FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 3925839
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15666
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- May 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- Z1482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 THE DURING ROUTINE DEVICE CHANGE OUT AT PRE-OP INTERROGATION, THE LEFT VENTRICLE LEAD EXHIBITED LOSS OF CAPTURE. X-RAY CONFIRMED THE LEAD HAD DISLODGED. THE LEAD WAS NOT REPOSITIONED AND THE NEW DEVICE WAS PROGRAMMED TO RIGHT VENTRICLE PACING ONLY. THE CONDITION OF THE PATIENT WAS GOOD BEFORE AND AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404155 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |