Precision™ SC-9218-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729888734), received between Jul 20, 2017 and Jan 28, 2026 — classified as 1 death, 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (13 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) ADAPTER HAD HIGH IMPEDANCE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ADAPTERS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203590 ↗
• InjuryDec 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE SPINAL CORD STIMULATION (SCS) AS A RESULT OF HIGH IMPEDANCES DISPLAYED ON THE LEAD. DEVICE PROGRAMMING OPTIMIZATION WAS ATTEMPTED; HOWEVER, THE ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE, WHERE TROUBLESHOOTING FOUND THERE WAS AN UNSTABLE CONNECTION BETWEEN THE LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC LEAD. THEREFORE, THE LEAD ADAPTER AND NON-BOSTON SCIENTIFIC LEAD WERE EXPLANTED, AND A NEW BOSTON SCIENTIFIC LEAD WAS IMPLANTED. POSTOPERATIVELY, THE PATIENT WAS CONTENT AND RECEIVED FULL STIMULATION COVERAGE. THE DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE CUSTOMER.

  Patient problems: Pain

  MAUDE report 23813490 ↗
• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881497 ↗
• InjuryAug 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) ADAPTERS OF THE PATIENT HAD IMPEDANCE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. 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 22819815 ↗
• InjuryAug 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790202 ↗
• InjuryJul 10, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEAD. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469952 ↗
• InjuryJul 10, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEAD. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469951 ↗
• InjuryJan 27, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO INADEQUATE STIMULATION AS WAS NOT GETTING SIGNIFICANT RELIEF, THE PATIENT OPTED TO USE A NON BSC DEVICE INSTEAD. 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

  MAUDE report 21239977 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS' MIDLINE INCISION HAD OPENED AND ITS LOOKS LIKE PATIENTS BODY WAS REJECTING THE SPINAL CORD STIMULATOR LEAD. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD WAS COMING OUT TO THE SKIN SURFACE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 20906995 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458088 ↗
• InjurySep 26, 2024High impedance; Overheating of Device; Wireless Communication Problem; High impedance; Overheating of Device; Wireless Communication Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN IMPLANT PROCEDURE; HIGH IMPEDANCES WERE DISCOVERED AND STIMULATION WAS NOT PROVIDING ADEQUATE RELIEF. AFTER THE PROCEDURE, THE PHYSICIAN ASSESSED THAT THE COMPETITORS LEAD OR THE BOSTON SCIENTIFIC ADAPTER MIGHT BE THE CAUSE OF THE HIGH IMPEDANCE READINGS AND THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO HAVE THEM REMOVED AND IMPLANT BOSTON SCIENTIFIC LEADS INSTEAD. DURING THIS REVISION PROCEDURE, THERE WAS COMMUNICATION DIFFICULTY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE REMOTE CONTROL AND CLINICIAN PROGRAMMER (CP). THEREFORE, THE PHYSICIAN REPLACED THE IPG INTRAOPERATIVELY. ADDITIONALLY, IT WAS NOTED THAT THE REPLACED IPG FELT OVERHEATED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE ADAPTER WILL NOT BE RETURNED AS IT WAS DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED THAT CONFIRMED THE USE OF ELECTROCAUTERY DURING THE REVISION PROCEDURE.

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

  MAUDE report 20316454 ↗
• InjuryAug 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) M8 ADAPTER WAS SHOWING HIGH IMPEDANCE DURING AN IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE. THE PATIENTS ADAPTER WAS REPLACED, AND ALL IMPEDANCES WERE CLEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061327 ↗
• InjuryMar 6, 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) PATIENT EXPERIENCED A CYST FORMATION AT THE ADAPTER SITE. THE PHYSICIAN ASSESSED THAT THE ADAPTERS WERE RUBBING TOGETHER AND CAUSING IRRITATION RESULTING IN THE CYST FORMATION. THEREFORE, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO INVESTIGATE THE SITE AND A CULTURE WAS TAKEN. CULTURE RESULTS REVEALED A LOW-GRADE STAPHYLOCOCCAL GROWTH. THE PATIENT WAS RECOVERING WITH NO COMPLICATIONS POST OPERATIVELY.

  Patient problems: Bacterial Infection; Insufficient Information; Skin Inflammation/ Irritation

  MAUDE report 18853238 ↗
• InjuryNov 3, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HAVING HIGH IMPEDANCES ON THE LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067287 ↗
• InjuryOct 19, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD ADJUSTMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969555 ↗
• InjurySep 15, 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 UNDESIRED SENSATIONS IN THEIR HEAD RELATED TO STIMULATION. THE PATIENT UNDERWENT A PROCEDURE (REPORTED IN MFR# 3006630150-2023-01540) TO REVISE THE SPINAL CORD STIMULATION (SCS) SYSTEM IN RESPONSE TO THE UNDESIRED SENSATIONS. HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE THESE SENSATIONS POSTOPERATIVELY, AND UNDERWENT A SECOND PROCEDURE. PRIOR TO THE SECOND PROCEDURE THE PHYSICIAN WAS UNABLE TO CONNECT TO THE IMPLANTABLE PULSE GENERATOR (IPG) SINCE THE DEVICE HAD BEEN OFF SINCE THE PREVIOUS PROCEDURE; PRE-OPERATIVE CHARGING EFFORTS IN THE HOSPITAL WERE UNSUCCESSFUL. THEREFORE, THE IPG AND NON-BOSTON SCIENTIFIC LEADS WERE REPLACED, AND THE LEAD ADAPTERS WERE REMOVED. THE PATIENT DID WELL POSTOPERATIVELY AND RECEIVED ADEQUATE COVERAGE. PHYSICAL ANALYSIS OF THE DEVICES COULD NOT BE COMPLETED IN OUR LABORATORY, AS THEY WERE DISCARDED BY THE FACILITY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 17761363 ↗
• InjuryJul 5, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. DURING THE LEAD REPLACEMENT PROCEDURE, THE PHYSICIAN COULD NOT PLACE THE LEAD DUE TO SCARING. ALL DEVICE COMPONENTS WERE EXPLANTED AND DISCARDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Scar Tissue

  MAUDE report 17254542 ↗
• InjuryMar 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THE PERIPHERAL NERVE STIMULATION (PNS) PATIENT EXPERIENCED OCCASIONAL DISCOMFORT FOR SHORT PERIODS OF TIME AT THE LOCATION OF THE LEADS. THE PATIENT UNDERWENT AN EXPLORATORY PROCEDURE TO HELP DETERMINE THE SOURCE OF THE SENSATION, AND CORROSION WAS DISCOVERED ON SEVERAL OF THE NON-BOSTON SCIENTIFIC LEAD CONTACTS INSIDE THE ADAPTORS. IN ORDER TO CLEAN THE LEADS, THE ADAPTORS WERE DISASSEMBLED AND REPLACED. THE PATIENT DID WELL POSTOPERATIVELY. THE ADAPTORS WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE FACILITY.

  Patient problems: Discomfort

  MAUDE report 16613503 ↗
• MalfunctionAug 26, 2022Fracture; Inappropriate/Inadequate Shock/Stimulation; Fracture; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION DUE TO MICROFRACTURE FROM THE LEADS WHICH WAS CONFIRMED VIA X-RAY. IT WAS NOTED THAT THE PATIENT HAS A NON-BOSTON SCIENTIFIC LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Undesired Nerve Stimulation

  MAUDE report 15305650 ↗
• InjuryAug 10, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE ADAPTERS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304454 ↗
• InjuryJun 3, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE ON THE LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE ADAPTORS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 10116493 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENTS M8 ADAPTER WAS STICKING OUT THROUGH THE SKIN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE WHEREIN THE INCISION WAS OPENED AND TUCKED THE M8 ADAPTER BEHIND THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Erosion; No Code Available

  MAUDE report 8826770 ↗
• InjuryJun 11, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENTS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8687564 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENTS LEADS WERE TEARING THE FLESH WHEN BENDING OVER. IT WAS NOTED THAT THE LEADS WERE CAUSING PAIN BEING IN THE SURFACE OF THE SKIN. IT WAS UNKNOWN IF THERE WAS SKIN BREAKAGE.

  Patient problems: Erosion; Pain

  MAUDE report 8191984 ↗
• InjuryJul 26, 2018Material Integrity Problem; Material Integrity Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUSPECTED LEAD EXTENSION FAILURE. THE PATIENT UNDERWENT AN SCS SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Information

  MAUDE report 7724841 ↗

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-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-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-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-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-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.