FDA Adverse Event
Injury
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 2240381
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05438
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- June 30, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE LEAD COIL WAS DAMAGED AT 84.5 CM FROM THE CONNECTOR PIN. THE INSULATION WAS DAMAGED IN THE SAME AREA BY THE GUIDEWIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE LEAD DISLODGED. AFTER MULTIPLE ATTEMPTS TO REPOSITION THE LEAD AND HAVING THE GUIDEWIRE GET STUCK, THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1258T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |