BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 3252718 · Received July 29, 2013

    Report

    Report Number
    2017865-2013-05038
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    September 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE VENTRICULAR TIP SETSCREW WAS STRIPPED. BOTH SEPTA WERE DAMAGED AND SEPTUM MATERIAL WAS NOTED INSIDE THE VENTRICULAR TIP SETSCREW INSET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR THE RIGHT VENTRICULAR LEAD, THE PULSE GENERATOR'S SETSCREW WAS STRIPPED. THE LEAD COULD NOT BE DISCONNECTED AND THE LEAD AND PULSE GENERATOR WERE EXPLANTED AND REPLACED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352709 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention