BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN 100

    MDR report key: 1781511 · Received July 26, 2010

    Report

    Report Number
    MW5016847
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A VITALITY DS ICD SINCE (B)(6) 2007 THAT EXHIBITED SIGNS OF ERI IN (B)(6) 2010. THE PT WAS ADMITTED FOR ICD REPLACEMENT AND RECEIVED A BOSTON SCIENTIFIC TELIGEN 100 (E110/(B)(4)) ON (B)(6) 2010. AT IMPLANT, THE R-WAVE SENSING WAS 2.5 MV, UNCHANGED FROM SEVERAL YEARS BACK. OF NOTICE IS THAT WITH THIS 2.5MV R-WAVE, THERE HAD BEEN YEARLY DFT TESTING WITH NO PROBLEMS IN DETECTION. THE NEW DEVICE WAS TESTED BY GIVING A T-SYNCHRONOUS SHOCK AND INDUCING VF. THERE WAS NO BLANKING PERIOD AFTER THE T-WAVE SHOCK AND THE DEVICE STARTED A-V PACING, STARTING WITH THE EXPECTED V-A INTERVAL, FOLLOWED BY 10 PACED BEATS. THEN VF WAS SENSED AND TREATED WITH A SHOCK BY THE DEVICE. A SECOND INDUCTION WAS ATTEMPTED WITH A T-WAVE SYNCHRONOUS SHOCK THAT INDUCED VF. THE DEVICE STARTED PACING IMMEDIATELY AFTER THE SHOCK AND VF WAS NOT DETECTED. AN EXTERNAL SHOCK HAD TO BE GIVEN. WE THINK THE PROBLEM IS THE ABSENCE OF A BLANKING PERIOD AFTER THE T-WAVE SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN 100 ICD LWS BOSTON SCIENTIFIC E110 146273

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization