VERCISE GEVIA
Report
- Report Number
- 3006630150-2021-06515
- Event Type
- Injury
- Date Received
- November 17, 2021
- Date of Event
- August 28, 2020
- Report Date
- June 27, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729984443
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 7062239. PRODUCT FAMILY: DBS-EXTENSION. UPN: DBS-EXTENSION. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7076705.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45 , SERIAL: (B)(4), BATCH: (B)(4).
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, AN INFECTION WHERE DISCHARGE APPEARED WAS DISCOVERED AT THE IMPLANTABLE PULSE GENERATOR IPG SITE. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. FOLLOWING THIS, THE PATIENT WAS LATER RE-IMPLANTED AND WAS DOING WELL.
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, AN INFECTION WHERE DISCHARGE APPEARED WAS DISCOVERED AT THE IMPLANTABLE PULSE GENERATOR IPG SITE. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. FOLLOWING THIS, THE PATIENT WAS LATER RE-IMPLANTED AND WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730047 | VERCISE GEVIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1200-S | 742998 | 08714729984443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Required Intervention |