BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904167 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09261
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 CALLED PATIENT SERVICES STATING THAT THEY HAD BEEN WALKING, GOT WEAK AND PASSED OUT, AFTER WHICH THE DEVICE SHOCKED THEM, THEN THE PATIENT REGAINED CONSCIOUSNESS AND FELT BETTER. THE PATIENT THEN WAS SEEN BY HIS PHYSICIAN AND THEY TOLD HIM HIS MEDICATIONS WERE LOW AND THAT HIS DEVICE SHOCKED HIM AND HIS HEART DIDN'T RESTART SO IT SHOCKED HIM AGAIN AND IT RESTARTED THE HEART. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL AT THIS TIME. SHOULD ANY NEW INFORMATION BECOME AVAILABLE THIS RECORD WILL BE UPDATED. THE DEVICE SYSTEM REMAINS IMPLANTED AT THIS TIME. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382268 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 0184| 1688TC| E110