FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1626856
·
Received March 10, 2010
Report
- Report Number
- 2017865-2010-00826
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- December 16, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMAP030054
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NOTIFIER WENT OFF TO ALERT OF A LEAD IMPEDANCE LESS THAN 200 OMHS. THE PATIENT PRESENTED FOR TESTING, BUT THE LOW LEAD IMPEDANCE COULD NOT BE REPRODUCED. ALL OTHER MEASUREMENTS AND A REVIEW OF TREND READINGS WERE IN RANGE AND STABLE. THE LEAD WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |