Precision™ Montage™ MRI SC-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,316 adverse event reports that list this exact device (DI 08714729905943), received between Dec 9, 2016 and Sep 30, 2026 — classified as 22 deaths, 4,258 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (1,405 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 4,316 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Charging Problem

  It was reported that the patient was experiencing pain at the IPG and the patient was unable to charge the IPG. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) leads were replaced with an MRI compatible device. The patient was doing well postoperatively and the explanted devices were retained by the medical facility and will not be returned.

  Patient problems: Implant Pain

  MAUDE report 50941952 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934469 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932631 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain at the Implantable Pulse Generator (IPG) site. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: Implant Pain

  MAUDE report 50929785 ↗
• InjurySep 28, 2026Charging Problem

  It was reported that the spinal cord stimulation (SCS) patient underwent an implantable pulse generator (IPG) replacement due to difficulty charging. Reeducation was attempted. No patient complications were reported. The patient was reported to be alert and oriented postoperatively with no complications. The explanted device was not returned for analysis due to hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920305 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away. The cause of death is not believed to be related to stimulation; however, it remains unconfirmed. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918191 ↗
• InjurySep 28, 2026Charging Problem

  It was reported that the patients Implantable Pulse Generator (IPG) was not holding a charge. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG will not be returned per hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910677 ↗
• InjurySep 28, 2026Charging Problem

  It was reported that the patients Implantable Pulse Generator (IPG) was not holding a charge and the patient had difficulty charging it. The patient underwent an IPG replacement procedure and was doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910625 ↗
• MalfunctionSep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50905892 ↗
• InjurySep 25, 2026Wireless Communication Problem

  It was reported that the patient was experiencing inability to connect to Implantable Pulse Generator (IPG). The patient underwent Implantable Pulse Generator (IPG) replacement procedure. Patient was doing well postoperatively. Unable to return product due to hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898542 ↗
• InjurySep 25, 2026Charging Problem

  It was reported that this Spinal Cord Stimulation (SCS) patient experienced charging difficulties with his implantable pulse generator (IPG), to address this the patient underwent a revision procedure where in the IPG was explanted and replace. Post operatively the patient is doing great. In accordance with facility policy the explanted device was disposed of and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897784 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results

  Patient problems: Burning Sensation; Pain

  MAUDE report 50892400 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an Implantable Pulse Generator (IPG) replacement procedure due to an unknown reason. The patient was doing well postoperatively. Explanted device was not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878503 ↗
• InjurySep 23, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876370 ↗
• InjurySep 23, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862960 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Delayed Charge Time; Charging Problem

  It was reported that the patient was having difficulty charging the Implantable Pulse Generator (IPG) and the patient's spinal cord stimulator (SCS) paddle lead had migrated. It was also stated that the patient was not getting the right coverage despite device optimization. The patient underwent a procedure wherein the IPG and lead were explanted.

  Patient problems: Pain

  MAUDE report 50851700 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing discomfort. The patient underwent revision procedure and was doing well postoperatively. Explanted device was retained.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50851444 ↗
• InjurySep 22, 2026Charging Problem

  It was reported that the patient was experiencing difficulty charging the Implantable Pulse Generator (IPG). The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: Weight Changes

  MAUDE report 50851443 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an unknown procedure due to an unknown reason.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851131 ↗
• InjurySep 21, 2026Adverse 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 replaced device is unknown. Details regarding this event were requested, however, the physicians office as unable to track the records of said event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844027 ↗
• InjurySep 21, 2026Charging Problem

  It was reported that the patient experienced an increased charging frequency of the Implantable Pulse Generator (IPG). The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG will not be returned per hospital policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835281 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away. The cause of death is not believed to be related to stimulation; however, it remains unconfirmed. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810853 ↗
• InjurySep 17, 2026Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate pain relief and a burning sensation all over the body, The patient was admitted to the hospital for unknown reason.

  Patient problems: Burning Sensation; Pain

  MAUDE report 50803470 ↗
• InjurySep 17, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient's implantable pulse generator (IPG) had reached End of Life. It was also stated that the patient was experiencing inadequate stimulation. After recent device optimization, the patient was getting good relief for less than two days. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was retained by the medical facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50801232 ↗
• InjurySep 17, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patients implantable pulse generator (IPG) would no longer hold a charge. The patient underwent an IPG replacement procedure. The patient was doing well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798389 ↗

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-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-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-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.