FDA Adverse Event
Injury
Summary report: N
QUICKFLEX MICRO LV LEAD
MDR report key: 4191792
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05441
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- February 9, 2011
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: FINAL ANALYSIS FOUND DAMAGED INSULATION AT 19.2 CM FROM THE TIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD DAMAGED INSULATION. THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29569 | QUICKFLEX MICRO LV LEAD | NIK | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1258T/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |