Precision Spectra ™ SC-1132Recalls & reported problems

Summary

The FDA's MAUDE database contains 11,269 adverse event reports that list this exact device (DI 08714729821526), received between May 21, 2014 and Sep 30, 2026 — classified as 53 deaths, 10,914 injuries, 302 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (4,489 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 11,269 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954807 ↗
• InjurySep 30, 2026Nonstandard Device; Unexpected Therapeutic Results; Charging Problem

  Patient problems: Pain

  MAUDE report 50947455 ↗
• InjurySep 29, 2026Power Problem; Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941035 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results; Battery Problem

  It was reported that the patient was experiencing loss of stimulation. It was also noted that the patients implantable pulse generator (IPG) was nearing end of battery life. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was retained by customer per facility policy.

  Patient problems: Pain

  MAUDE report 50933398 ↗
• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Burning Sensation; Discomfort; Implant Pain; Inappropriate Device Stimulation of Tissue; Swelling/ Edema

  MAUDE report 50926478 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924197 ↗
• InjurySep 28, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915667 ↗
• InjurySep 25, 2026Charging Problem; Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903744 ↗
• InjurySep 25, 2026Battery Problem; Charging Problem; Wireless Communication Problem

  It was reported that the patient had difficulty charging the implantable pulse generator (IPG). It was also noted that the patient feels a tingle sensation that is much stronger that her normal. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was discarded and will not be returned.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50899033 ↗
• InjurySep 25, 2026Unexpected Therapeutic Results

  It was reported that the patient was experiencing inadequate stimulation. It was also stated that the patient's lead placement was not ideal for the patient's pain pattern. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) paddle lead were explanted. The patient was doing well postoperatively and the explanted devices were retained by the medical facility and will not be returned.

  Patient problems: Pain

  MAUDE report 50897880 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) patient underwent an explant procedure due to implantable pulse generator (IPG) becoming nonfunctional. Post operatively the patient is doing well. In accordance with facility policy the explanted device was retained and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897596 ↗
• InjurySep 24, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient was unable to receive therapy due to difficulty charging the Implantable Pulse Generator (IPG). The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was discarded per hospital policy.

  Patient problems: Pain

  MAUDE report 50877572 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869254 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an explant due to an infection from another procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50867936 ↗
• InjurySep 22, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862907 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Charging Problem

  It was reported that the patient's implantable pulse generator (IPG) was no longer taking a charge and was not providing inadequate relied. The patient's leg pain had gotten worse with posture and certain movements. The patient describes the pain as burning aching shooting pain near low back radiating down the legs. The patient was taking extra strength Tylenol and Tizanidine with pain relief.

  Patient problems: Pain

  MAUDE report 50850164 ↗
• 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. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847555 ↗
• InjurySep 21, 2026Charging Problem

  It was reported that this Spinal Cord Stimulation (SCS) patient has been experiencing charging difficulties with his implantable pulse generator (IPG), since it was no longer holding charge. To address this, the patient underwent a revision procedure where in the IPG was explanted and replaced. Post operatively, the patient is doing great. In accordance with facility policy the explanted device was disposed of and will not be returned. Electrocautery was reportedly used during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842273 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) device was explanted due to an unknown reason. The location of the replaced device is unknown. Despite good faith efforts, no further information could be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842272 ↗
• InjurySep 21, 2026Charging Problem

  It was reported that a patient with a spinal cord stimulation (SCS) device underwent replacement of the Implantable Pulse Generator (IPG) due to charging difficulties. The explanted IPG is unable to return. Following the replacement procedure, the patient recovered well postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841543 ↗
• InjurySep 21, 2026Charging Problem

  It was reported that the Spinal Cord Stimulation (SCS) device was replaced due to charging difficulties. The patient stated that the device would not maintain a charge for more than one to two days. Charging reeducation was provided. The device was retained by the facility and will not be returned for analysis. Postoperatively, the patient was reported to be doing well.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840613 ↗
• InjurySep 19, 2026Unexpected Therapeutic Results

  Patient problems: Pain

  MAUDE report 50832652 ↗
• InjurySep 18, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829368 ↗
• InjurySep 18, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829367 ↗
• InjurySep 18, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828754 ↗

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-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-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-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.