FDA Adverse Event
Malfunction
Summary report: N
QUICK FLEX LV LEAD
MDR report key: 4140129
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05960
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- June 22, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFO WAS PROVIDED BY MFR, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LOW IMPEDANCE READING ON THE LEFT VENTRICULAR LEAD. THE DEVICE REMAINED IMPLANTED WHILE THE NURSE ELECTED TO BRING THE PT IN FOR FURTHER TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34323 | QUICK FLEX LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST. JUDE MEDICAL, CRMD | 1156T/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |