BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY AFX

    MDR report key: 2014047 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01731
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 14, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC AND EXPERIENCED DIZZY SPELLS. THE HOLTER MONITOR EXHIBITED 2 TO 3 SECOND PAUSES. THE PULSE GENERATOR EXHIBITED VENTRICULAR OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY AFX IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5346 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention