VERCISE GEVIA
Report
- Report Number
- 3006630150-2020-01923
- Event Type
- Injury
- Date Received
- April 29, 2020
- Date of Event
- March 1, 2023
- Report Date
- August 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729984443
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THERE IS NO EVIDENCE THAT THE DEVICES WERE USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. NO FURTHER REVIEW IS REQUIRED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2202-45 (B)(6). DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM H3 OTHER TEXT : DEVICES WERE DISCARDED BY FACILITY
CORRECTION TO FIELD BSC AWARE DATE. THE CORRECT AWARE DATE IS 11OCT2021 AND NOT 17MAR2020 AS INITIALLY REPORTED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7073068. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7073170.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED FACIAL SWELLING AND HEADACHES. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD AN INFECTION AND PERFORMED A FULL SYSTEM EXPLANT. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE DEVICES WERE DISCARDED BY THE FACILITY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE HOSPITAL.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2202-45, SERIAL/ LOT: (B)(4), DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED FACIAL SWELLING AND HEADACHES. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD AN INFECTION AND PERFORMED A FULL SYSTEM EXPLANT. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE DEVICES WERE DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472906 | VERCISE GEVIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-1200-S | 737738 | 08714729984443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention |