FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1952776
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23791
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT SKIN EROSION AND INFECTION. INVESTIGATION IS CONSIDERED CLOSED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED DUE TO POCKET EROSION AND INFECTION. A NEW DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | S606| 4469| 1298| 4087 |