FDA Adverse Event
Injury
Summary report: N
VERCISE GENUS?
MDR report key: 23530087
·
Received November 12, 2025
Report
- Report Number
- 3006630150-2025-10286
- Event Type
- Injury
- Date Received
- November 12, 2025
- Date of Event
- September 1, 2025
- Report Date
- December 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985020
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.
Additional Manufacturer Narrative · 0
BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) REACHED END OF SERVICE, AND UNDERWENT AN IPG REPLACEMENT PROCEDURE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS' IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEEP BRAIN STIMULATION (DBS) REACHED END OF SERVICE, AND UNDERWENT AN IPG REPLACEMENT PROCEDURE. IT WAS ADDITIONALLY REPORTED THAT NO MALFUNTION WAS SUSPECTED, AND THAT THE PATIENT WAS DOING WELL POST OPERATIVELY. 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 |
|---|---|---|---|---|---|---|---|
| 1932124 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1416 | 210577 | 08714729985020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention |