BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4132217 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15582
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A RECENT IN OFFICE DEVICE CHECK OF SHOCKING IMPEDANCES, A VALUE OF ZERO OHMS WAS NOTED. THE OTHER DAILY MEASUREMENTS WERE WITHIN RANGE AND THE PATIENT HAD GONE HOME WHEN THE HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TS EXPLAINED THAT TYPICALLY A VALUE OF ZERO MEANS ELECTROMAGNETIC INTERFERENCE (EMI) AND IT COULD BE A ONE TIME MEASUREMENT. THE HCP STATED THE PATIENT WILL BE BACK IN AGAIN IN ONE MONTH AND THEY WILL CHECK THE IMPEDANCES AGAIN AT THAT TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612085 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR 0185| E110| 4087