BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3760939 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08858
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    January 24, 2013
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. OVERSENSING WAS ALSO OBSERVED. THE RV LEAD WAS PROGRAMMED OFF DUE TO A FRACTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS OBSERVED TO HAVE BEEN FRACTURED AS A RESULT OF THE PATIENT PERFORMING AGGRESSIVE YOGA TECHNIQUES. THE RV LEAD WAS REPLACED WITH NO ADVERSE PATIENT EFFECTS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239223 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R E110| 4472| 0180