BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3043145 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03653
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED ALL SEAL PLUGS WERE INTACT AND ALL SETSCREWS MOVED FREELY. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. VISUAL INSPECTION OF THE HEADER PORT NOTED THE LOCATION OF THE LEAD SEAL RING MARKS INDICATED THE LEAD HAD NOT BEEN FULLY INSERTED WITHIN THE PORT. THIS WAS LIKELY THE CAUSE OF THE OUT OF RANGE PACING IMPEDANCES AND NOISE ON THE RV LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. ADDITIONALLY, NOISE WAS OBSERVED ON THE RATE/SENSE CHANNEL. THE HIGH PACING IMPEDANCE MEASUREMENTS AND NOISE COULD NOT BE RECREATED IN CLINIC. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147713 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R E110| E161| H177| 0175| 5076| 0184