Precision Novi™ SC-1140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,001 adverse event reports that list this exact device (DI 08714729897835), received between Dec 5, 2016 and Sep 30, 2026 — classified as 10 deaths, 964 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (428 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 1,001 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate pain relief. All device components were explanted and discarded by the medical facility. The patient was doing well.

  Patient problems: Pain

  MAUDE report 50944963 ↗
• InjurySep 16, 2026Unexpected Therapeutic Results; Intermittent Energy Output

  It was reported that the spinal cord stimulation (SCS) patient experienced intermittent and inadequate therapy from the implantable pulse generator (IPG) implant. The patient subsequently underwent a procedure wherein the IPG was replaced. The location of the device is unknown. The patient did well postoperatively.

  Patient problems: Pain

  MAUDE report 50791956 ↗
• InjurySep 16, 2026Wireless Communication Problem; Intermittent Energy Output

  It was reported that the spinal cord stimulation (SCS) patient experienced intermittent therapy, difficulties communicating and pain at the implantable pulse generator (IPG) implant site. The patient subsequently underwent a procedure wherein the IPG was replaced. The location of the device is unknown. The patient did well postoperatively.

  Patient problems: Implant Pain; Pain

  MAUDE report 50791823 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) devices were explanted 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 unavailable per physicians response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789773 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent Spinal Cord Stimulator (SCS) explant procedure due to an unknown reason. No further information could be obtained despite good faith efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263453 ↗
• InjuryAug 5, 2026Unexpected Therapeutic Results

  It was reported that the patient's spinal cord stimulation (SCS) was causing nausea, vomiting, more pain than it was before the device was implanted. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) leads were explanted.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 50140790 ↗
• InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  It was reported that the patient experienced shocking sensation and inadequate pain relief from the Spinal Cord Stimulator (SCS) system despite program optimization attempts. The patient subsequently underwent an SCS system explant procedure. No further information could be obtained.

  Patient problems: Pain

  MAUDE report 50081373 ↗
• InjuryJul 28, 2026Nonstandard Device; Unexpected Therapeutic Results

  It was reported that the Spinal Cord Stimulator (SCS) was no longer working and patient experienced loss of stimulation. The patient underwent Spinal Cord Stimulator (SCS) explant procedure.

  Patient problems: Pain

  MAUDE report 50058984 ↗
• InjuryJul 21, 2026Nonstandard Device

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE PATIENT WAS DISCHARGED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892746 ↗
• InjuryJul 20, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS ALLERGIC TO THE SPINAL CORD STIMULATOR (SCS) DEVICE AND WAS NOT RECEIVING ADEQUATE PAIN RELIEF FROM THE THERAPY. AS A RESULT, THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT ABLE TO BE RETURNED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 25884316 ↗
• InjuryJun 10, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN NON TARGET AREA AND THE POCKET SITE WAS HURTING WHILE SITTING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

  Patient problems: Implant Pain; Inappropriate Device Stimulation of Tissue

  MAUDE report 25458160 ↗
• DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE SPINAL CORD STIMULATION (SCS) PATIENT IS DECEASED. THE DEATH IS UNRELATED TO THE DEVICE AND THE DEVICE WAS EXPLANTED. HOWEVER, THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439377 ↗
• DeathMay 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY WHICH WAS FOUND THROUGH A PATIENT OUTREACH CALL. IT WAS REPORTED THAT IT WAS NOT KNOWN IF THE PASSING WAS DEVICE RELATED. THERE WAS NO ALLEGATION OF PATIENT HARM CAUSED BY THE DEVICE OR BY A DEVICE RELATED PROCEDURE. THE PHYSICIAN WAS NOT AWARE OF THE PASSING. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25341223 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326173 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050506 ↗
• InjuryApr 27, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 25000153 ↗
• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN WAS NOTIFIED OF THE PATIENTS PASSING BY THE PATIENTS FAMILY. THE PHYSICIANS OFFICE DOES NOT KNOW THE CAUSE OF DEATH, BUT STATED THE PASSING WAS NOT DEVICE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918825 ↗
• InjuryApr 11, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Inappropriate Device Stimulation of Tissue; Undesired Nerve Stimulation

  MAUDE report 24845889 ↗
• InjuryApr 9, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 24831782 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770226 ↗
• InjuryMar 23, 2026High impedance; Charging Problem; Adverse 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. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO DIFFICULTY CHARGING WHEREIN A NONRECHARGEABLE IPG WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG DEVICE WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662988 ↗
• InjuryMar 17, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THE DEVICE WAS NOT WORKING PROPERLY. ALL COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24614533 ↗
• InjuryMar 16, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24608366 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542732 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521874 ↗

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-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-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-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-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.