VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-11375
- Event Type
- Injury
- Date Received
- December 11, 2025
- Date of Event
- November 28, 2025
- Report Date
- March 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985020
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CAUSE OF THE PATIENT RECEIVING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE DUE TO SUSPECTED PREMATURE BATTERY DEPLETION AND UNDERGOING A REVISION PROCEDURE COULD NOT BE CONFIRMED. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THE DEVICE INDICATED THAT IT WAS SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DEVICE HISTORY REVIEW, DHR, DID NOT IDENTIFY ANY MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DHR REVIEW ENSURES EACH DEVICE MEETS REQUIRED SPECIFICATIONS AND ASSOCIATED TESTING PRIOR TO RELEASE FOR DISTRIBUTION/SALE. DEVICE TECHNICAL ANALYSIS: THE DEVICES WERE DISCARDED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CAUSE OF THE PATIENT RECEIVING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE DUE TO SUSPECTED PREMATURE BATTERY DEPLETION AND UNDERGOING A REVISION PROCEDURE COULD NOT BE CONFIRMED BASED ON COMPLAINT REVIEW. THE DEVICE WASE DISCARDED BY THE FACILITY AND DEVICE ANALYSIS COULD NOT BE DONE. THE INVESTIGATION IS INCONCLUSIVE. THE MALFUNCTION OF THE DEVICE HAS NOT BEEN CONFIRMED.
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT EXPERIENCED A WORSENING OF THEIR PARKINSON'S MOTOR SYMPTOMS AND UNDERWENT A PROCEDURE IN WHICH THE IPG WAS REPLACED. IT WAS ADDITIONALLY REPORTED THAT REPROGRAMMING WAS COMPLETED, AND THAT THE PATIENT WAS A HIGH ENERGY USER, AND THAT HIGHER-THAN-NORMAL IMPEDANCES WERE IDENTIFIED, HOWEVER, THE PATIENT DID NOT EXPERIENCE INADEQUATE THERAPY. THE PATIENT IS DOING WELL POST OPERATIVELY AND HAS REGAINED THERAPY TO ADDRESS THEIR PRE-EXISTING PARKINSON'S DISEASE SYMPTOMS.
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT EXPERIENCED A WORSENING OF HEIR PARKINSON'S MOTOR SYMPTOMS AND UNDERWENT A PROCEDURE IN WHICH THE IPG WAS REPLACED.
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT EXPERIENCED A WORSENING OF HEIR PARKINSON'S MOTOR SYMPTOMS AND UNDERWENT A PROCEDURE IN WHICH THE IPG WAS REPLACED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT DID NOT UNDERGO A REVISION PROCEDURE AND THAT THE IPG REMAINS IMPLANTED. REPROGRAMMING HAS BEEN COMPLETED, AND THE PATIENT IS A HIGH ENERGY USER, AND THAT HIGHER-THAN-NORMAL IMPEDANCES WERE IDENTIFIED, HOWEVER, THE PATIENT HAS NOT EXPERIENCED INADEQUATE THERAPY.
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT EXPERIENCED A WORSENING OF THEIR PARKINSON'S MOTOR SYMPTOMS AND UNDERWENT A PROCEDURE IN WHICH THE IPG WAS REPLACED. IT WAS ADDITIONALLY REPORTED THAT REPROGRAMMING WAS COMPLETED, AND THAT THE PATIENT WAS A HIGH ENERGY USER, AND THAT HIGHER THAN NORMAL IMPEDANCES WERE IDENTIFIED, HOWEVER, THE PATIENT DID NOT EXPERIENCE INADEQUATE THERAPY. THE PATIENT IS DOING WELL POST OPERATIVELY AND HAS REGAINED THERAPY TO ADDRESS THEIR PRE-EXISTING PARKINSON'S DISEASE SYMPTOMS. IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2696283 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1416 | 228970 | 08714729985020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |