATIENT HAD SYMPTOMS OF DISCOMFORT AND DISCHARGE. IT WAS NOTED THAT A CULTURE WAS NO TAKEN AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE PHYSICIAN STATED THAT THE INFECTION WAS PROCEDURE-RELATED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO CLEAN OUT THE LEAD EXTENSION AND BURY IT DEEPER. NO DEVICES WERE EXPLANTED OR REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; Fluid Discharge; Unspecified Infection

  MAUDE report 17647625 ↗
• InjuryJul 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL WITH GOOD COVERAGE POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 17272896 ↗
• InjurySep 20, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO A CHANGE OF THE IMPEDANCE LEVEL THAT WAS CAUSED BY PRESSING ON THE EXTENSIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED AND WAS BURIED DEEPER IN THE POCKET. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15454166 ↗
• InjuryMar 24, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A TANGLED LEAD EXTENSION CAUSING DISCOMFORT. THE PATIENT UNDERWENT A REVISION WHEREIN THE EXTENSION WAS EXPLANTED AND THE IPG WAS REPOSITIONED.

  Patient problems: Discomfort

  MAUDE report 13890604 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRIAL PERM IMPLANT PROCEDURE THE PATIENT WAS HAVING AN INFECTION. SYMPTOM OF OPEN WOUND WAS NOTED. THE INFECTION WAS NOT DEVICE RELATED BUT PHYSICIAN FELT IT MAY SPREAD TO DEVICE AND THE PHYSICIAN WAS UNAWARE THAT THE PROCEDURE CONTRIBUTED TO INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS EXPLANTED AND THE TAIL OF THE LEADS WERE CUT LEAVING THE ELECTRODE PORTION IN PLACE TO KEEP OPEN FOR REVISION. THE PATIENT WAS SENT TO REHABILITATION FACILITY FOR RECOVERY AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE SENT TO LABORATORY FOR CULTURE.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 12687674 ↗
• InjuryJul 1, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL PERCUTANEOUS LEAD REVISIONS FOLLOWING LEAD MIGRATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED REGARDING THE PREVIOUS REVISIONS. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103645 ↗
• InjuryJun 24, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD WIRES MIGRATED OUT OF THE EPIDURAL SPACE AND WAS WRAPPED AROUND THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED AND THE OLD LEADS WERE REPLACED WITH A PADDLE LEAD. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063960 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INFECTION NEAR THE TUNNELING OF THE LEADS. IT WAS ALSO NOTED THAT A CYST APPEARED ON TOP OF PATIENTS SHOULDER WHERE LEADS WERE TUNNELED AND THE INCISION STITCH HOLDING THE PERIPHERAL LEAD UNDER THE SKIN WAS TRYING TO SPIT OUT. THE PHYSICIAN BELIEVED THAT THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN REMOVED AND REPLACED THE STITCH WITH A DIFFERENT MATERIAL SUTURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE REMAINED IMPLANTED.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 11329770 ↗
• InjuryAug 25, 2020High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES FOUND IN THE CONTACTS OF THE LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED. THE EXPLANTED LEAD EXTENSIONS WERE NOT RETURNED.

  Patient problems: No Code Available

  MAUDE report 10451889 ↗
• MalfunctionJun 8, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD EXTENSIONS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPROGRAMMED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE HIGH IMPEDANCES WERE CLEARED. THE EXPLANTED DEVICES WILL BE RETURNED.

  Patient problems: No Code Available

  MAUDE report 10131506 ↗
• MalfunctionOct 21, 2019Fracture; Fracture

  A REPORT WAS RECEIVED THAT THE PATIENTS LEAD EXTENSION WAS FRACTURED. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 9214226 ↗
• InjurySep 19, 2019High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 9092881 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION DURING PERM TRIAL. THE PATIENT WAS GIVEN ORAL AND INJECTION ANTIBIOTICS. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY.

  Patient problems: Unspecified Infection

  MAUDE report 8570145 ↗
• MalfunctionMar 25, 2019Fracture; Migration; Fracture; Migration

  A REPORT WAS RECEIVED THAT DURING AN EXPLANT PROCEDURE, THE LEAD EXTENSION WAS SEVERED WHICH LEAVES A SHARP TIP. IT WAS ALSO REPORTED THAT THE LEAD EXTENSION HAS MIGRATED AND ERUPTED THROUGH PATIENTS SKIN.

  Patient problems: Complaint, Ill-Defined; No Known Impact Or Consequence To Patient

  MAUDE report 8450234 ↗
• InjuryAug 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A REPORT WAS RECEIVED THAT A LEAD EXTENSION WAS RETURNED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Information

  MAUDE report 7760297 ↗
• MalfunctionJun 28, 2018High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT COULD NOT GET ADEQUATE COVERAGE AND HAS NO PAIN RELIEF. IT WAS NOTED THAT THE LEADS SHOWED HIGH IMPEDANCES DURING REPROGRAMMING. THE PATIENT UNDERWENT A REVISION PROCEDURE. DURING THE REVISION PROCEDURE, IT WAS DETERMINED THAT IT WAS THE LEAD EXTENSIONS WHERE CAUSING THE LEADS TO SHOWED HIGH IMPEDANCES. THE PATIENT'S LEAD EXTENSIONS WERE REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS ABLE TO GET THE STIMULATION BACK AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7645447 ↗
• InjuryMar 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 MIDLINE INCISION SITE THAT WAS AGGRAVATED WHEN THE STIMULATION WAS TURNED HIGH. SWELLING WAS ALSO NOTED AT THE INCISION SITE. THE PHYSICIAN BELIEVED THAT THE SYMPTOMS WERE DUE TO THE EXTENSION LEADS. THE PATIENT WILL UNDERGO A LEAD EXTENSION REVISION PROCEDURE.

  Patient problems: Edema; Pain

  MAUDE report 7360537 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT'S LEAD EXTENSIONS POPPED OUT OF THE SKIN. IT WAS ALSO REPORTED THAT ACTUAL SKIN BREAKAGE WAS CONFIRMED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE EXPLANTED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Skin Erosion

  MAUDE report 6917240 ↗

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-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-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-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.