FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2173650
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11391
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT NOTED THAT THIS RIGHT VENTRICULAR (RV) LEAD "WENT BAD" AND WAS REPLACED APPROXIMATELY SIX MONTHS AGO. IT WAS NOTED THAT THE SPECIFIC LEAD ISSUE WAS UNKNOWN; HOWEVER, THERE HAD BEEN ELEVATED THRESHOLDS AND INTERMITTENT LOSS OF RV CAPTURE. THE PATIENT REPORTED THAT THEY HAD NO ADVERSE EFFECTS RELATED TO THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | 1291| 4470| 4088 |