BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212441 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08562
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    February 11, 2013
    Report Date
    May 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A LOW, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHICH HAD BEEN DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT HAD BEEN IN THE HOSPITAL HAVING A DIAGNOSTIC TEST AT THE TIME THAT THE LOW MEASUREMENT WAS RECORDED. ALL SUBSEQUENT MEASUREMENTS HAVE BEEN NORMAL. THE PATIENT WILL CONTINUE TO BE MONITORED WITH ROUTINE FOLLOW UP. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314159 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR E102| 0157