NA SC-4108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729821533), received between May 2, 2017 and Aug 6, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

21 other recalls cover devices cleared under the same FDA submission (P030017, P150031); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Nonstandard Device

  It was reported that during an unknown procedure, they had trouble connecting the cables together.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151799 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD A SMALL SKIN BLISTER AT THE TRIAL OR CABLE SITE UPON REMOVING THE SPINAL CORD STIMULATOR TRIAL. THE PHYSICIAN BELIEVED THAT THE BLISTER WAS A RESULT FROM THE FRICTION APPLIED FROM THE OR BOX BANDAGED TO THE PATIENTS SKIN ON A NORMAL DAY TO DAY ACTIONS DURING THE TRIAL.

  Patient problems: No Code Available; Skin Irritation

  MAUDE report 9681251 ↗
• InjuryFeb 9, 2018Adverse 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 PRODUCT WAS RETURNED FOR AN UNKNOWN REASON.

  Patient problems: No Information

  MAUDE report 7261005 ↗
• InjuryMay 2, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  A REPORT WAS RECEIVED THAT THE TRIAL PATIENT FELT A HIGH BURNING SENSATION ON THE LEAD EXTENSION AND THE EXTERNAL TRIAL STIMULATOR (ETS), AND THEY FELT HOT. IT WAS NOTED THAT THE ETS WAS INSIDE THE PATIENT¿S BELT. THE PATIENT IMMEDIATELY TURNED THE STIMULATION OFF. IT WAS REPORTED THAT THE OR CABLE HAD A BLACK MARK ON ONE OF THE EXTENSIONS SIMILAR TO A SCORCH.

  Patient problems: Burning Sensation

  MAUDE report 6539156 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017, P150031. 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-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• 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-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• 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-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-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the
• 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-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-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-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-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

…and 6 more.