VERCISE GENUS
Report
- Report Number
- 3006630150-2025-00273
- Event Type
- Injury
- Date Received
- January 29, 2025
- Date of Event
- December 19, 2024
- Report Date
- January 29, 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
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL/BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL/BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL/BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL/BATCH: (B)(6).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RIGHT PARIETAL INCISION INFECTION WHEREIN THERE WAS A DELAY IN WOUND HEALING AND DRAINAGE PRESENTING AT THE SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. CULTURE TAKEN WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. 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 |
|---|---|---|---|---|---|---|---|
| 467707 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 597727 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |