FDA Adverse Event
Injury
Summary report: N
VERCISE CARTESIA
MDR report key: 18049859
·
Received November 1, 2023
Report
- Report Number
- 3006630150-2023-06704
- Event Type
- Injury
- Date Received
- November 1, 2023
- Date of Event
- October 16, 2023
- Report Date
- November 1, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NHL
- UDI-DI
- 08714729905288
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7111294.
Description of Event or Problem · 0
IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION (DBS) LEAD IMPLANT PROCEDURE, A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO VIEW THE PLACEMENT OF THE LEADS AND IT WAS CONFIRMED THAT THE LEADS HAD PULLED BACK. IT WAS DETERMINED THAT THE LEADS WERE VERY DORSAL TO THEIR TARGETED LOCATION. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2141307 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION | DB-2202-45 | 7097562 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention |