FDA Adverse Event
Malfunction
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 4121662
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-07633
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 5, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY MANEUVERING THE LEAD OVER THE GUIDEWIRE. THE LEAD WAS NOT IMPLANTED. THE PATIENT HAD A HAEMOTHORAX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32775 | QUICKFLEX MICRO LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST. JUDE MEDICAL, CRMD | 1258T/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |