FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 2983752
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01350
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 7, 2013
- 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
- GA
- 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 VENTRICULAR LEAD WAS IMAGED PROPHYLACTICALLY AND THE INSULATION WAS ABRADED. NO ELECTRICAL ANOMALIES WERE NOTED. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87869 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | OJX | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |