BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4932556 · Received July 22, 2015

    Report

    Report Number
    2124215-2015-09545
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THOUGHT THAT THE DEVICE WAS NOT WORKING AND FELT A THUMP DAILY. THE PATIENT ALSO REPORTED THAT THE DEVICE WAS PUT IN WRONG AND HAD TO BE REDONE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED TO PATIENT TO THEIR PHYSICIAN TO ADDRESS THEIR SYMPTOMS AND CONCERNS. THERE WAS NO FURTHER INFORMATION OBTAINED FROM THE FIELD THAT COULD FURTHER VERIFY THIS EVENT. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476071 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 4470| E110| T125| 0158