BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2170280 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10302
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE. THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD VENTRICULAR FIBRILLATION (VF). THE DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) WHICH DID NOT CONVERT THE VF. AFTER ATP WAS DELIVERED, THE PATIENT'S R WAVE AMPLITUDE BECAME SMALLER, AT WHICH TIME THE DEVICE BEGAN TO UNDERSENSE THE VF. EVENTUALLY THE R WAVES BECAME LARGER AND THE DEVICE DELIVERED A 14 JOULE SHOCK WHICH CONVERTED THE PATIENT TO NORMAL SINUS RHYTHM. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening E102| 0185| T135