FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 3052759
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05657
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- June 1, 2010
- Report Date
- March 6, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD HAD BEEN EXHIBITING INCREASING IMPEDANCE MEASUREMENTS SINCE IMPLANT. MOST RECENTLY, THE MEASUREMENT WAS 2200 OHMS. NO SENSING OR THRESHOLD ISSUES HAVE BEEN OBSERVED. THE PHYSICIAN IS AWARE AND INTENDS TO CONTINUE NORMAL FOLLOW UP VISITS FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155595 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | H219| 4086| 4524| 0181 |