NA DB-3128-55BRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00191506023577), received between Jan 12, 2024 and Sep 30, 2026 — classified as 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (23 reports).

4 other recalls cover devices cleared under the same FDA submission (P150031); 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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50941498 ↗
• InjurySep 22, 2026High impedance; Off-Label Use

  Patient problems: Inadequate Pain Relief

  MAUDE report 50862913 ↗
• InjurySep 14, 2026High impedance

  Patient problems: Fall

  MAUDE report 50764461 ↗
• InjurySep 4, 2026High impedance

  It was reported that high impedance was observed on a deep brain stimulation (DBS) extension following a fall. The patient underwent a revision procedure during which the extension was explanted and replaced. The explanted product was not returned for analysis and was disposed of during surgery. The patient was reported to be doing well postoperatively.

  Patient problems: Balance Problems; Fall

  MAUDE report 50619350 ↗
• InjuryMay 19, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD EXTENSION REPLACEMENT DUE TO INADEQUATE STIMULATION CAUSING A DECREASE IN THERAPY AND THE PATIENT'S PREEXISTING SYMPTOMS OF TREMOR TO RETURN ON THE RIGHT AND LEFT SIDE OF THEIR BODY. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS NO VISIBLE DAMAGE OF THE LEAD EXTENSION, HOWEVER DURING THE REVISION PROCEDURE LEAD EXTENSION WAS FRACTURED AS THE PHYSICIAN WAS EXPLANTING THE DEVICE. THE PATIENT IS RECOVERING FROM THE PROCEDURE, HOWEVER, HER THE SYMPTOMS OF TREMOR ARE STILL NOT CONTROLLED, AND WILL BE UNDERGOING ADDITIONAL PROGRAMMING.

  Patient problems: Shaking/Tremors

  MAUDE report 25224976 ↗
• MalfunctionMay 7, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE RIGHT LEAD EXTENSION WAS DISCOVERED TO BE FRACTURED AT THE HEADER BLOCK OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE REASON FOR THE REVISION WAS DUE TO OUT OF RANGE IMPEDANCES THAT WERE DISCOVERED WHEN THE PATIENT WAS SCHEDULED FOR MAGNETIC RESONANCE IMAGING (MRI). THE FRACTURED LEAD EXTENSION WAS REPLACED WITH TWO NEW LEAD EXTENSIONS DURING THE REVISION PROCEDURE AFTER WHICH IMPEDANCES WERE CONFIRMED TO BE WITHIN A NORMAL RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119374 ↗
• InjuryMar 16, 2026High impedance; Nonstandard Device; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INADEQUATE THERAPEUTIC RESPONSE AND RECURRENCE OF PRE-EXISTING TREMORS. FUNCTIONAL TESTING REVEALED HIGH IMPEDANCES. ATTEMPTS TO REPROGRAM AROUND THE HIGH IMPEDANCES WERE ATTEMPTED HOWEVER WERE UNSUCCESSFUL. DURING THE SUBSEQUENT PROCEDURE, THE LEAD EXTENSION WAS FOUND TO BE BENT AND WAS REPLACED WITH ANOTHER LEAD EXTENSION OF THE SAME MODEL. DEVICE ANALYSIS WAS NOT PERFORMED, AS THE COMPONENT WAS DISCARDED BY THE FACILITY. THE PATIENT RECOVERED WELL POSTOPERATIVELY AND IS CURRENTLY ACHIEVING ADEQUATE TREMOR CONTROL.

  Patient problems: Shaking/Tremors

  MAUDE report 24610484 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE DUE TO EROSION AT THE LEAD EXTENSION - LEAD CONNECTION SITE. EROSION WAS SUSPECTED TO HAVE OCCURRED DUE TO PRIOR RADIATION. THE PATIENT HAD A BIOPSY THAT WAS REMOVED IN OFFICE BY ANOTHER PROVIDER, WHO DID TAKE INTO ACCOUNT THE ALREADY FRAGILE SKIN GIVEN PAST RADIATION. THE PATIENT EXPERIENCED SKIN EROSION AND HARDWARE EXPOSURE. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND CULTURES WERE TAKEN; HOWEVER, RESULTS WERE NOT DISCLOSED. POSTOPERATIVELY, THE PATIENT IS STABLE. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 24117325 ↗
• InjuryJan 12, 2026High impedance; Nonstandard Device; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLORATORY REVISION DUE TO HIGH IMPEDANCES ON THE LEADS AND RECURRENCE OF THE PATIENT'S TREMOR. THE PHYSICIAN BEGAN AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND OBSERVED THAT THE CONNECTED EXTENSION LEAD WAS FRAYED. THE POSSIBILITY THAT THE PATIENT MAY HAVE MANIPULATED THE IPG AND HAD RECENTLY EXPERIENCED FALLS COULD BE RELATED TO THE FRAYED EXTENSION; HOWEVER, THIS WAS NOT CONFIRMED, AND IT REMAINS UNKNOWN WHETHER THE PATIENT'S FALLS WERE DEVICE OR STIMULATION RELATED. THE EXTENSION WAS REPLACED AND CONNECTED, IMPEDANCES WERE RESOLVED, AND THE PATIENT'S SYMPTOMS SUBSIDED. THE PATIENT'S POSTOPERATIVE STATUS IS GOOD.

  Patient problems: Fall; Shaking/Tremors

  MAUDE report 24031898 ↗
• MalfunctionDec 30, 2025Fracture; High impedance; Migration; Fracture; High impedance; Migration

  IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED INADEQUATE TREMOR CONTROL. FUNCTIONAL TESTING REVEALED HIGH IMPEDANCES ON MULTIPLE LEFT AND RIGHT CONTACTS. THE PHYSICIAN ATTRIBUTED THE ISSUE TO REPEATED MANIPULATION BY THE PATIENT OF THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH LIKELY TWISTED THE EXTENSION AND CAUSED A FRACTURE NEAR THE HEADER. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE LEAD EXTENSION. ANALYSIS WAS NOT PERFORMED, AS THE EXTENSION SUSTAINED ADDITIONAL DAMAGE DURING EXPLANT AND WAS DISCARDED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ISSUES WERE RESOLVED. ADDITIONAL INFORMATION RECEIVED CONFIRMED ALL FRACTURED LEAD EXTENSION PIECES WERE SUCCESSFULLY REMOVED DURING PROCEDURE AND IPG WAS REPOSITIONED TO ADDRESS MIGRATION AND REMAINS IMPLANTED. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Shaking/Tremors

  MAUDE report 23931261 ↗
• InjuryNov 24, 2025Fracture; High impedance; Appropriate Device Problem Term/Code Not Available; Fracture; High impedance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A FALL AND A LOSS OF THEIR THERAPY. IT WAS NOT KNOWN IF THE FALL WAS RELATED TO THE DBS DEVICE. HIGH IMPEDANCE READINGS WERE DISCOVERED ON THE LEFT-SIDED LEAD. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH IT WAS DISCOVERED THAT THE LEAD EXTENSION WAS PHYSICALLY FRACTURED AT THE IMPLANTABLE PULSE GENERATOR (IPG) PORT SITE. THUS, THE LEAD EXTENSION WAS EXPLANTED AND REPLACED. IMPEDANCE READINGS WERE RESOLVED POSTOPERATIVELY AND THE PATIENT IS RECEIVING THERAPY AGAIN.

  Patient problems: Fall; Insufficient Information

  MAUDE report 23634078 ↗
• InjuryOct 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEHISCENCE OF THE LEFT SIDE LEAD EXTENSION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WHICH WAS PROTRUDING THROUGH THE SKIN AT THE LEAD EXTENSION SITE. THE PATIENT UNDER A PROCEDURE IN WHICH THE AREA WAS OPENED, CLEANED OUT, THE LEAD EXTENSION WAS EXPLANTED AND A NEW DEVICE IMPLANTED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT IS EXPECTED TO FULLY RECOVER AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF BY THE FACILITY.

  Patient problems: Wound Dehiscence

  MAUDE report 23216449 ↗
• InjurySep 5, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) REVISION PROCEDURE TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) FOR ELECTIVE REASONS THERE WERE HIGH IMPEDANCES DISCOVERED ON MULTIPLE CONTACTS. THE PHYSICIAN ASSESSED UPON EXPLORATION THAT ONE OF THE LEAD EXTENSION TAILS HAD BEEN CUT THROUGH. THE PHYSICIAN DECIDED TO REPLACE BOTH EXTENSIONS WHEREIN THE HIGH IMPEDANCE MEASUREMENTS RESOLVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983834 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED LEAD EXTENSION EROSION AT THE CRANIAL IMPLANT SITE, WITH THE EXTENSION PROTRUDING THROUGH THE SKIN. THE PHYSICIAN ATTRIBUTED THE EROSION TO INADEQUATE WOUND CARE AND EXTERNAL PRESSURE FROM WEARING A HAT. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD EXTENSION WAS REPLACED. ANALYSIS WAS NOT PERFORMED AS THE ORIGINAL COMPONENT WAS DESTROYED BY THE FACILITY. THE PATIENT RECOVERED WELL POST-OPERATIVELY.

  Patient problems: Erosion

  MAUDE report 22959738 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AND WOUND DEHISCENCE AT THE SITE OF THE LEAD EXTENSION WHEREIN IT WAS PROTRUDING THROUGH THE SKIN AND THERE WERE SIGNS OF PUSS DRAINING FROM THE AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSION AND IPG WERE EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: Bacterial Infection; Erosion; Purulent Discharge; Wound Dehiscence

  MAUDE report 22545772 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED DRAINAGE AT THE LEAD EXTENSION SITE INCISION. A WOUND WASH WAS PERFORMED IN AN EFFORT TO SALVAGE THE IMPLANTED SYSTEM. HOWEVER, DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE INFECTION HAD SPREAD TO BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET AND BURR HOLE INCISION SITES. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT BELIEVED TO BE DEVICE RELATED. CULTURES WERE PERFORMED, BUT THE RESULTS WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND IS RECOVERING WELL POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 22527216 ↗
• InjuryJun 27, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT DURING AN ELECTIVE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE, THE LEAD EXTENSION APPEARED BENT AND CRACKED UPON REMOVAL FROM THE IPG HEADER. THE PHYSICIAN NOTED THAT THE PATIENT HAS A DIFFICULT TIME SPEAKING AND COULD NOT CONFIRM ANY ADVERSE EVENTS AND THE CAUSE OF THE DAMAGE TO THE LEAD EXTENSION ARE UNKNOWN. THE LEAD EXTENSION WAS REPLACED WITH ANOTHER OF THE SAME MODEL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ANALYSIS OF THE DAMAGED LEAD EXTENSION WAS NOT PERFORMED, AS IT WAS RETAINED BY THE FACILITY. THE PATIENT RECOVERED WELL POST-OPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 22351537 ↗
• InjuryJun 19, 2025High impedance; Structural Problem; High impedance; Structural Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED THE LOSS OF THERAPY AND RETURN OF THEIR PARKINSONS DISEASE SYMPTOMS. FUNCTIONAL TESTING OF THE DEVICE REVEALED HIGH IMPEDANCES ON ALL THE LEFT SIDE OF CONTACTS. THE PATIENT UNDERWENT A PROCEDURE WHERE IT REVEALED THE LEAD EXTENSION HAD A BREAK AT THE INSERTION POINT TO THE IMPLANTABLE PULSE GENERATOR (IPG). THE PHYSICIAN PORT PLUGGED THE DAMAGED LEAD EXTENSION AND SWITCHED THE FUNCTIONING SIDE OF THE LEAD EXTENSION TO THE IPG BEFORE COMPLETING THE PROCEDURE. THE PATIENTS DBS SYSTEM REMAINS IMPLANTED, WAS SUCCESSFULLY REPROGRAMMED. ADDITIONAL INFORMATION WAS NOT PROVIDED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 22290090 ↗
• InjuryJun 18, 2025High impedance; Unexpected Therapeutic Results; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Migration; High impedance; Unexpected Therapeutic Results; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS REPORTED TO BE EXPERIENCING A RECURRENCE OF TREMORS, RIGIDITY, AND SLOWNESS DUE TO IMPEDANCES AND INADEQUATE STIMULATION. THE PHYSICIAN NOTED THAT THE PATIENT'S HISTORY OF FALLS MAY HAVE CONTRIBUTED TO THESE ISSUES. ALTHOUGH REPROGRAMMING WAS ATTEMPTED, THE SYMPTOMS PERSISTED. TO INVESTIGATE THE CAUSE OF THE HIGH IMPEDANCES, THE PATIENT UNDERWENT EXPLORATORY SURGERY. DURING THE PROCEDURE, THE SUTURES SECURING THE IMPLANTABLE PULSE GENERATOR (IPG) BROKE, CAUSING THE IPG TO FLIP AND THE LEAD EXTENSION TO TWIST. AT THIS POINT, THE PHYSICIAN DECIDED TO REVISE THE LEAD EXTENSION, SUCCESSFULLY RESOLVING THE IMPEDANCE ISSUE. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE DOING WELL. THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Fall; Insufficient Information; Movement Disorder; Shaking/Tremors

  MAUDE report 22287183 ↗
• MalfunctionJun 16, 2025High impedance; Failure to Disconnect; High impedance; Failure to Disconnect

  IT WAS REPORTED THAT DURING THE SECOND STAGE OF THE DEEP BRAIN STIMULATION (DBS) PROCEDURE, THE PHYSICIAN ENCOUNTERED A HIGH IMPEDANCE ON THE LEAD EXTENSION AND DIFFICULTIES REMOVING IT FROM LEFT BRAIN LEAD. ATTEMPTS TO REMOVE THE LEAD EXTENSION USING SALINE, OIL AND OTHER SURGICAL TOOLS WAS PERFORMED HOWEVER WERE UNSUCCESSFUL. THE PHYSICIAN ASSESSED THAT THE LEAD EXTENSION SET SCREW WAS DAMAGED WHILE PULLING IT DOWN THE NECKLINE WHICH CLAMPED DOWN ON THE LEAD AS A RESULT WAS UNABLE TO BE DISCONNECTED. THE PHYSICIAN OPTED TO CUT THE LEAD, LEAVING IT ATTACHED TO THE DAMAGED LEAD EXTENSION THEREFORE ABORTED THE LEAD EXTENSION IMPLANT PROCEDURE. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215935 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DEHISCENCE AND PURULENT DISCHARGE AT THE LEAD EXTENSION IMPLANT SITE. CULTURES WERE TAKEN HOWEVER THE RESULTS ARE NOT AVAILABLE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE DBS SYSTEM WAS COMPLETELY REMOVED. THE PHYSICIAN ASSESSED THAT THE PATIENT HAS A HISTORY OF POOR WOUND HEALING THAT MAY HAVE CONTRIBUTED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Impaired Healing; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 22171969 ↗
• InjuryApr 10, 2025High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SEVERAL ACCIDENTAL NON-DEVICE RELATED FALLS AND NOTED A HIGH IMPEDANCE ON BOTH LEADS LEVELS THREE AND FOUR VIA FUNCTIONAL TESTING. THE PATIENT UNDERWENT A PROCEDURE WHEREIN TESTING CONFIRMED THE LEAD EXTENSION WAS THE DEVICE WITH HIGH IMPEDANCES AS A RESULT WAS REPLACED WITH ANOTHER OF THE SAME MODEL. IT WAS NOTED THAT THE RIGHT BRAIN LEAD HAD A CRIMP AT THE TAIL END WHERE IT CONNECTS WITH THE EXTENSION, HOWEVER IT IS UNKNOWN WHICH SERIAL NUMBER LEAD HAD THE CRIMP THEREFORE ARE REPORTING ON BOTH LEADS. ADDITIONAL TESTING REVEALED A HIGH IMPEDANCE IN CONTACT L1, ATTEMPTS TO CLEAR THE HIGH IMPEDANCE WAS PERFORMED HOWEVER WERE UNSUCCESSFUL AS A RESULT THE PHYSICIAN OPTED TO COMPLETE THE PROCEDURE. THE LEADS AND LEAD EXTENSION REMAIN IMPLANTED, AND THE SYSTEM WAS SUCCESSFULLY PROGRAMMED AROUND THE HIGH IMPEDANCE CONTACT. THE PATIENT DID WELL POST-OPERATIVELY AND IS RECEIVING ADEQUATE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21821431 ↗
• InjuryApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION WITH A POTENTIAL INFECTION AT THE DBS IMPLANT SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE DBS LEAD EXTENSION WAS REMOVED. THE PHYSICIANS ASSESSMENT WAS THOUGHT TO BELIEVE THE LEAD EXTENSION HAS A SHARP EDGE AT THE CONNECTION SITE CAUSING THE EROSION, HOWEVER IT IS UNKNOWN WHICH TAIL END IS BEING REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION PROVIDED CONFIRMED THE DBS DEVICES REMAIN IMPLANTED AND CONTINUE TO DELIVER THERAPY. THE PATIENT HAD UNDERGONE A PROCEDURE WHEREIN A WOUND WASHOUT WAS COMPLETED BEFORE RECLOSING THE INCISION. IT WAS CONFIRMED THERE WAS NO INFECTION PRESENT HOWEVER THE PATIENT WAS PRESCRIBED ANTI-BIOTICS PER THE PHYSICIANS ASSESSMENT. THE PATIENT IS DOING FINE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21801918 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED TIGHTNESS AT THE LEAD EXTENSION AND IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PHYSICIAN CLEANED OUT SCAR TISSUE AROUND THE LEAD EXTENSION AS A RESULT RELEASED TENSION FROM THE LEAD AND COMPLETED THE PROCEDURE. IT WAS NOTED THAT SCARRING FORMED AT THE LEAD EXTENSION CAUSING THE TIGHTNESS PER THE PHYSICIANS ASSESSMENT. THE DBS DEVICES REMAIN IMPLANTED AND CONTINUE TO DELIVER THERAPY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Capsular Contracture

  MAUDE report 21769961 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION IN THE SKIN OVERLAYING THE EXTENSION HEADER SITE UNDER THE SCALP WHEREIN THERE IS THE PRESENCE OF A SMALL HOLE.

  Patient problems: Erosion

  MAUDE report 21767484 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• Z-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• Z-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the