BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY II SR+

    MDR report key: 2905258 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00788
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 5, 2012
    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. EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO EXHIBIT PREMATURE BATTERY DEPLETION WHICH WAS CAUSED BY AN INTERMITTENT HIGH CURRENT DRAIN. THE IC MANUFACTURER WAS UNABLE TO REPRODUCE THE INTERMITTENT HIGH CURRENT DRAIN CONDITION AT IC LEVEL. THE ROOT CAUSE FOR HIGH CURRENT DRAIN COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE PULSE GENERATOR EXHIBITED PREMATURE END OF LIFE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10870 MICRONY II SR+ IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2525T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention