Precision ™ SC-5312Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729764465), received between Jun 1, 2017 and Jan 25, 2024 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (9 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN WHILE CHARGING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18578037 ↗
• InjuryAug 22, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CHARGER BURNED PATIENTS SKIN DURING CHARGING AND WAS CONFIRMED TO BE A SECOND DEGREE BURN. THE PATIENT WAS ON MEDICATION WHICH CAUSED HIM NOT TO FEEL SO MUCH HEAT COMING FROM THE CHARGER.

  Patient problems: Burn(s)

  MAUDE report 15266920 ↗
• InjuryAug 10, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERHEATING OF DEVICE. THE PATIENTS DEVICE KEEPS IT ON TOO LONG AND HAS GOTTEN SMALL AND WATER OR HEAT BLISTERS.

  Patient problems: Burn(s)

  MAUDE report 12300618 ↗
• InjuryJul 30, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENTS POCKET SITE WAS BURNED DUE TO CHARGER GETS HOT WHEN CHARGING THE IPG AND WAS HAVING DISCOMFORT. SYMPTOMS OF BLISTER AND DRAINING WERE NOTED. IT WAS UNKNOWN IF THE PATIENT WAS PROVIDED WITH MEDICATION. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAS NO INFECTION AND WOUND WAS HEALING. THE PATIENT WAS DOING WELL.

  Patient problems: Discomfort; Superficial (First Degree) Burn

  MAUDE report 10346096 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BURN MARKS WHILE CHARGING THE IPG.

  Patient problems: Burn(s)

  MAUDE report 10236841 ↗
• InjuryFeb 26, 2020Overheating of Device; Overheating of Device

  A REPORT WAS RECEIVED THAT THE PATIENT HAD BLISTER AT BACK NEAR THE IPG SITE WHICH WAS DESCRIBED AS TENDER. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS.

  Patient problems: Burning Sensation; Partial thickness (Second Degree) Burn; Rash

  MAUDE report 9756572 ↗
• MalfunctionJan 8, 2020Defective Device

  DEFECTIVE BOSTON SCI BATTERY DISABLED MY CRADLE CHARGER. THAT CHARGER DISABLED MY REPLACEMENT BATTERY. THAT BATTERY DISABLED THE REPLACEMENT CRADLE. MY REP PUT IT IN HIS CHARGING CRADLE, WHICH BECAME DISABLED. IN TURN, IT THEN DISABLED HIS BATTERY. IT HAS THE BEHAVIOR OF A VIRUS, AND I A, CONCERNED ABOUT MY IPG UNIT. BOSTON HAS REQUESTED THE RETURN OF THEIR LOANER EQUIPMENT, AND ALSO WANTS ME TO RETURN MY ORIGINAL EQUIPMENT TO THEM IMMEDIATELY (AND WANTS ME TO PURCHASE A NEW CHARGING UNIT AND BATTERY). UNABLE TO CHARGE SPINAL STIM. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9570629 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD A MARK ON THE SKIN THAT SEEMED LIKE A BURN. THE PATIENT WAS PRESCRIBED WITH AN OINTMENT AND WAS DOING WELL.

  Patient problems: Burn(s); No Code Available

  MAUDE report 9488649 ↗
• InjuryDec 11, 2019Overheating of Device; Overheating of Device

  A REPORT WAS RECEIVED THAT THE PATIENT WAS BURNED TWICE BY THE EXTERNAL CHARGER. BLISTERS AROUND THE AFFECTED AREA WAS NOTED. THE PHYSICIAN CONFIRMED THAT NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING WELL.

  Patient problems: Burn(s)

  MAUDE report 9450452 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED A SMALL BLISTER AND EXPERIENCED A BURNING SENSATION WHILE CHARGING. NO INTERVENTION WAS PROVIDED TO ADDRESS THE BLISTER, THE PATIENT WAS PROVIDED WITH PROPER CHARGING TECHNIQUES, AND WILL BE FOLLOWED BY THE FIELD CLINICAL ENGINEER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED TWO BLISTERS. THE PATIENT WAS CHARGING IN ONE HOUR SESSIONS AT WHICH TIME SHE DEVELOPED A LARGE BLISTER, WHICH THEN SUBSIDED. THE PATIENT THEN CHANGED TO 45 MINUTE CHARGING SESSIONS WHICH IS WHEN THE SMALL BLISTER DEVELOPED.

  Patient problems: Burn(s)

  MAUDE report 9434507 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE CHARGER WAS BURNING THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 9012503 ↗
• InjurySep 12, 2019Overheating of Device; Overheating of Device

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED OVERHEATING OF THE CHARGER WHICH RESULTED TO BURN THE SKIN OVER THE IPG SITE. IT WAS NOTED THAT THE BURN LEFT BLISTERS ON THE SKIN. IT WAS UNKNOWN IF THERE WAS MEDICAL INTERVENTION PROVIDED AND THE BURN WAS YET HEALED. NO FURTHER COURSE OF ACTION NEEDED.

  Patient problems: Burn(s)

  MAUDE report 9007236 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING BLISTERING AT THE IPG SITE WHERE THE CHARGER WAS PLACED WITH THE ADHESIVE PATCHES. THE PHYSICIAN BELIEVED THAT THE BLISTERING WAS NOT DEVICE RELATED BUT DUE TO PATIENTS DECREASED IMMUNE SYSTEM. THE PATIENTS BLISTER WAS CLEANED AND DRESSED.

  Patient problems: Complaint, Ill-Defined; Partial thickness (Second Degree) Burn

  MAUDE report 8983564 ↗
• InjuryAug 2, 2019Overheating of Device; Overheating of Device

  A REPORT WAS RECEIVED THAT THE PATIENT WAS GETTING BLISTERS FROM THE CHARGER HEAT AND IT WAS LEAKING OUT.

  Patient problems: Burn(s); Fluid Discharge; No Code Available; Skin Irritation

  MAUDE report 8858162 ↗
• InjuryMay 8, 2019Charging Problem; Charging Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS CHARGING THE IPG FREQUENTLY. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8593482 ↗
• InjuryMar 27, 2019Failure to Charge; Failure to Charge

  A REPORT WAS RECEIVED THAT THE PATIENTS IPG WAS DEPLETED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8456621 ↗
• InjuryJan 21, 2019Charging Problem; Positioning Problem; Charging Problem; Positioning Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HER IPG. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8264093 ↗
• InjuryNov 12, 2018Charging Problem; Charging Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. DATABASE ANALYSIS REVEALED THE CHARGE PROFILE SHOWS SIGNS OF POOR CHARGER TO IPG COUPLING AND THE CHARGER THERMISTOR TRIGGERING OFTEN WHICH CAN DELAY CHARGING TIMES. THE PATIENT UNDERWENT AN IPG REVISION PROCEDURE WHEREIN THE POCKET SIZE WAS REDUCED. NO DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8061904 ↗
• InjuryOct 22, 2018No Display/Image; Overheating of Device; Charging Problem; No Display/Image; Overheating of Device; Charging Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO PAIN EXACERBATION. IT WAS REPORTED THAT THE CHARGER WAS BEEPING EVEN WHEN PROPERLY LINED UP OVER THE IPG. THE LED SCREEN OFF THE CHARGER REMAINED ORANGE. THE CHARGER ALSO BECAME WARM THEREBY MAKING CHARGING THE INTERNAL IPG DIFFICULT, AND CAUSING IT TO DEPLETE. THE PATIENT HAD AN OUT-PATIENT STAY, AND WAS PROVIDED WITH A REPLACEMENT CHARGER. THE PATIENT HAS REGAINED PAIN THERAPY WITH THE REPLACEMENT CHARGER. PER THE INFORMATION PROVIDED NO MEDICAL INTERVENTION WAS PROVIDED DURING THE OUT-PATIENT STAY.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 7991699 ↗
• InjuryAug 15, 2018Overheating of Device; Overheating of Device

  A REPORT WAS RECEIVED THAT THE PATIENT IPG POCKET SITE FELT HOT WHILE CHARGING. PHYSICIAN ASSESSED THAT THE PATIENT HAD A LOW TEMPERATURE BURN THAT RESULTED IN A BLISTER. A GAUZE DRESSING WAS APPLIED AND PATIENT WAS ADVISED TO DISCONTINUE USE OF THE DEVICE FOR ONE WEEK.

  Patient problems: Burn(s)

  MAUDE report 7787210 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS BURNED WHILE CHARGING THE IPG. THE PATIENT WAS GIVEN SOME KIND OF A PATCH AND A PROPHYLAXIS FOR INFECTION. THE PATIENT WAS DOING WELL AND NOTED THAT THE BURN WAS NO LONGER THERE.

  Patient problems: Burn(s)

  MAUDE report 7174111 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT SUSTAINED A BURN FROM THE CHARGER WHILE CHARGING THE IMPLANT.

  Patient problems: Burn(s)

  MAUDE report 7039539 ↗
• InjuryOct 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT'S FINGER WAS BLISTERED BY THE CHARGER AFTER CHARGING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 6908474 ↗
• InjurySep 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED EXCESSIVE SWEATING THROUGHOUT HER BODY, DISCOMFORT, AND THE SENSATION OF BURNING DUE TO THE IPG FEELING HOT WHILE CHARGING.

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

  MAUDE report 6892160 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED A SMALL BLISTER NEAR THE BOTTOM PART OF THE IPG SITE WHILE USING THE ADHESIVE PATCH DURING CHARGING SESSION. IT WAS NOTED THAT THE BLISTER MAY HAVE CAUSED BY ADHESIVE PATCH OR CHARGING PROCESS. CORTIZONE WAS PRESCRIBED TO TREAT THE BLISTER. PROPER CHARGING TECHNIQUES WERE ADVISED AND THE PATIENT WAS DOING WELL.

  Patient problems: Burn(s)

  MAUDE report 6768396 ↗

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-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-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-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-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
• 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.