NA NM-3138-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 08714729820765), received between Feb 6, 2018 and Sep 22, 2026 — classified as 188 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High impedance” (55 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 198 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Shaking/Tremors; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 50862801 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced erosion of the skin at the lead extension and leads site of the Deep Brain Stimulation (DBS) system due to the consistent Continuous Positive Airway Pressure (CPAP) usage and the strap going directly over the lead extension connection site. The patient underwent an explant procedure in which the lead extensions and the IPG were explanted to allow for healing and re-implant at a later time. The physician stated that the patient did not experience any additional symptoms due to the erosion, no additional findings were identified during the procedure, and the patient was tested for infection and the results were negative. The patient is stable post-operatively, and the devices will not be returned for analysis as they were disposed of by the facility.

  Patient problems: Erosion

  MAUDE report 50245639 ↗
• InjuryJul 29, 2026High impedance; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  It was reported that a patient implanted with a Deep Brain Stimulation (DBS) system for the treatment of Obsessive Compulsive Disorder (OCD) underwent a lead extension revision procedure due to high impedances. The reported high impedances resulted in a loss of therapy effectiveness in the right hemisphere, with recurrence of the patient's OCD symptoms, including checking compulsions and pathological doubt, accompanied by comorbid depressive and anxiety symptoms. As a result, the patient underwent an unscheduled revision procedure and required hospitalization beyond the standard of care. Following the procedure, DBS therapy was reactivated, and the patient was discharged on the same day. The most recently available information indicated that the patient continues to experience symptoms of the underlying condition. However, this is not unexpected, as symptomatic improvement is generally observed within 4 to 8 weeks. From a physical standpoint, the patient is recovering well from surgery.

  Patient problems: Anxiety; Depression; Insufficient Information

  MAUDE report 50073429 ↗
• InjuryJun 18, 2026High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING HIGH IMPEDANCES RESULTING IN THE INABILITY TO RECEIVE MAGNETIC RESONANCE (MRI) IMAGING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE DBS SYSTEM WAS INTERROGATED TO DETERMINE WHERE THE HIGH IMPEDANCES WERE COMING FROM. IT WAS DETERMINED THAT THE HIGH IMPEDANCES WERE COMING FROM THE RIGHT LEAD EXTENSION. THE RIGHT LEAD WAS DISCONNECTED FROM THE LEAD EXTENSION WITH IMPEDANCES AND CONNECTED TO THE SECOND LEAD EXTENSION THAT WAS PREVIOUSLY STAGED DURING THE INITIAL PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE HIGH IMPEDANCE ISSUE WAS RESOLVED. THE PHYSICIAN DECIDED TO LEAVE THE EXTENSION WITH HIGH IMPEDANCE IMPLANTED AND CONNECTED IT TO THE IPG BUT REMAINS DEACTIVATED AND NOT IN SERVICE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549182 ↗
• MalfunctionMay 27, 2026Fracture; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LOSS OF STIMULATION RESULTING IN A RETURN IN DYSTONIA SYMPTOMS AND DETERIORATION IN TONE CONTROL AND UPPER LIMB FUNCTION. X-RAY IMAGING WAS PERFORMED AND CONFIRMED THAT THE LEAD EXTENSIONS WERE FRACTURED. THE PATIENT WAS SCHEDULED FOR A FUTURE REVISION TO REPLACE BOTH LEAD EXTENSIONS. THE REVISION HAS NOT YET OCCURRED.

  Patient problems: Ambulation or Postural Difficulties; Inappropriate Device Stimulation of Tissue; Movement Disorder

  MAUDE report 25303136 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD EXTENSION REVISION DUE TO INFECTION. THE PATIENT EXHIBITED HARDWARE EXPOSURE AND AN OPEN WOUND. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND CULTURES WERE TAKEN, BUT THE RESULTS WERE NOT DISCLOSED. THE DEVICE HAS BEEN REACTIVATED AT THE PREVIOUS SETTINGS, AND THE PATIENT IS RECEIVING ADEQUATE STIMULATION. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Bacterial Infection; Erosion; Wound Dehiscence

  MAUDE report 25236669 ↗
• InjuryMay 4, 2026High impedance; Nonstandard Device; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT HAD FALLEN OUT OF BED AND STRUCK THEIR HEAD ON THE NIGHTSTAND, RELATED TO RAPID EYE MOVEMENT (REM) SLEEP BEHAVIOR DISORDER SECONDARY TO PARKINSON'S DISEASE. THE FALL WAS DETERMINED NOT TO BE RELATED TO THE DBS SYSTEM. EXTENSION WAS PRESUMABLY DAMAGED WHEN THE PATIENT FELL OUT OF BED. FOLLOWING THE FALL, THE PATIENT REPORTED WORSENING PARKINSON'S SYMPTOMS, PARTICULARLY REDUCED TREMOR CONTROL ON THE RIGHT SIDE. XRAYS REVEALED MISALIGNMENT OF THE LEAD IN THE EXTENSION HEADER. DURING REVISION, REINSERTION ATTEMPTS OF THE LEFT LEAD DID NOT RESOLVE THE IMPEDANCES. TROUBLESHOOTING IDENTIFIED THE EXTENSION AS THE SOURCE OF THE IMPEDANCE ISSUE. THE PHYSICIAN REPLACED THE LEFT EXTENSION, AND UPON CONNECTING THE NEW EXTENSION, ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. THE EXPLANTED LEAD EXTENSION WAS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. THE PATIENT IS DOING WELL POSTOPERATIVELY WITH STIMULATION TURNED ON AT THEIR PRIOR SETTINGS.

  Patient problems: Fall; Shaking/Tremors

  MAUDE report 25075074 ↗
• InjuryApr 29, 2026High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO HIGH IMPEDANCES IN THE LEAD EXTENSION. ELECTROCAUTERY WAS REPORTEDLY USED DURING THE PROCEDURE. POSTOPERATIVELY, THE PATIENT IS DOING WELL. THE LOCATION OF THE EXPLANTED DEVICE REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024777 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THIS ELECTRICAL STIMULATOR WAS PLANNED TO BE IMPLANTED; HOWEVER, THE CARTON AND STERILE BLISTER PACKAGING WERE NOTED TO HAVE BEEN DAMAGED. THIS PRODUCT WAS NOT USED. AS OF TODAY, THIS PRODUCT HAS NOT BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017861 ↗
• MalfunctionMar 18, 2026Fracture; High impedance; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON BOTH LEADS. IT WAS NOTED THAT THIS WAS A CHILD DYSTONIA PATIENT AND THE LEAD EXTENSIONS WERE SECURED USING A CRANIAL PLATE OVER THE EXTENSION CONNECTION BODY, HOWEVER, AFTER X-RAY IMAGING WAS PERFORMED IT WAS REVEALED THAT THE LEAD EXTENSIONS HAD MOVED AND WERE BROKEN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. THE HIGH IMPEDANCES WERE RESOLVED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SPECIFIC ISSUE THE PATIENT EXPERIENCED WAS RAPID JERKING MOVEMENTS OF THE RIGHT SHOULDER INCREASED AND PAIN IN THE LEFT POSTERIOR THIGH. THE SERIAL NUMBERS AND IMPLANT DATES OF THE LEAD EXTENSIONS WERE OBTAINED. IT WAS ALSO NOTED THAT NO CLEAR FRACTURES WERE VISIBLE ON THE LEAD EXTENSIONS IN THE X-RAY IMAGING.

  Patient problems: Dyskinesia; Movement Disorder; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24628749 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION (DBS) REVISION PROCEDURE, THE PATIENT EXPERIENCED A SENSATION OF TUGGING IN THE NECK AT THE SITE WHERE THE EXTENSIONS TRAVERSE. THE PHYSICIAN SUBSEQUENTLY PERFORMED A REPOSITIONING PROCEDURE TO RELIEVE TENSION AND LOOSEN THE WIRES IN THE PATIENT'S NECK. POSTOPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED. THE DEVICE REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Discomfort

  MAUDE report 24537266 ↗
• InjuryFeb 26, 2026Fracture; High impedance

  DURING A DEEP BRAIN STIMULATION (DBS) PROCEDURE, HIGH IMPEDANCES WERE IDENTIFIED ON BOTH OF THE PATIENTS LEADS. MULTIPLE TROUBLESHOOTING STEPS WERE ATTEMPTED; HOWEVER, THE ISSUE PERSISTED. THE PHYSICIAN DETERMINED THAT THE ELEVATED IMPEDANCES WERE ATTRIBUTABLE TO THE LEAD EXTENSIONS. THE PHYSICIAN MADE AN INCISION AT THE EXTENSION HEADER TO CHECK THE LEADS AND NOTICED ONE OF THE LEADS WAS BENT. BOTH LEAD EXTENSIONS WERE SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT RECOVERED WELL AND IS REPORTED TO BE IN GOOD CONDITION POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454136 ↗
• InjuryDec 23, 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 AT THE SITE OF THE LEAD EXTENSION RESULTING IN FEVERLIKE SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 23879680 ↗
• InjuryDec 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'S LEAD EXTENSION PROTRUDED THROUGH THE SKIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PHYSICIAN DID NOT WANT TO RISK AN INFECTION THEREFORE; THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE DBS SYSTEM. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THE LOCAL REPRESENTATIVE WAS NOT PRESENT FOR THE PROCEDURE TO RETRIEVE THEM.

  Patient problems: Perforation

  MAUDE report 23751532 ↗
• InjuryNov 27, 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 DISCHARGE AND EXTRUSION OF THE LEAD EXTENSION AT THE SCALPS IMPLANT SITE. THE PHYSICIAN WAS THOUGHT TO BELIEVE THAT PATIENT SLEEPING ON THE RIGHT SIDE AND POTENTIAL INJURY FROM GETTING SHORT HAIRCUTS CONTRIBUTED TO REPORTED EVENT. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD EXTENSIONS WERE REMOVED DUE TO CONCERNS OF INFECTION. CULTURES WERE TAKEN HOWEVER THE RESULTS ARE NOT AVAILABLE. ANALYSIS OF THE LEAD EXTENSIONS WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT WAS PRESCRIBED ANTI-BIOTICS AND DID WELL POST-OPERATIVELY.

  Patient problems: Erosion; Fluid Discharge

  MAUDE report 23667710 ↗
• InjuryNov 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS SCHEDULED FOR A MAGNETIC RESONANCE IMAGING (MRI) SCAN. AS PART OF THE PRE-MRI SAFETY PROTOCOL, IMPEDANCE TESTING WAS CONDUCTED, REVEALING THAT CONTACT 8 WAS OUTSIDE THE ACCEPTABLE RANGE. THIS FINDING PROMPTED A REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED COMPONENT WAS SUBSEQUENTLY DISCARDED BY THE HOSPITAL AND WAS NOT RETURNED FOR FURTHER ANALYSIS OR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501335 ↗
• InjurySep 23, 2025High impedance; Appropriate Device Problem Term/Code Not Available; High impedance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SLIGHT REDUCTION IN TREATMENT EFFICACY AND HIGH IMPEDANCES WERE DISCOVERED OVER A WIDESPREAD AREA. THERE WAS NO ISSUE OBSERVED WITH THE LEADS; IT WAS DETERMINED THAT THE LEAD EXTENSIONS WERE THE CAUSE OF THE IMPEDANCE READINGS. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEAD EXTENSIONS WERE REPLACED. FOLLOWING REPLACEMENT, THE IMPEDANCES RETURNED TO WITHIN A NORMAL RANGE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Shaking/Tremors

  MAUDE report 23129291 ↗
• InjurySep 19, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 23102292 ↗
• InjurySep 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD EXTENSION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REPOSITIONED. THE LEAD EXTENSION ON THE RIGHT SIDE OF THE NECK HAD BECOME LOOPED AND IN AN ATTEMPT TO PREVENT IT FROM ERODING THROUGH THE SKIN THE PHYSICIAN DECIDED TO REPOSITION IT. NO DEVICES WILL BE RETURNED FOR ANALYSIS AS THEY ALL REMAIN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048230 ↗
• InjurySep 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IT WAS DISCOVERED THAT THE LEAD EXTENSION WIRES WERE TWISTED UP IN THE POCKET OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD EXTENSIONS WERE REPLACED AND THE HIGH IMPEDANCES RESOLVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD EXTENSIONS WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983685 ↗
• InjuryAug 22, 2025High impedance; Appropriate Device Problem Term/Code Not Available; High impedance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LACK OF EFFICACY WITH THE THERAPY. IT WAS DISCOVERED THROUGH EXAMINATION OF THE DEVICE HARDWARE THAT THERE WERE HIGH IMPEDANCE MEASUREMENTS ON THE LEAD EXTENSIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE INITIAL IMPLANT DATE AND EXPLANT DATE OF THE LEAD EXTENSIONS WAS ALSO PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22873546 ↗
• InjuryAug 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, HIGH IMPEDANCES WERE IDENTIFIED ON THE DEEP BRAIN STIMULATION (DBS) DEVICE. CLINICAL EVALUATION INDICATED THAT SCAR TISSUE HAD FORMED AROUND THE LEAD EXTENSIONS, CAUSING BOWSTRINGING AND RESULTING IN CERVICAL SPINE DISCOMFORT DUE TO REDUCED RANGE OF MOTION. THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE LEAD EXTENSIONS, WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Discomfort; Scar Tissue

  MAUDE report 22709252 ↗
• InjuryJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES. IT WAS DISCOVERED THAT THE LEAD EXTENSIONS WERE TWISTED IN THE POCKET OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680805 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED POST-OPERATIVE HEALING COMPLICATIONS, INCLUDING TISSUE EROSION AT THE INCISION SITE LOCATED BEHIND THE LEFT EAR. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A REVISION PROCEDURE HAS BEEN PLANNED, AND THE EVENT REMAINS ONGOING AND UNDER CLINICAL ASSESSMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH THE EXTENSION PROTRUDING FROM THE SKIN. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEFT EXTENSION AND ASSOCIATED IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. A NEW EXTENSION WAS IMPLANTED AND CONNECTED TO AN EXISTING IPG.

  Patient problems: Erosion; Impaired Healing; Wound Dehiscence

  MAUDE report 22668564 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION, ACCOMPANIED BY FLUID LEAKAGE AT THE LEAD EXTENSION SITE SHORTLY AFTER THE PROCEDURE. A CULTURE WAS OBTAINED, BUT THE RESULTS REMAIN UNAVAILABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SUBSEQUENTLY UNDERWENT AN EXPLANT PROCEDURE. POSTOPERATIVE RECOVERY HAS BEEN FAVORABLE. THE IMPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE SUBMITTED FOR ANALYSIS.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 22664025 ↗

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