BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 3923210 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14515
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    February 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED IN TWO PIECES. AN INSULATION ABRASION EXPOSING THE RE CABLE WAS NOTED ON THE DISTAL SEGMENT OF THE LEAD AT 4.6 CM TO 4.9 CM FROM THE DISTAL TIP.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2014, THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE IN THE BIPOLAR CONFIGURATION. THE PATIENT WAS BROUGHT BACK TO THE CLINIC ON (B)(6) 2014, VENTRICULAR BIPOLAR CAPTURE WAS OBSERVED. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401057 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1158T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention