FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S LEAD
MDR report key: 6150032
·
Received December 6, 2016
Report
- Report Number
- 2017865-2016-07637
- Event Type
- Malfunction
- Date Received
- December 6, 2016
- Date of Event
- June 1, 2016
- Report Date
- October 21, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. THE DEVICE WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION. THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798036 | ISOFLEX S LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1646T/58 | 0002140150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |