BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 3926226 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15521
    Event Type
    Injury
    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
    Z1482
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED UNACCEPTABLE THRESHOLDS. THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404136 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention (B)(4), (B)(4)