BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITY ADX SR

    MDR report key: 2240113 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05871
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 7, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S POCKET WAS OPENED AND CLOSED FOUR TIMES. THE PULSE GENERATOR EXHIBITED LOSS OF CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5156 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention