DBSRecalls & reported problems across all models

We found 18 models of DBS by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 612 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2016 and Sep 28, 2026 — classified as 2 deaths, 172 injuries, 438 malfunctions.

The most frequently reported specific device problem is “Break” (120 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DBS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 27, 2022Completed

   There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

   Z-0217-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported DBS problems

DBS models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DBS™ 3389S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  1 death183 reports
• DBS™ 3387S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  155 reports
• DBS™ 3389S-40

  implanted subcortical electrical Stimulator (motor disorders)
  99 reports
• DBS™ 3387S-40

  Stimulator, electrical, implanted, for parkinsonian symptoms
  1 recall30 reports
• DBS 3389S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  45 reports
• DBS 3387S-40

  implanted subcortical electrical Stimulator (motor disorders)
  1 death24 reports
• DBS™ 3708660

  implanted subcortical electrical Stimulator (motor disorders)
  23 reports
• DBS ™ 3389S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  22 reports
• DBS ™ 3387S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  8 reports
• DBS ™ 3387S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  8 reports
• DBS™ 3389S-40

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  5 reports
• DBS™ 3708695

  implanted subcortical electrical Stimulator (motor disorders)
  3 reports
• DBS™ 3391S-40

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  2 reports
• DBS™ 3708640

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  1 report
• DBS™ 3755

  INSTRUMENT, SURGICAL, NON-POWERED
  1 report
• DBS™ 3389S-28

  implanted subcortical electrical Stimulator (motor disorders)
  1 report
• DBS ™ 3391S-40

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  1 report
• DBS 3389S-28

  implanted subcortical electrical Stimulator (motor disorders)
  1 report

Recent DBS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916621 ↗
• MalfunctionJun 5, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR NORMAL END OF SERVICE BATTERY REPLACEMENT TODAY. IN PRE-OP, ALL IMPEDANCES WERE NORMAL, HOWEVER, DURING THE PROCEDURE THERE WAS A SHORT (200 OHMS) DISCOVERED BETWEEN CONTACTS 8 AND 9 ON THE RIGHT HEMISPHERE. CALLER STATED THE PATIENT WAS PROGRAMMED WITH A DOUBLE MONOPOLE (C+ 8- 9-) ON THOSE CONTACTS. DURING THE PROCEDURE, THE EXTENSION TAILS WERE SWITCHED IN THE PORTS OF THE BATTERY AND IT WAS DETERMINED THAT THE ISSUE WAS RELATED TO THE LEAD OR EXTENSION AS OPPOSED TO THE BATTERY. THE PATIENT WASN'T CONSENTED FOR ANYTHING OTHER THAN THE BATTERY REPLACEMENT SO ONLY THE BATTERY WAS REPLACED TODAY. IN POST-OP, THE IMPEDANCE MEASUREMENT BETWEEN 8-9 HAD DECREASED TO 44 OHMS. CALLER STATED PROGRAMMING WAS LEFT AS IS ON C+ 8- 9- AND PATIENT APPEARED TO BE GETTING SYMPTOM CONTROL FOR TREMOR WITH IT NOTED THAT PATIENT WAS STILL COMING OFF SEDATION AT THE TIME. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER STATED (B)(6) UNIVERSITY WILL BE RETURNING THE EXPLANTED BATTERY. CALLER STATED THEY PLAN TO CHECK-IN WITH THE PATIENT IN A WEEK TO SEE HOW THEIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410069 ↗
• MalfunctionJun 5, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR NORMAL END OF SERVICE BATTERY REPLACEMENT TODAY. IN PRE-OP, ALL IMPEDANCES WERE NORMAL, HOWEVER, DURING THE PROCEDURE THERE WAS A SHORT (200 OHMS) DISCOVERED BETWEEN CONTACTS 8 AND 9 ON THE RIGHT HEMISPHERE. CALLER STATED THE PATIENT WAS PROGRAMMED WITH A DOUBLE MONOPOLE (C+ 8- 9-) ON THOSE CONTACTS. DURING THE PROCEDURE, THE EXTENSION TAILS WERE SWITCHED IN THE PORTS OF THE BATTERY AND IT WAS DETERMINED THAT THE ISSUE WAS RELATED TO THE LEAD OR EXTENSION AS OPPOSED TO THE BATTERY. THE PATIENT WASN'T CONSENTED FOR ANYTHING OTHER THAN THE BATTERY REPLACEMENT SO ONLY THE BATTERY WAS REPLACED TODAY . IN POST-OP ,THE IMPEDANCE MEASUREMENT BETWEEN 8-9 HAD DECREASED TO 44 OHMS. CALLER STATED PROGRAMMING WAS LEFT AS IS ON C+ 8- 9- AND PATIENT APPEARED TO BE GETTING SYMPTOM CONTROL FOR TREMOR WITH IT NOTED THAT PATIENT WAS STILL COMING OFF SEDATION AT THE TIME. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER STATED RUSH UNIVERSITY WILL BE RETURNING THE EXPLANTED BATTERY. CALLER STATED THEY PLAN TO CHECK-IN WITH THE PATIENT IN A WEEK TO SEE HOW THEIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409969 ↗
• MalfunctionMay 1, 2026Material Deformation

  IT WAS REPORTED THAT LEAD BENDING WAS OBSERVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055751 ↗
• MalfunctionApr 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEAD WAS IDENTIFIED PRIOR TO USE AS HAVING AN ELECTRODE THAT WAS 1 MM SHORTER THAN THE STANDARD LENGTH. THE DEVICE WAS NEVER IMPLANTED. VISUAL INSPECTION AND MEASUREMENT CONFIRMED THE 1 MM SHORTER ELECTRODE. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT-RELATED CONTRIBUTING FACTORS WERE REPORTED. THE PRODUCT WAS COLLECTED AND RETURNED, AND THE ISSUE WAS REPORTED AS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048701 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POSTOPERATIVE BLEEDING AND PURULENT DISCHARGE WERE OBSERVED AT THE CRANIAL LEAD SITE. IT WAS RECOMMENDED TO COMMUNICATE WITH THE PHYSICIAN. THE ISSUE WAS SAID TO BE RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Purulent Discharge

  MAUDE report 24886604 ↗
• MalfunctionApr 14, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, ABNORMALLY HIGH LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS NEVER IMPL ANTED. THE LEAD WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24878392 ↗
• MalfunctionApr 13, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD LOCK COULD NOT BE ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858653 ↗
• MalfunctionApr 7, 2026Break; Material Deformation

  IT WAS REPORTED THAT, PRIOR TO IMPLANTATION DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD WAS NOTED TO BE BENT. THE LEAD WAS R EPLACED ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807136 ↗
• MalfunctionApr 6, 2026High impedance; Impedance Problem

  ADDITIONAL INFORMATION CLARIFIED THAT THE IMPEDANCES WERE HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794336 ↗
• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT THE LEAD GUIDEWIRE COULD NOT BE PULLED OUT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792504 ↗
• MalfunctionApr 6, 2026Low impedance

  IT WAS REPORTED THAT THE LEAD WAS IDENTIFIED AS HAVING AN ELECTRODE FAILURE DURING A DEEP BRAIN STIMULATION PROCEDURE WHEN IMPEDANCE TESTING DID NOT PASS AND INDICATED A SHORT CIRCUIT. THE LEAD WAS REPLACED ON THE SAME DAY TO COMPLETE THE SURGERY. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791759 ↗
• MalfunctionMar 30, 2026Break; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). MANUFACTURING REPRESENTATIVE REPORTED THAT THE LEAD WAS BENT UPON OPENING THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734714 ↗
• MalfunctionMar 30, 2026Break; High impedance

  IT WAS REPORTED THAT INTRAOPERATIVELY A LEAD FRACTURE WAS IDENTIFIED, RESULTING IN EXCESSIVELY HIGH ELECTRIC RESISTANCE AND AN OPEN CIRCUIT. MANUFACTURING REPRESENTATIVE REPORTED THAT THERE WAS DAMAGE TO THE SCREW OF THE EXTENSION AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724047 ↗
• MalfunctionMar 26, 2026Insufficient Device Problem Information

  THE HEALTHCARE PROVIDER PROVIDED ADDITIONAL INFORMATION CLARIFYING THAT THE LEADS ARE NOT BROKEN AND ADDED THAT THEY SEE THE PATIENT REGULARLY AND DBS ANALYST EVERY 3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699774 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls