NA SC-3400-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729797838), received between Jan 9, 2017 and Dec 3, 2025 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High impedance” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 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 23711795 ↗
• InjuryDec 2, 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 23696260 ↗
• InjurySep 10, 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 23018961 ↗
• InjuryAug 28, 2023High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT ONLY HAD STIMULATION ON THE RIGHT SIDE. AFTER RUNNING AN IMPEDANCE CHECK, IT WAS DETERMINED THAT THE SPLITTERS ON THE INFINION LEADS WERE CAUSING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED, THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 17638893 ↗
• InjuryFeb 8, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS LEADS AND SPLITTERS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326749 ↗
• InjurySep 7, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 15374501 ↗
• InjuryNov 26, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS HAVING LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR REVISION PROCEDURE WHEREIN A SPLITTER WAS REPLACED AND RESOLVED FOUR OUT OF FIVE CONTACTS WITH HIGH IMPEDANCE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878143 ↗
• MalfunctionMay 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENTS SPLITTERS HAD A LOT OF FRACTURES. THE FRACTURED SPLITTERS WERE EXPLANTED AND WERE NOT RETURNED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814288 ↗
• InjuryOct 27, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. IT WAS NOTED THAT THE LIKELY SOURCE OF THE PROBLEM WAS THE SPLITTER AND THE IMPEDANCES ARE POSSIBLY OFF DUE TO POOR CONNECTIONS WITHIN THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief; No Code Available

  MAUDE report 9243438 ↗
• InjurySep 27, 2019Fracture; Unexpected Therapeutic Results; Fracture; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENTS SPLITTERS WERE FRACTURED AND THE PATIENT EXPERIENCED LOSS OF STIMULATION WITH THE LEADS. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 9127257 ↗
• InjuryMay 29, 2019High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT HAD HIGH IMPEDANCES. LOSS OF STIMULATION WAS ALSO NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: No Code Available

  MAUDE report 8650240 ↗
• InjuryMar 21, 2019High impedance; High impedance

  A REPORT WAS RECEIVED THAT THERE WERE HIGH IMPEDANCES NOTED IN THE PATIENT'S SCS SYSTEM. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE SPLITTERS WERE REPLACED. THERE WERE STILL HIGH IMPEDANCES, HOWEVER, ALL PAIN AREAS WERE COVERED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8440856 ↗
• InjuryFeb 15, 2019High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT SPLITTERS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8345611 ↗
• MalfunctionApr 27, 2018High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE SPLITTER WAS CAUSING HIGH IMPEDANCE. THE PATIENT UNDERGO AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469612 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE FOR AN UNKNOWN REASON.

  Patient problems: No Information

  MAUDE report 7046428 ↗
• InjuryNov 15, 2017Fracture; High impedance; Fracture; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD SPLITTER REPLACEMENT DUE TO SUSPECTED DAMAGE OF ONE OF THE LEAD SPLITTERS.

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

  MAUDE report 7033575 ↗
• InjuryNov 15, 2017High impedance; Defective Component; High impedance; Defective Component

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED AND THE SPLITTERS WERE EXPLANTED. DURING THE INTRAOPERATIVE TESTING, IT WAS CONFIRMED THAT THE SPLITTERS WERE KNOWN TO BE THE PROBLEM OF DEFECT. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7032958 ↗
• MalfunctionNov 8, 2017High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT ONE OF THE LEAD WAS COMPLETELY OUT DUE TO THE SPLITTER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THERE WAS MALFUNCTION SUSPECTED WITH THE SPLITTER. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7010398 ↗
• InjuryOct 10, 2017Expiration Date Error; Expiration Date Error

  A REPORT WAS RECEIVED THAT DURING PERMANENT IMPLANT PROCEDURE THE PATIENT WAS IMPLANTED WITH AN EXPIRED LEAD SPLITTERS. THE BSN REPRESENTATIVE CONFIRMED THAT IT WAS NOT EXPIRED BUT WAS USED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6938931 ↗
• MalfunctionAug 7, 2017Bent; Fracture; High impedance; Kinked; Cut In Material; Bent; Fracture; High impedance; Kinked; Cut In Material

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. THE PHYSICIAN SUSPECTED THAT THE SPLITTERS WERE CORRUPTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG, LEADS, AND CLIK ANCHOR WERE REPLACED. DURING THE EXPLANT, THE LEADS AND SPLITTERS WERE CUT AROUND THE SCAR TISSUE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6772727 ↗
• MalfunctionApr 5, 2017High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT AND LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE MOVED UP TO THE ORIGINAL LOCATION AND THE LEAD SPLITTER WAS REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6461600 ↗
• InjuryApr 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WHEREIN A LEAD WAS RETURNED FOR AN UNKNOWN REASON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6453078 ↗
• MalfunctionJan 9, 2017High impedance; Defective Device; High impedance; Defective Device

  A REPORT WAS RECEIVED THAT THE PRODUCTS WERE RETURNED AS THESE WERE DEFECTIVE. IT WAS NOTED THAT THE CONTACTS WERE OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233796 ↗
• InjuryJan 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PRODUCTS WERE RETURNED FOR AN UNKNOWN REASON.

  Patient problems: No Information

  MAUDE report 6233534 ↗

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-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-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-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.