FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 2905263
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00474
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- November 27, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z1482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO A FOLLOW UP AND WAS DIAGNOSTICALLY IMAGED PROPHYLACTICALLY; THE LEAD INSULATION WAS ABRADED. THE LEAD'S ELECTRICAL FUNCTION WAS TESTED AND NO ANOMALIES WERE OBSERVED. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11243 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | OJX | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |