BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2910563 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15471
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE ELECTROGRAM (EGM) STRIPS WERE UNABLE TO BE OBTAINED. THE SALES REPRESENTATIVE HAS NOT BEEN CONTACTED FOR ANY ADDITIONAL CONCERN REGARDING DEVICE INVOLVEMENT OR AN UPDATE ON THE PATIENT'S STATUS. HOWEVER, IT WAS COMMUNICATED THAT THE PATIENT WAS HYPERCALCEMIA. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE UNDERSENSING VENTRICULAR FIBRILLATION (VF) WHICH RESULTED IN DELAYED THERAPY FOR THE PATIENT. IT WAS REPORTED THE PATIENT ARRIVED AT THE HOSPITAL NOT FEELING WELL, EXPERIENCED CARDIAC ARREST AND WAS RESUSCITATED. A REVIEW OF THE EPISODE INDICATED VERY FINE VF. THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SEVERAL SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18648 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R E102| 0184