BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053626 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05349
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    June 20, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS SYSTEM IS CONTINUING TO EXHIBIT SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A REPEAT ECHOCARDIOGRAM WILL BE PERFORMED AS THEY BELIEVE THE PATIENT'S EJECTION FRACTION (EF) MAY HAVE IMPROVED. 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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS SYSTEM IS CONTINUING TO EXHIBIT SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. EFFORTS TO OBTAIN ADDITIONAL DETAILS WERE UNSUCCESSFUL. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO THE OFFICE AND UPON EVALUATION, THE SHOCKING LEAD IMPEDANCE WAS CONSISTENT AT 114 OHMS. WHEN THE PATIENT MOVED HISS LEFT ARM ACROSS HIS CHEST THE IMPEDANCE INCREASED TO 124 OHMS. SINCE ALL OTHER LEAD MEASUREMENTS WERE STABLE AND WITHIN RANGE, THE PHYSICIAN OPTED TO CONTINUE TO MONITOR VIA THE REMOTE HOME MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT WAS ISSUED BY THE REMOTE HOME MONITORING SYSTEM FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154446 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0184| T165| E110| 4472