BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3213186 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09998
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 4, 2013
    Report Date
    August 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND NON-BSC LEAD WERE EXPLANTED. AN INSULATION BREACH ON THE NON-BSC LEAD WAS OBSERVED, ALONG WITH A WEAK CONNECTION WITH THE DEVICE AND LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S COMPETITOR RIGHT VENTRICULAR (RV) LEAD. THE PATIENT IS YOUNGER AND IT IS BELIEVED THAT WHILE SHE HAS GROWN THE LEAD MAY HAVE STRETCHED. THERE WAS ALSO NOTED TO BE INAPPROPRIATE SHOCKS AND LOW R-WAVES. THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE DEVICE IN THE NEXT FEW MONTHS. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312561 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| L| R E102| 7122