VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-06173
- Event Type
- Injury
- Date Received
- August 5, 2025
- Date of Event
- January 9, 2025
- Report Date
- December 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO THE INITIAL MDR IN H6. 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-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7123530 UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7123584 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6). BATCH: 5001216 UDI: (B)(4).
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-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7123530, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7123584, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5001216, UDI: (B)(4).
IT WAS REPORTED THAT THESE DEEP BRAIN STIMULATION (DBS) DEVICES WERE EXPLANTED DUE TO A LOCALIZED INFECTION IN THE HEAD. THE PRIMARY SYMPTOM WAS PUSS DISCHARGE. ALTHOUGH THE EXACT CAUSE OF THE INFECTION REMAINS UNIDENTIFIED, CULTURES REVEALED THE PRESENCE OF BACTERIA BELONGING TO THE SERRATIA GENUS. THE PATIENT WAS SUBSEQUENTLY STARTED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS REVISION PROCEDURE WHEREIN THEIR DEVICES WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL. AFTER RECOVERING FROM THE EXPLANT PROCEDURE, THE PATIENT RECEIVED A NEW SYSTEM IMPLANT AND IS AWAITING THE PROGRAMMING APPOINTMENT.
IT WAS REPORTED THAT THESE DEEP BRAIN STIMULATION (DBS) DEVICES WERE EXPLANTED DUE TO A LOCALIZED INFECTION IN THE HEAD. THE PRIMARY SYMPTOM WAS PUSS DISCHARGE. ALTHOUGH THE EXACT CAUSE OF THE INFECTION REMAINS UNIDENTIFIED, CULTURES REVEALED THE PRESENCE OF BACTERIA BELONGING TO THE SERRATIA GENUS. THE PATIENT WAS SUBSEQUENTLY STARTED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS REVISION PROCEDURE WHEREIN THEIR DEVICES WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL. AFTER RECOVERING FROM THE EXPLANT PROCEDURE, THE PATIENT RECEIVED A NEW SYSTEM IMPLANT AND IS AWAITING THE PROGRAMMING APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2497733 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 596750 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |