BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX SR

    MDR report key: 3920468 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14066
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED A DIAGNOSTICS ANOMALY. ON (B)(6) 2014 THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396820 IDENTITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention