BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053399 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03649
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DURING A DEVICE INTERROGATION THERE WAS A "CHECK RV LEAD" MESSAGE THAT DISPLAYED. IT WAS NOT KNOWN IF THIS MESSAGE WAS DUE TO AN INTRINSIC HEART RATE MEASUREMENT OR PACING IMPEDANCE MEASUREMENT. THE PATIENT PLANNED TO BE MONITORED ON A REGULAR BASIS. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)