FDA Adverse Event
Injury
Summary report: N
VERCISE GENUS?
MDR report key: 23812784
·
Received December 15, 2025
Report
- Report Number
- 3006630150-2025-11454
- Event Type
- Injury
- Date Received
- December 15, 2025
- Date of Event
- November 21, 2025
- Report Date
- February 12, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985051
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE BLOCK D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <NHL, PJS>.
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE. BLOCK D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <NHL, PJS>.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A PARTIAL EXPLANT FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A PARTIAL EXPLANT FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1874822 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1232 | 529991 | 08714729985051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |