FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 2780673
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-13244
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 18, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) INDICATED THAT THE PATIENT HAD ENTERED INTO HOSPICE AND THE DEVICE WAS PROGRAMMED TO MONITOR ONLY. NO FURTHER INTERVENTION WAS REPORTED TO HAVE BEEN PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.
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 | 73 YR | 1581| 4088| T127| 1488TC |