BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF VR

    MDR report key: 2902657 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00255
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 15, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A SENSING ANOMALY WAS NOT REPRODUCED IN THE LABORATORY. THE DEVICE IMAGE WAS CORRUPTED AND INFORMATION COULD NOT BE EXTRACTED. NO ELECTROGRAMS WERE AVAILABLE ON PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED USING AUTOMATED TEST EQUIPMENT AND PASSED ALL TESTS. THE CAUSE OF THE FIELD EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT REPORTED TO THE ER AFTER FAINTING AND RECEIVING THERAPY. INTERROGATION SHOWED THE ICD SUCCESSFULLY DETECTED AND TREATED VF BUT A FEW UNDERSENSED EVENTS WERE OBSERVED. RESOLVED BY REPROGRAMMING VENTRICULAR SENSITIVITY.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8698 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR