VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-08235
- Event Type
- Injury
- Date Received
- October 2, 2025
- Date of Event
- August 28, 2025
- Report Date
- October 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5002460. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003272. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001310 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001267 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 35765310 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 35410440. UDI: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DRAINAGE IN THE SCALP AND CHEST ON THE RIGHT SIDE WHEREIN THE SITES WERE RED AND PAINFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278481 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1232 | 780251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |