BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212979 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10292
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 23, 2013
    Report Date
    April 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM GENERATED A RED ALERT FOR A SINGLE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS REPORTED AND NO SYSTEM CHANGES TO DATE. THE ASSOCIATED RIGHT VENTRICULAR LEAD IS A NON BOSTON SCIENTIFIC PRODUCT AND THE PHYSICIAN HAS ELECTED TO MONITOR ONLY AT THIS TIME.

    Description of Event or Problem · 1

    SUBSEQUENTLY, ANOTHER HIGH OUT OF RANGE SHOCK IMPEDANCE VALUES HAS BEEN TRIGGERED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE PHYSICIAN HAS INDICATED THE PATIENT WOULD CONTINUE TO BE MONITORED WITH NO PLANS FOR SURGICAL INTERVENTION. NO ADVERSE PATIENT EFFECTS OR ANY OTHER CLINICAL OBSERVATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312418 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR E102| MISMATCH