FDA Adverse Event
Malfunction
Summary report: N
QUICKFLEX XL LV LEAD
MDR report key: 3923209
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14514
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- March 26, 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
- CO, US
- 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A ROUTINE DEVICE CHECK. UPON INTERROGATION, THE LEFT VENTRICULAR LEAD EXHIBITED AN INSTANCE OF LOW IMPEDANCE. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401969 | QUICKFLEX XL LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1158T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |