FDA Adverse Event
Malfunction
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 4231359
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18139
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- September 10, 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
- CA, 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 DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED. THE LEAD WAS CAPPED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714544 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1156T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | (B)(4) |