BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3760997 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08856
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    October 7, 2012
    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 Location
    CT
    Reporter Occupation
    PHYSICIAN

    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 EXHIBITED HIGH OUT OF RANGE PACE LEAD IMPEDANCES GREATER THAN 2,000 OHMS. OTHER LEAD MEASUREMENTS WERE STABLE AND THERE IS NO NOISE ON THE RATE/SENSE CHANNEL. FURTHER TROUBLESHOOTING WAS TO BE PERFORMED. THE PATIENT'S LEAD DATA WAS EVALUATED, THE PACING IMPEDANCES HAVE GRADUALLY INCREASED OVERTIME AND THE THRESHOLDS AND SENSING ARE STABLE. THERE IS NO EVIDENCE OF NOISE ON THE RV CHANNEL. ADDITIONAL INFORMATION INDICATES THAT THIS LEAD CONTINUED TO EXHIBITED OUT OF RANGE PACING IMPEDANCES. NOISE WAS REPORTED TO BE OBSERVED ON THE SHOCK ELECTROGRAM AND SOME ON THE RATE/SENSE CHANNEL; HOWEVER, IT IS NOT BEING SENSED BY THE DEVICE. THERE HAS ALSO BEEN AN INCREASE IN PACING THRESHOLDS. ADDITIONAL INFORMATION INDICATES THAT A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH PACING AND SHOCK IMPEDANCES ALONG WITH NOISE ON THE SHOCK CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241209 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 1861| T165| 4053| 0147| E110