BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210014 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07203
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 21, 2013
    Report Date
    January 19, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO REVISION HAS BEEN SCHEDULED AND THE PATIENT WILL CONTINUE TO BE MONITORED. 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

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED A RED ALERT DUE TO HIGH PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. ATTEMPTS WERE MADE TO OBTAINED THE MODEL AND SERIAL NUMBER OF THE RIGHT VENTRICULAR (RV) LEAD, HOWEVER WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT'S PHYSICIAN IS AWARE OF THIS SITUATION. THE DEVICE AND LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE MODEL AND SERIAL NUMBER OF THE RV LEAD. ALSO, ANOTHER SYSTEM ALERT WAS RECEIVED ON HIGH OUT-OF-RANGE PACING IMPEDANCE. A HIGH THRESHOLD WAS REPORTED; HOWEVER, THE SHOCK LEAD IMPEDANCE AND R-WAVE WAS STABLE AND WITHIN NORMAL RANGE WITH NO NOISE WERE OBSERVED. FURTHERMORE, IT WAS CONFIRMED THAT THE PATIENT WAS NOT PACER DEPENDENT AND NO REVISION WAS DONE AT THIS TIME. THE PATIENT WILL BE MONITORED CONTINUALLY WITH THE REMOTE MONITORING SYSTEM.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE HIGH THRESHOLD AND PACING IMPEDANCE MEASUREMENTS WERE ONGOING. ADDITIONALLY, PREMATURE BATTERY DEPLETION WAS SUSPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND INDICATED THE BATTERY APPEARED APPROPRIATE AS THE LONGEVITY HAD NOT DECREASED WITHIN THE LAST YEAR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311643 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1