FDA Adverse Event
Injury
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 3925915
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15305
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- April 18, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 X-RAY CONFIRMED THE VENTRICULAR LEAD HAD DISLODGED. UPON SURGERY, SEVERAL ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403097 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1258T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |