VERCISE CARTESIA
Report
- Report Number
- 3006630150-2022-04175
- Event Type
- Injury
- Date Received
- August 23, 2022
- Date of Event
- July 22, 2022
- Report Date
- November 8, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729905288
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7092381.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7092381.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD PERI-LEAD EDEMA RELATED TO BOTH IMPLANTED LEADS. THEREFORE, THE PATIENT WAS TREATED WITH AN ORAL STEROID. THE EDEMA WAS ASSESSED TO BE CAUSALLY RELATED TO THE PROCEDURE, DEVICE, AND STIMULATION. THE PATIENT IS CURRENTLY RECOVERING.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD PERI-LEAD EDEMA RELATED TO BOTH IMPLANTED LEADS. THEREFORE, THE PATIENT WAS TREATED WITH AN ORAL STEROID. THE EDEMA WAS ASSESSED TO BE CAUSALLY RELATED TO THE PROCEDURE, DEVICE, AND STIMULATION. THE PATIENT IS CURRENTLY RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS CAUSALLY RELATED TO THE PROCEDURE AND THE HARDWARE, AND NOT RELATED TO THE STIMULATION.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD PERI-LEAD EDEMA RELATED TO BOTH IMPLANTED LEADS. THEREFORE, THE PATIENT WAS TREATED WITH AN ORAL STEROID. THE EDEMA WAS ASSESSED TO BE CAUSALLY RELATED TO THE PROCEDURE, DEVICE, AND STIMULATION. THE PATIENT IS CURRENTLY RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS CAUSALLY RELATED TO THE PROCEDURE AND THE HARDWARE, AND NOT RELATED TO THE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD EXPERIENCED MILD DROWSINESS THEREFORE, A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED AND HAD CONFIRMED THE PRESENCE OF MILD PERI-LEAD EDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2352872 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-2202-45 | 7092829 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |