FDA Adverse Event
Injury
Summary report: N
VERCISE CARTESIA
MDR report key: 17063526
·
Received June 5, 2023
Report
- Report Number
- 3006630150-2023-03179
- Event Type
- Injury
- Date Received
- June 5, 2023
- Date of Event
- December 22, 2021
- Report Date
- June 5, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729905288
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), LOT: 523962. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C, MODEL: DB-4600C, SERIAL: NA, LOT: 28262142. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), LOT: 7090774 AND 7090059.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY. THE PHYSICIAN ASSESSED THAT THE LEAD WAS MISPLACED DURING THE IMPLANT PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING FINE POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021763 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-2202-45 | 7085818 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention |