BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3921838 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-10876
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    December 1, 2012
    Report Date
    April 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE LATEST SEND FROM THE REMOTE MONITORING SYSTEM AND DISCUSSED THAT SIGNALS ON THE ATRIAL CHANNEL MAY INDICATE POTENTIAL NOISE. FURTHERMORE, THERE APPEARED TO BE ATRIAL UNDERSENSING ON THE PRESENTING ELECTROGRAM (EGM). A REVIEW ON THE ARRHYTHMIA LOGBOOK DETERMINED THAT THERE WAS A HISTORY OF OVERSENSED NOISE ON THE ATRIAL CHANNEL; HENCE, DEVICE PROGRAMMING WAS DONE. SUBSEQUENT INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE OBSERVATION WAS NOT CONCLUSIVELY DETERMINED AND ADDITIONAL PROGRAMMING WILL BE PERFORMED ON THE PATIENT¿S NEXT CLINIC VISIT. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399238 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR E110| 4087| 0158| A135