FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 3223606
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-09908
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- March 21, 2013
- Report Date
- June 18, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
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 ATRIAL (RA) LEAD DISPLAYED OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE (PLI) MEASUREMENTS OF GREATER THAN 3000 OHMS. PACING THRESHOLDS WERE NOT ABLE TO BE OBTAINED. THE PATIENT WAS ASYMPTOMATIC. IT WAS REPORTED THAT THE LEAD WOULD LIKELY BE REVISED AT SOME POINT IN THE FUTURE. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322308 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | H219| 4086| 0181| 4525 |