VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-06989
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- August 5, 2025
- Report Date
- October 27, 2025
- 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
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS DBS DEVICE WAS REPLACED DUE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS DBS PATIENT WAS A HIGH FREQUENCY USER.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS DBS DEVICE WAS REPLACED DUE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2131318 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1416 | 219621 | 08714729985020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |