BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURITY DR

    MDR report key: 3920593 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14200
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    March 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT A TEST LEAD COULD NOT BE INSERTED INTO THE VENTRICULAR CONNECTOR WITHIN NORMAL PRODUCT SPECIFICATIONS. THE CAUSE OF THE ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PULSE GENERATOR HAD DIFFICULTY ACCEPTING A RIGHT VENTRICULAR LEAD. THE DEVICE WAS NOT IMPLANTED AND A NEW ONE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396230 ENDURITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1