FDA Adverse Event
Malfunction
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 1896241
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04830
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 11, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 PATIENT WAS ADMITTED ON (B)(6) 2010 DUE TO CONGESTIVE HEART FAILURE. INTERROGATION REVEALED THAT THE LEFT VENTRICULAR LEAD EXHIBITED NO CAPTURE. THE LEAD WAS THEN TURNED OFF. ON (B)(6) 2010 FLUOROSCOPY SHOWED THAT THE LEAD HAD MIGRATED TO THE RIGHT ATIAL CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1156T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |