FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 2905510
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-13751
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 3, 2012
- Report Date
- October 3, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 DURING A ROUTINE DEVICE REPLACEMENT, THIS RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO HAVE FRACTURED IN THE LOCATION WHERE THE LEAD WENT UNDERNEATH A SHOULDER BONE. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED AND ATRIAL THERAPY WAS PROGRAMMED OFF IN THE DEVICE DUE TO THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION (AF). NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10771 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | 1296| 4086| 4087 |