BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2173817 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10968
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 2011
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 DURING A STENT PROCEDURE, A VENTRICULAR FIBRILLATION (VF) EVENT OCCURRED. THIS DEVICE SYSTEM UNDERSENSE THE ARRHYTHMIA. ULTIMATELY, ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED THREE TIMES, FOLLOWED BY A 31 JOULE SHOCK THAT CONVERTED THE ARRHYTHMIA. THE PATIENT IMPLANTED WITH THIS DEVICE WAS BROUGHT IN FOR A NON-INVASIVE STIMULATION PROCEDURE (NIPS) AND WITH AN AUTOMATIC GAIN CONTROL (AGC) OF 0.25 MILLIVOLTS, APPROXIMATELY FIVE SECONDS OF UNDERSENSING WAS OBSERVED. THE DEVICE DID DETECT AND SHOCK FOLLOWING THE PAUSE. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR E110| 0184| 4469| T135