Vercise™ DB-9218-15Recalls & reported problems
Boston Scientific Neuromodulation Corporation · M8 Adapter, 15cm · Class 3 · Implant
Quick summary
This Boston Scientific Vercise adapter is part of an implanted system for deep brain stimulation. Reports mostly describe loss or weakening of stimulation linked to high electrical resistance, with return of tremors or other symptoms and replacement of the adapter. There are 26 reports, with no deaths and 23 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729905196), received between Mar 29, 2018 and Jan 15, 2026 — classified as 22 injuries, 3 malfunctions.
The most frequently reported specific device problem is “High impedance” (17 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.
Reports received per month
Most reported problems
Device problems
- High impedance17
- Adverse Event Without Identified Device or Use Problem5
- Unexpected Therapeutic Results4
- Appropriate Device Problem Term/Code Not Available2
- Charging Problem1
- Fracture1
- Premature Elective Replacement Indicator1
- Structural Problem1
Patient problems
- No Code Available6
- Movement Disorder5
- No Clinical Signs, Symptoms or Conditions4
- Bacterial Infection2
- Inadequate Pain Relief2
- Shaking/Tremors2
- Undesired Nerve Stimulation2
- Fall1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A JOLTING SENSATION AFTER HELPING HER SPOUSE UP FROM A FALL. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH AN M8 ADAPTER WAS EXPLANTED AND REPLACED. THE PATIENTS DBS DEVICE WAS REPROGRAMMED POSTOPERATIVELY AND THE CURRENT SETTINGS WERE SATISFACTORY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 24090272 ↗InjuryJul 14, 2025High impedance; High impedance
IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT, IMPLANTED WITH A NON-BOSTON SCIENTIFIC LEAD AND LEAD EXTENSIONS, EXPERIENCED A FALL THAT RESULTED IN HIGH IMPEDANCES READINGS. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE, DURING WHICH BOTH THE LEAD EXTENSION AND THE ADAPTER WERE REPLACED. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE ADAPTOR WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.
Patient problems: Fall
MAUDE report 22495840 ↗InjuryDec 4, 2024High impedance; High impedance
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING TREMORS ON HIS RIGHT HAND DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR ADAPTER WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE WAS DISCARDED.
Patient problems: Shaking/Tremors
MAUDE report 20850199 ↗InjuryDec 4, 2024High impedance; Premature Elective Replacement Indicator; High impedance; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT RECEIVED THE ELECTIVE REPLACEMENT INDICATOR MESSAGE ON THE IMPLANTABLE PULSE GENERATOR (IPG). DURING THE ELECTIVE REPLACEMENT PROCEDURE, HIGH IMPEDANCES WERE MEASURED WITH THE NEW IPG. THE PHYSICIAN REPLACED THE TWO LEAD ADAPTERS, AND THE IMPEDANCES RESOLVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED IPG AND LEAD ADAPTERS WERE DISPOSED AT THE HOSPITAL AND WERE NOT RETURNED TO BSC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846609 ↗InjuryAug 9, 2024High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE LOSS OF THERAPY FROM THEIR DEEP BRAIN STIMULATION (DBS) SYSTEM. IT WAS NOTED THAT A HIGH IMPEDANCE ON THE LEFT DBS LEAD EXTENSION WAS DISCOVERED ON CONTACT TWO, HOWEVER THE REASON FOR HIGH IMPEDANCE IS UNKNOWN. ATTEMPTS TO REPROGRAM THE DBS SYSTEM WERE MADE HOWEVER WERE UNSUCCESSFUL. X-RAY IMAGES WERE TAKEN IN THE FIELD HOWEVER THE RESULTS ARE UNAVAILABLE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED WITH ANOTHER OF THE SAME MODEL, HOWEVER IT IS UNKNOWN WHICH LED EXTENSION IS IN QUESTION, THEREFORE ARE REPORTING ON BOTH LEAD EXTENSIONS. PHYSICAL ANALYSIS OF THE DBS LEAD EXTENSION WAS NOT PERFORMED AS IT WAS NOT RELEASED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.
Patient problems: Movement Disorder
MAUDE report 19956547 ↗InjuryApr 29, 2024High impedance; High impedance
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A M8 ADAPTER REPLACEMENT DUE TO HIGH IMPEDANCE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202970 ↗MalfunctionMar 26, 2024High impedance; High impedance
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED M8 LEAD ADAPTER AND CONFIRMED THE EVENT OF THE PATIENT EXPERIENCING HIGH IMPEDANCES. X-RAY INSPECTION REVEALED THAT THE SECOND LEAD CONTACT WAS FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD EXTENSION BODY AND CONNECTOR SECTION OF THE LEAD EXTENSION. BENDING THE DISTAL END COULD ALSO CAUSE CABLE FRACTURES IN THE CONNECTOR SECTION OF THE LEAD EXTENSION. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE CONNECTOR. IT WAS NOTED THAT THE RETURNED M8 ADAPTER WAS NEVER IMPLANTED DUE TO HIGH IMPEDANCES DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE AND A DIFFERENT M8 ADAPTER WAS IMPLANTED INSTEAD. THERE WERE NO PATIENT COMPLICATIONS DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978912 ↗InjuryNov 29, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE RETURN OF THEIR PREEXISTING TREMORS DUE TO AN UNRELATED PROCEDURE WHICH MAY HAVE CAUSED THE ADAPTERS TO NOT FUNCTION PROPERLY. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO ADAPTERS OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WERE REPLACED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE NOT RELEASED BY THE FACILITY.
Patient problems: Shaking/Tremors
MAUDE report 18224525 ↗InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN (B)(6) STUDY EXPERIENCED A MODERATE WORSENING OF PARKINSON SYMPTOMS OF RIGIDITY AND BRADYKINESIA ON THE RIGHT SIDE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE DBS POCKET ADAPTERS WERE REPLACED. THE EVENT HAS RESOLVED.
Patient problems: Movement Disorder
MAUDE report 17221507 ↗InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH PUSS AND REDNESS NEAR THE DEEP BRAIN STIMULATION LEAD ADAPTER SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE INFECTED SITE WAS IRRIGATED AND CLEANED. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS AND WAS DOING WELL POST OPERATIVELY. THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED AN INFECTION AND EROSION BEHIND THE EAR AT THE NON-BOSTON SCIENTIFIC LEAD EXTENSION SITE. THE PATIENT THEN UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS RECOVERING POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.
Patient problems: Bacterial Infection; Purulent Discharge
MAUDE report 16218843 ↗InjuryDec 22, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT, WHO WAS IMPLANTED WITH A NON-BOSTON SCIENTIFIC LEAD AND BOSTON SCIENTIFIC DEEP BRAIN STIMULATOR LEAD ADAPTOR HAD ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS ASSESSED THAT THE ABNORMALITY WAS IN THE NON-BOSTON SCIENTIFIC LEAD EXTENSION, AND THEREFORE THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD EXTENSION WAS REPLACED. THE IMPEDANCES WERE CHECKED DURING THE OPERATION, AND IT WAS DISCOVERED THAT THERE WERE NO ABNORMALITIES WITH THE NON-BOSTON SCIENTIFIC LEADS OR EXTENSIONS. THE PHYSICIAN REPLACED THE BOSTON SCIENTIFIC ADAPTOR, AND AFTER DOING SO, THE IMPEDANCE RETURNED TO NORMAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN ASSESSED THE EVENT COULD POSSIBLY BE DUE TO THE MEDICAL ADHESIVE APPLIED ON THE INSERTION PORT OF THE M8 LEAD ADAPTER DURING THE IMPLANT PROCEDURE; THE ADHESIVE MAY HAVE EITHER PEELED AWAY OR HAD BEEN APPLIED TOO THINLY THUS LEADING TO FLUID ENTERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16040387 ↗InjuryDec 13, 2022High impedance; High impedance
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE M8 ADAPTERS AFTER THE PATIENT UNDERWENT AN UNRELATED PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG POCKET WAS OPENED AND THE M8 ADAPTERS WERE REPLACED. THE HIGH IMPEDANCES RESOLVED AND THE PATIENT IS DOING WELL POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 15966752 ↗InjuryDec 9, 2022High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN CLINICAL STUDY A4010 DEVELOPED WORSENING OF PARKINSON'S SYMPTOMS ON THE RIGHT SIDE WHICH WERE MODERATE IN SEVERITY. HIGH IMPEDANCE MEASUREMENTS WERE DISCOVERED ON THE DBS POCKET ADAPTOR. THE PATIENT WAS ADMITTED THE SAME DAY AND THE DEVICE WAS REPROGRAMMED AND THEN PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERING. THIS EVENT WAS REPORTED AS A CAUSAL RELATIONSHIP TO STIMULATION AND HARDWARE.
Patient problems: Movement Disorder
MAUDE report 15950666 ↗InjuryDec 2, 2022High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN CLINICAL STUDY A4010 DEVELOPED MODERATE WORSENING OF PARKINSON'S SYMPTOMS ON THE LEFT SIDE. HIGH IMPEDANCE MEASUREMENTS WERE DISCOVERED ON THE DBS POCKET ADAPTOR. THE PATIENT WAS TREATED WITH MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE EVENT RESOLVED ON 11 OCT 2022. THIS EVENT WAS REPORTED AS A CAUSAL RELATIONSHIP TO STIMULATION AND HARDWARE.
Patient problems: Movement Disorder
MAUDE report 15905893 ↗InjuryDec 2, 2022High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN CLINICAL STUDY A4010 DEVELOPED MODERATE WORSENING OF PARKINSON'S SYMPTOMS ON THE LEFT SIDE. HIGH IMPEDANCES MEASUREMENTS WERE DISCOVERED ON THE DBS POCKET ADAPTOR. THE PATIENT WAS TREATED WITH MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE EVENT RESOLVED (B)(6) 2022. THIS REPORTED EVENT HAS A CAUSAL RELATIONSHIP TO STIMULATION AND HARDWARE.
Patient problems: Movement Disorder
MAUDE report 15904862 ↗InjuryJul 27, 2021High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEAD CONTACTS 1 AND 9 AND UNDESIRED SENSATIONS IN A NON-TARGET STIMULATION AREA ON HER BACK. THE PATIENT HAS BOTH BOSTON SCIENTIFIC LEAD ADAPTERS AND A COMPETITOR'S LEADS IMPLANTED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE TWO ADAPTERS WERE EXPLANTED AND REPLACED. AFTER THE ADAPTERS WERE REPLACED, THE HIGH IMPEDANCE ISSUE WAS RESOLVED. THE PHYSICIAN NOTED THAT THE FIRST CONTACT ON BOTH ADAPTERS WERE BROKEN. THE PATIENT IS DOING WELL POSTOPERATIVELY AND HAS FULLY RECOVERED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 12229987 ↗InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED FALL THAT RESULTED IN A WOUND NEAR THE PATIENT'S NON-BOSTON SCIENTIFIC BURR HOLE COVER. THE PATIENT DEVELOPED AN INFECTION AT THE NON-BOSTON SCIENTIFIC BURR HOLE COVER, LEAD, LEAD EXTENSION AND THE BOSTON SCIENTIFIC M8 LEAD ADAPTER SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHERE THE BOSTON SCIENTIFIC LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC DEVICES WERE REMOVED. DURING THE PROCEDURE, A SWAB WAS TAKEN AT THE BOSTON SCIENTIFIC IPG SITE AND IT WAS ALSO FOUND TO BE POSITIVE FOR AN INFECTION. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE WHERE THE IPG WAS EXPLANTED. THE PATIENT WAS STABLE POST-OPERATIVELY. THE EXPLANTED M8 ADAPTER AND IPG WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICES WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT A SECOND LEAD EXTENSION WAS ALSO EXPLANTED. THE PATIENT WAS HEALING WELL POST-OPERATIVELY.
Patient problems: Bacterial Infection
MAUDE report 11627296 ↗InjuryNov 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO SWITCH FROM A NON-BSC IMPLANTABLE PULSE GENERATOR (IPG) TO A BSC IPG. DURING THE IMPLANT PROCEDURE, M8 ADAPTORS WERE IMPLANTED TO CONNECT THE EXISTING NON-BSC LEADS TO THE NEW BSC IPG. AN IMPEDANCE CHECK SHOWED APPROPRIATE CONNECTIVITY SO THE CONNECTION WAS SECURED AND THE PATIENT WAS SUTURED. A SECOND IMPEDANCE CHECK SHOWED HIGH IMPEDANCES. THE PHYSICIAN RE-OPENED THE SUB CLAVICULAR POCKET AND REPLACED THE M8 ADAPTORS, HOWEVER, THE HIGH IMPEDANCES REMAINED. THE PHYSICIAN DECIDED TO KEEP THE SYSTEM IMPLANTED AS THEY COULD PROGRAM EFFECTIVE THERAPY USING THE NORMAL IMPEDANCE CONTACTS.
Patient problems: No Code Available
MAUDE report 10863155 ↗InjuryJun 16, 2020High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING STIMULATION. IT WAS FOUND THAT THE ADAPTOR HAD HIGH IMPEDANCES ON EACH CONTACT. PATIENT UNDERWENT A REVISION TO REPLACE THE ADAPTOR AND IS DOING WELL POST-OPERATIVELY.
Patient problems: No Code Available
MAUDE report 10160086 ↗InjuryJun 16, 2020Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE M8 LEAD ADAPTOR. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE M8 LEAD ADAPTOR WAS REPLACED. THE PROCEDURE WAS COMPLETED AND THE IMPEDANCE VALUES WERE WITHIN THE NORMAL RANGE.
Patient problems: No Code Available
MAUDE report 10159785 ↗InjuryFeb 28, 2020Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IPG WAS SHOWING TWO HIGH IMPEDANCES ON TWO THERAPEUTIC CONTACTS, AND IT WAS CAUSING INADEQUATE STIMULATION FOR THE PATIENT. THE STIMULATION WAS TURNED OFF AS THE PHYSICIAN OPENED PATIENT UP AT THE HEAD SITE TO TEST THE LEAD, AND POCKET SITE TO TEST THE EXTENSION AND ADAPTORS. PHYSICIAN ASSESSED ONE OF THE ADAPTERS WAS BROKEN. HE REPLACED THE BROKEN ADAPTOR WITH A NEW ONE. THE PATIENT WAS DOING GOOD POST OPERATIVELY AND RECEIVING GOOD STIMULATION COVERAGE. ADDITIONAL INFORMATION WAS RECEIVED WHEN THE DEVICE WAS RETURNED ON 07APR2020 THAT THE SERIAL NUMBER OF THE EXPLANTED DEVICE IS (B)(6) AND NOT (B)(6) THAT WAS REPORTED IN THE INITIAL VIGILANCE REPORT.
Patient problems: Inadequate Pain Relief; No Code Available
MAUDE report 9771006 ↗InjuryFeb 1, 2019High impedance; High impedance
A REPORT WAS RECEIVED THAT HIGH IMPEDANCES WERE OBSERVED BEFORE COMPLETING IPG IMPLANTATION. THE PHYSICIAN ATTEMPTED TO WIPE THE ELECTRODE WITH GAUZE, BUT HIGH IMPEDANCE ISSUE WAS NOT RESOLVED. IT WAS DECIDED AT THAT TIME TO REPLACE THE LEAD WITH ANOTHER OF THE SAME PRODUCT. PATIENT IS DOING WELL POST OPERATIVELY.
Patient problems: No Code Available
MAUDE report 8298018 ↗MalfunctionNov 7, 2018High impedance; Charging Problem; High impedance; Charging Problem
A REPORT WAS RECEIVED THAT A PATIENT'S LEAD ADAPTERS WERE EXPLANTED DUE TO HIGH IMPEDANCES. THE PATIENT'S IPG WAS ALSO EXPLANTED DUE TO FREQUENT CHARGING. AFTER THE REPLACEMENT PROCEDURE, THE IMPEDANCES WERE NORMAL.
Patient problems: No Code Available
MAUDE report 8049102 ↗MalfunctionMay 1, 2018High impedance; High impedance
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IMPEDANCE ISSUES ON ONE ELECTRODE OF THE M8 ADAPTER. THE PHYSICIAN REPLACED THE ADAPTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7478112 ↗InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED STIFFNESS AND NUMBNESS IN THE LEFT ARM AND A LIGHT WOULD APPEAR IN FRONT OF THE PATIENTS EYE WHEN DRIVING A CAR WHILE BACKING UP. IN ADDITION, THE PHYSICIAN SUSPECTED A SIMPLE FRACTURE WAS CAUSING HIGH IMPEDANCES. THE PATIENT WAS HOSPITALIZED AND UNDERWENT AN EXPLANT PROCEDURE WHERE THE M8 ADAPTER AND IPG WERE REMOVED. WHEN THE M8 ADAPTER WAS REMOVED, THE IMPEDANCES DISAPPEARED. THE PHYSICIAN ASSESSED THAT THE SYMPTOMS OF ARM STIFFNESS AND LIGHT APPEARING IN THE EYE MAY BE DUE TO THE PATIENT DISEASE.
Patient problems: Muscular Rigidity; Numbness; Visual Impairment
MAUDE report 7384240 ↗
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-2340-2025 · Jul 8, 2025 · Open, ClassifiedBurr 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-2558-2025 · Jul 8, 2025 · Open, ClassifiedVercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
- Z-1890-2024 · Apr 18, 2024 · Open, ClassifiedVercise 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 · TerminatedFifty-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
Other Stimulator, electrical, implanted, for essential tremor devices
- Vercise Genus™ DB-1216Boston Scientific Neuromodulation Corporation · Stimulator, electrical, implanted, for essential tremor2 recalls23 deaths584 reports
- Liberta RC™ 62400Advanced Neuromodulation Systems, Inc. · Stimulator, electrical, implanted, for essential tremor2 recalls1 death103 reports
- SureTek™ DB-4600-CBoston Scientific Neuromodulation Corporation · Stimulator, electrical, implanted, for essential tremor1 recall138 reports
- Activa® SC 37603Medtronic, Inc. · Stimulator, electrical, implanted, for essential tremor1 recall111 reports
- Activa® SC 37602Medtronic, Inc. · Stimulator, electrical, implanted, for essential tremor1 recall85 reports
- SenSight™ B3301542Medtronic, Inc. · Stimulator, electrical, implanted, for essential tremor3 deaths77 reports
- N/A 3708660Medtronic, Inc. · Stimulator, electrical, implanted, for essential tremor43 reports
- SenSight™ B3301542MMedtronic, Inc. · Stimulator, electrical, implanted, for essential tremor3 deaths43 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.