FDA Adverse Event
Summary report: N
QUICKFLEX XL LV LEAD
MDR report key: 3852164
·
Received June 5, 2014
Report
- Report Number
- 2017865-2014-01499
- Date Received
- June 5, 2014
- Date of Event
- July 24, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- 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.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND INTERMITTENT LOSS OF CAPTURE. THE PATIENT COMPLAINED OF FEELING SYMPTOMATIC DURING POCKET MANIPULATION. THE LEAD WAS FRACTURED, CAPPED AND REPLACED.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE LEAD WAS EXPLANTED AND RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329465 | QUICKFLEX XL LV LEAD | PERMANENT PACEMAKER ELECTRODE | NIK | ST. JUDE MEDICAL, INC. CRMD | 1158T/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |