BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 3926201 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15517
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT REVIEW OF THE FLUOROSCOPY IMAGE, REVEALED A NORMAL LEAD WITH NO INSULATION ABRASIONS OBSERVED.

    Description of Event or Problem · 1

    AT THE 24TH MONTH FOLLOW-UP, AN INUSLATION ABRASION WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED AN INSULATION ABRASION. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405052 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR