FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 2161302
·
Received July 13, 2011
Report
- Report Number
- 2124215-2011-07267
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- September 1, 2007
- Report Date
- April 14, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 CLINICIAN STATED THE DEVICE WAS PROGRAMMED TO PACE IN THE VENTRICLE ONLY AS THE RIGHT ATRIAL (RA) LEAD HAD FRACTURED THREE AND A HALF YEARS EARLIER. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD FRACTURE. THE LEAD REMAINS IMPLANTED IN THE PATIENT.
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 | 98 YR | 4035| 1280| 4087 |