BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3936133 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13815
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 24, 2014
    Report Date
    March 24, 2016
    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

    (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.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A REVIEW OF THE TREND SHOWED A SLOW AND GRADUAL RISE IN THE SHOCKING IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN PLANS TO BRING THE PATIENT INTO THE CLINIC FOR EVALUATION AT AN UNKNOWN FUTURE DATE AND CONTINUE TO MONITOR THE IMPEDANCE MEASUREMENTS IN THE MEANTIME. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH THRESHOLD MEASUREMENTS WERE ALSO OBSERVED AND A LEAD FRACTURE WAS SUSPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A LEAD FRACTURE WAS NOT VISIBLE THROUGH X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412102 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R T125| E110| 4473