BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211074 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09957
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE THE DEVICE REMAINS IMPLANTED AND THERE HAS NOT BEEN ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. 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 IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED THEY HAD A SYNCOPAL EPISODE IN WHICH THEY HAD PASSED OUT FOR 45 SECONDS. WHEN THE PATIENT CAME TO THEY WERE TOLD IT WAS THOUGHT THEY HAD RECEIVED A SHOCK. PATIENT HAD INQUIRED IF THERE HAD BEEN A SHOCK DELIVERED AND WAS REFERRED TO SPEAK TO THEIR PHYSICIAN TO REVIEW REMOTE MONITORING INFORMATION AND DISCUSS ANY FURTHER HEALTH QUESTIONS. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT REQUESTING THE CAUSE OF THE SYNCOPAL EPISODE WAS BUT WAS INCONCLUSIVE. THERE WERE NO ADDITIONAL PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309738 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening 4136| 0185| E110