BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4140238 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16801
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 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 THIS PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER) WITH THEIR HEART RATE OCCASIONALLY DROPPING BELOW 40 BEATS PER MINUTE (BPM). THE ER WAS WONDERING IF THERE WAS POTENTIALLY SOMETHING WRONG WITH THE DEVICE THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT THE DEVICE WAS NEVER INTERROGATED. WE CANNOT RULE OUT AT THIS TIME THAT THE DEVICE POTENTIALLY MALFUNCTION WHICH MAY HAVE CAUSED THE PATIENT¿S RATE TO DROP TO A RATE OF 30 BPM. THE DEVICE CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620675 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 0185| E102