VERCISE GENUS
Report
- Report Number
- 3006630150-2023-03296
- Event Type
- Injury
- Date Received
- June 10, 2023
- Date of Event
- May 19, 2023
- Report Date
- November 20, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729985044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: (B)(6).
IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A PROCEDURE WHERE PART OF THE DBS SYSTEM WAS REMOVED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A PROCEDURE WHERE PART OF THE DBS SYSTEM WAS REMOVED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH LEADS WERE ALSO INFECTED. CULTURES TAKEN WERE POSITIVE FOR COAGULASE V AND STAPHYLOCOCCUS AUREUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 452249 | VERCISE GENUS | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1216 | 542876 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |