BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904440 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09474
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 31, 2014
    Report Date
    February 2, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    NEW INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS EXPLANTED FOR AN UNRELATED REASON. THE DEVICE WAS GIVEN TO THE PATIENT FOLLOWING EXPLANT AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPERIENCED MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) AT 220 BEATS PER MINUTE. THE DEVICE SENSED AND DELIVERED SHOCK THERAPY. THE SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS AND WAS UNABLE TO SUCCESSFULLY TERMINATE THE VT. SUBSEQUENTLY, THE DEVICE DELIVERED 8 INAPPROPRIATE SHOCKS AND THE PATIENT TERMINATED THE RHYTHM ON THEIR OWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE RV LEAD WAS SURGICALLY CAPPED AND ABANDONED. A NEW RV LEAD IMPLANTED AND CONVERSION TESTING WAS SUCCESSFUL. THE ICD REMAINS IN-SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384496 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 259 MO Hospitalization| L| R F110| 0181| 4096