FDA Adverse Event
Injury
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 1896620
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04859
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 14, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 LEAD FRACTURED AT THE COSTOCLAVICLE CLIP LEVEL AND THE LEAD FAILED TO STIMULATE. ATTEMPTS TO REMOVE THE LEAD WERE UNSUCCESSFUL. 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/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |