FDA Adverse Event
Malfunction
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 3923186
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14500
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z1483
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
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 UPON REVIEW OF SESSION RECORDS, LOW IMPEDANCES WERE NOTED AT TWO OCCASIONS ON THE LEFT VENTRICLE LEAD. THE LEAD REMAINED IMPLANTED. THE PATIENT CONDITION WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401564 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1156T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |