FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2161567
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07255
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, AS WELL AS A SYNCOPAL EVENT AND SHORTNESS OF BREATH. IT IS BELIEVED THAT DURING A RECENT THRESHOLD TEST ON THE ATRIAL (RA) LEAD, THE DEVICE'S AUTOMATIC CAPTURE PROGRAMMING KICKED IN AND PACED WHEN IT SHOULDN'T HAVE. DOING THIS CAUSED SOME DESYNCHRONY FROM THE ATRIUM TO THE VENTRICLE. THE DECISION WAS MADE TO REPLACE THE RV LEAD. AT EXPLANT, THE RV LEAD WAS FOUND TO BE FRACTURED. BOTH THE RA AND RV LEAD WERE SURGICALLY ABANDONED AND THE DEVICE WAS REPLACED.
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 | 90 YR | Life Threatening| R | 4087| 4136| 1290| 4086| 4135| S403 |