VERCISE GEVIA
Report
- Report Number
- 3006630150-2021-02057
- Event Type
- Injury
- Date Received
- May 12, 2021
- Date of Event
- April 27, 2021
- Report Date
- July 29, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
BLOCK A2: DATE OF BIRTH: YEAR OF BIRTH IS 1967 EXACT DATE IS UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7072985 AND 7072932. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550 X2. MODEL: NM-3138-55 X2. SERIAL: (B)(6) AND UNKNOWN. BATCH: 7072834, AND UNKNOWN.
BLOCK A2: DATE OF BIRTH: YEAR OF BIRTH IS 1967 EXACT DATE IS UNKNOWN ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7072985 AND 7072932. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550 X2; MODEL: NM-3138-55 X2; SERIAL: (B)(6); BATCH: 7072834 AND 7072964.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3138550 MODEL: DB-3138-55 SERIAL: UNKNOWN (2) BATCH: UNKNOWN (2)
IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE VERCISE DBS REGISTRY CLINICAL STUDY, WAS ADMITTED DUE TO DEHISCENCE OF THE SURGICAL WOUND WHICH WAS MODERATE IN SEVERITY. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE DEVICE. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE IPG, IMPLANTABLE PULSE GENERATOR, TWO LEADS, AND TWO LEAD EXTENSIONS WERE EXPLANTED DUE TO AN INFECTION IN THE LEFT PARIETAL REGION WHICH WAS MODERATE IN SEVERITY. CULTURES WERE TAKEN AND REVEALED MSSA, METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS, INFECTION. THE PATIENT WAS PRESCRIBED A SIX WEEK COURSE OF ANTIBIOTICS. THE EVENT IS RESOLVING, AND THE PATIENT IS RECOVERING. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY LABORATORY FOR MICRO BACTERIAL STUDY.
IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE VERCISE DBS REGISTRY CLINICAL STUDY, WAS ADMITTED DUE TO DEHISCENCE OF THE SURGICAL WOUND WHICH WAS MODERATE IN SEVERITY. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE DEVICE. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE IPG, IMPLANTABLE PULSE GENERATOR, TWO LEADS, AND TWO LEAD EXTENSIONS WERE EXPLANTED DUE TO AN INFECTION IN THE LEFT PARIETAL REGION WHICH WAS MODERATE IN SEVERITY. CULTURES WERE TAKEN AND REVEALED MSSA, METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS, INFECTION. THE PATIENT WAS PRESCRIBED A SIX WEEK COURSE OF ANTIBIOTICS. THE EVENT IS RESOLVING, AND THE PATIENT IS RECOVERING. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY LABORATORY FOR MICRO BACTERIAL STUDY.
IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE VERCISE DBS REGISTRY CLINICAL STUDY, WAS ADMITTED DUE TO DEHISCENCE OF THE SURGICAL WOUND WHICH WAS MODERATE IN SEVERITY. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE DEVICE. THE PATIENT DATE OF BIRTH YEAR IS 1967, THE EXACT DATE IS UNKNOWN. IT WAS SUBSEQUENTLY STATED THAT THE PATIENT UNDERWENT A REVISION AND EXPLANT PROCEDURE IN WHICH THE IPG, IMPLANTABLE PULSE GENERATOR, TWO LEADS, AND TWO LEAD EXTENSIONS WERE EXPLANTED DUE TO AN INFECTION IN THE LEFT PARIETAL REGION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE EVENT IS RESOLVING, AND THE PATIENT IS RECOVERING. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY LABORATORY FOR MICRO BACTERIAL STUDY.
IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE (B)(4) CLINICAL STUDY, WAS ADMITTED DUE TO DEHISCENCE OF THE SURGICAL WOUND WHICH WAS MODERATE IN SEVERITY. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE DEVICE. THE PATIENT DATE OF BIRTH YEAR IS (B)(4) THE EXACT DATE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707550 | VERCISE GEVIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | DB-1200 | 741715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |