Precision™ SC-6412-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729821243), received between Jan 4, 2019 and Jul 10, 2026 — classified as 39 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Overheating of Device; Charging Problem

  It was reported that the patient was experiencing difficulty charging the Implantable Pulse Generator (IPG). The charger would get extremely hot when charging and patient noted actual burns on the back, burning sensation from the inside out, and redness over the battery site and entire spine area. The patient was provided with a new charger, had a program optimization done and is currently doing well.

  Patient problems: Burn(s); Burning Sensation; Erythema

  MAUDE report 25786434 ↗
• InjuryJul 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BLISTER OVER THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AFTER EXPERIENCING HEAT, PAIN AND DISCOMFORT DURING AN IPG CHARGING SESSION. THE PATIENT USED NEOSPORIN AND IPG SITE WAS BANDAGED.

  Patient problems: Burn(s); Discomfort; Pain; Partial thickness (Second Degree) Burn

  MAUDE report 25717658 ↗
• InjuryMay 11, 2026Charging Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURN AND BUBBLED SKIN AFTER USING THE SPINAL CORD STIMULATOR (SCS) CHARGING SYSTEM WHILE SLEEPING. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140066 ↗
• InjuryApr 13, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT SUSTAINED BURNS AND BLISTERS DUE TO THE CHARGER BURNING THROUGH THE BELT. IT WAS NOTED THAT THE BLISTERS HAVE SINCE BEEN RESOLVED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 24853842 ↗
• InjuryMar 23, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A SECOND-DEGREE BURN FROM THE SPINAL CORD STIMULATOR (SCS) CHARGER. THE PATIENT INFORMED THAT THEY TUCKED THE CHARGER INTO THEIR PANTS AND IT GOT REALLY HOT DURING CHARGING. THE PATIENT THEN NOTED SENSITIVITY AND REDNESS AT THE IMPLANT SITE AND WENT TO THE EMERGENCY ROOM. STEROID CREAM WAS APPLIED WHICH HELPED A BIT AND THE PATIENT WAS ALSO ADVISED TO USE BACITRACIN OINTMENT FOR HEALING. THE PATIENT WAS EDUCATED ON BEST PRACTICES FOR CHARGING.

  Patient problems: Burning Sensation; Erythema; Hypersensitivity/Allergic reaction; Partial thickness (Second Degree) Burn

  MAUDE report 24659268 ↗
• InjuryJan 26, 2026Overheating of Device

  IT WAS REPORTED THAT PATIENT HAD A RED MARK ON SKIN DUE TO OVERHEATED CHARGER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMINISTERED WITH MEDICATION AND WAS FULLY RECOVERED.

  Patient problems: Burn(s)

  MAUDE report 24185258 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTICED A BLISTER AND A BLOOD FROM THE POCKET SITE WHILE CHARGING. THE PATIENT APPLIED A TRIPLE ANTIBIOTIC CREAM ON THE BLISTER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD NO MORE BLISTERS.

  Patient problems: Hypersensitivity/Allergic reaction; Partial thickness (Second Degree) Burn

  MAUDE report 23829406 ↗
• MalfunctionJul 30, 2025Fire; Overheating of Device; Fire; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S CHARGER FOR THE IMPLANTABLE PULSE GENERATOR (IPG) OVERHEATED AND BURNED. IT WAS NOTED THAT THE CHARGER WAS SITTING IN THE CHARGING BASE STATION AND STARTED TO MELT AND LIT ON FIRE. THE PATIENT HAD TO TAKE THE CHARGER OUTSIDE SO IT WOULD NOT START A FIRE IN HIS HOME. THE PATIENT WAS DOING FINE, AND THE CHARGER WAS NOT RETURNED AS IT WAS DISPOSED OF BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668589 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN. THE PHYSICIAN PROVIDED WOUND CARE TO PATIENT.

  Patient problems: Burn(s)

  MAUDE report 22029144 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A BURN FROM THE CHARGING PUCK. A SMALL RED MARK AND A SCAB WAS NOTED AT THE BURN SITE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 21559150 ↗
• InjuryOct 25, 2024Overheating of Device; Charging Problem; Overheating of Device; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IMPLANT AND STATED THAT THE CHARGER BURNED THE PATIENTS BACK.

  Patient problems: Burn(s)

  MAUDE report 20535622 ↗
• InjuryAug 8, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CHARGING PUCK GETS SO HOT WITHIN MINUTES, AND IT BURNS PATIENTS SKIN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 19940201 ↗
• InjuryJul 1, 2024Defective Alarm; Failure to Charge; Overheating of Device; Defective Alarm; Failure to Charge; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS CHARGER WAS TOO HOT THAT IT BURNED HER.

  Patient problems: Burn(s)

  MAUDE report 19642343 ↗
• InjuryMar 29, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT WHEN PATIENT CHARGE THE IPG THE CHARGING DISK GOT REALLY HOT AND BURNED THE SKIN. THE PATIENT WAS GIVEN SILVADENE CREAM TO APPLY AT THE SKIN.

  Patient problems: Burn(s)

  MAUDE report 19008690 ↗
• InjuryNov 30, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS CHARGING PUCK OVERHEATED AND LEFT A BURN BLISTER ON THE SKIN. IT WAS NOTED THAT THE PATIENT FELL ASLEEP WITH THE CHARGER ON AND WAS NOT ABLE TO REMOVE IT UNTIL MORNING. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 18243609 ↗
• InjuryNov 10, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS CHARGER WAS HOT TO THE TOUCH AND BURNED THE PATIENT WHILE CHARGING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18110908 ↗
• InjuryNov 10, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS CHARGER WAS HOT TO THE TOUCH AND BURNED THE PATIENT WHILE CHARGING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD LOSS WEIGHT WHICH COULD BE CONTRIBUTING TO THE CHARGING ISSUES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18110874 ↗
• InjuryAug 15, 2023Defective Alarm; Overheating of Device; Delayed Charge Time; Defective Alarm; Overheating of Device; Delayed Charge Time

  IT WAS REPORTED THAT THE CHARGER OVERHEATED AND BURNED THE PATIENTS SKIN AROUND THE CONTACT AREA IN THE BACK. THE CHARGER WAS TAKING LONGER TO CHARGE AND WAS NOT REACHING THE DOUBLE BEEP. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS CURRENTLY HEALED FROM THE BURN.

  Patient problems: Burn(s)

  MAUDE report 17553470 ↗
• InjuryMay 30, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT DURING CHARGING AS THE CHARGER WILL GET HOT WHICH CAUSED SKIN REDNESS, PAIN AND IRRITATION. THE PATIENT WAS GIVEN A CREAM BY THE PHYSICIAN, AND IT SEEMED TO HAVE RESOLVED THE ISSUE.

  Patient problems: Discomfort; Pain; Skin Inflammation/ Irritation

  MAUDE report 17018351 ↗
• InjuryFeb 28, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURN AT THE IPG SITE WHILE CHARGING. THE BURNED AREA WAS PAINFUL TO TOUCH AND HAD A HUGE AMOUNT OF SWELLING. THE PATIENT STATED THAT THE CHARGER MAY HAVE OVER HEATED. THE PATIENT APPLIED ICE AND BURN CREAM ON THE AREA AS WELL AS TOOK AN IBUPROFEN.

  Patient problems: Burn(s); Pain; Swelling/ Edema

  MAUDE report 16451137 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BURNED HERSELF WHEN SHE STARTED CHARGING CAUSING BLEEDING AT THE IMPLANT SITE.

  Patient problems: Burn(s)

  MAUDE report 15856174 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE CHARGER TAPED TO HIS BACK THEN WENT TO GET AN X-RAY AND THERE LOOKS LIKE A BURN AT THE IMPLANT SITE.

  Patient problems: Burn(s)

  MAUDE report 15619659 ↗
• InjuryAug 18, 2022Overheating of Device; Charging Problem; Overheating of Device; Charging Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A BURN FROM THE CHARGER. IT WAS NOTED THAT THE PATIENT CHARGED FOR TWO HOURS AND AT THE END OF THE CHARGING SESSION, THE CHARGING PUCK WAS VERY HOT TO TOUCH AND HAD RIPPED OFF THE PATIENTS SKIN WHEN IT WAS REMOVED.

  Patient problems: Burn(s); Discomfort; Skin Inflammation/ Irritation

  MAUDE report 15250777 ↗
• MalfunctionJul 27, 2022Fire; Fire

  IT WAS REPORTED THAT THE PATIENTS CHARGER WAS ON THE BASE STATION AND EXPLODED. THE CHARGER FLEW AND HIT THE COUNTER AND CAUSED FIRE. THE DEVICE WAS NOT RETURNED TO BSN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117573 ↗
• InjuryJun 28, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERHEATING OF CHARGING DISK WHEN PERFORMING CHARGING SESSIONS. PATIENT REPORTS WHEN CHARGING DISK WAS REMOVED, BURNED MARKS WERE VISIBLE.

  Patient problems: Burn(s)

  MAUDE report 14840964 ↗

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-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-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-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-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.