VERCISE CARTESIA
Report
- Report Number
- 3006630150-2022-07537
- Event Type
- Injury
- Date Received
- January 6, 2023
- Date of Event
- December 5, 2022
- Report Date
- May 8, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729905271
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: (B)(4).
CORRECTION TO FIELD B2 - ADDED HOSPITALIZATION AS IT WAS NOT INCLUDED IN THE INITIAL REPORT AS IT SHOULD HAVE BEEN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7078508.
CORRECTION TO FIELD B2 - ADDED HOSPITALIZATION AS IT WAS NOT INCLUDED IN THE INITIAL REPORT AS IT SHOULD HAVE BEEN, 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).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING PERIFOCAL ELECTRODE EDEMA FOLLOWING A LEAD IMPLANT PROCEDURE WHEREIN CAUSING AN EPILEPTIC EPISODE. CT IMAGING WAS PERFORMED AND CONFIRMED EDEMA. STIMULATION WAS TURNED OFF AND THE PATIENT WAS HOSPITALIZED AND EDEMA REGRESSION CORTISON THERAPY WAS ADMINISTERED AND THE PATIENT WAS IMPROVING.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING PERIFOCAL ELECTRODE EDEMA FOLLOWING A LEAD IMPLANT PROCEDURE WHEREIN CAUSING AN EPILEPTIC EPISODE. COMPUTED TOMOGRAPHY SCAN (CT) IMAGING WAS PERFORMED AND CONFIRMED EDEMA. STIMULATION WAS TURNED OFF AND THE PATIENT WAS HOSPITALIZED AND EDEMA REGRESSION CORTISON THERAPY WAS ADMINISTERED AND THE PATIENT WAS IMPROVING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS ALSO ADMINISTERED ANTICONVULSANT THERAPY. AN EEG EXAMINATION WAS ABNORMAL BUT DID NOT SHOW ELECTROGRAPHIC SEIZURE ACTIVITY. THE RELATIONSHIP TO THE DEVICE WAS REPORTED AS PROBABLE SPECIFICALLY TO THE LEADS AND UNLIKELY RELATED TO THE PROCEDURE. THE EVENT HAS BEEN REPORTED AS RECOVERED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS EXPERIENCING PERIFOCAL ELECTRODE EDEMA FOLLOWING A LEAD IMPLANT PROCEDURE WHEREIN CAUSING AN EPILEPTIC EPISODE. COMPUTED TOMOGRAPHY SCAN (CT) IMAGING WAS PERFORMED AND CONFIRMED EDEMA. STIMULATION WAS TURNED OFF AND THE PATIENT WAS HOSPITALIZED AND EDEMA REGRESSION CORTISON THERAPY WAS ADMINISTERED AND THE PATIENT WAS IMPROVING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS ALSO ADMINISTERED ANTICONVULSANT THERAPY. AN EEG EXAMINATION WAS ABNORMAL BUT DID NOT SHOW ELECTROGRAPHIC SEIZURE ACTIVITY. THE RELATIONSHIP TO THE DEVICE WAS REPORTED AS PROBABLE SPECIFICALLY TO THE LEADS AND UNLIKELY RELATED TO THE PROCEDURE. THE EVENT HAS BEEN REPORTED AS RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SPECIFIC TYPE OF EDEMA THE PATIENT EXPERIENCED WAS CEREBRAL OEDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438624 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-2202-30 | 7078393 | 08714729905271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention| H |