FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 1953839
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24129
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 10, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS INACTIVELY IMPLANTED. 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 PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE ON THE ELECTROGRAM WITH NO CAPTURE. THE LEAD WAS DIAGNOSED AS FRACTURE, HOWEVER, NO VISIBLE INJURY WAS FOUND. THE LEAD WAS CAPPED AND REPLACED WITHOUT COMPLICATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.
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 | 77 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |