VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-09370
- Event Type
- Injury
- Date Received
- October 21, 2025
- Date of Event
- September 19, 2025
- Report Date
- January 2, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
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>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 7077422. UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 7080146. UDI: (B)(4)
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>.
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 THE DBS PATIENT UNDERWENT THE PROCEDURE DUE TO AN INFECTION INVOLVING NON-BOSTON SCIENTIFIC LEADS AND EXTENSIONS, BOSTON SCIENTIFIC ADAPTERS WERE ALSO EXPLANTED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY EXPLANTED, NO DEVICE RELATED CONCERNS WERE MADE. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE INFECTION REMAINS UNKNOWN. THE PATIENT WAS INITIATED ON ANTIBIOTIC, AND CULTURES WERE OBTAINED; HOWEVER, IT IS NOT POSSIBLE TO PROVIDE THE CULTURE RESULTS AT THIS TIME. POSTOPERATIVELY, THE PATIENT REMAINS STABLE.
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 THE DBS PATIENT UNDERWENT THE PROCEDURE DUE TO AN INFECTION INVOLVING NON-BOSTON SCIENTIFIC LEADS AND EXTENSIONS AND BOSTON SCIENTIFIC ADAPTERS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY EXPLANTED, NO DEVICE RELATED CONCERNS WERE MADE. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS RECOVERING.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309662 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 782918 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |