BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905396 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10673
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 3, 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
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    00802526444289 UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THAT THERE WAS INDUCED PHYSICAL DAMAGE TO THE DEVICE CASE IN THE FORM OF TOOL MARK SCRATCHES AND SEVERAL SMALL DENTS THAT OCCURRED AT THE TIME OF EXPLANT. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED DECREASED PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. ADDITIONALLY, THRESHOLD MEASUREMENTS HAD INCREASED TO 2.3V @ 0.5MS. AN INSULATION CONCERN WAS EXPRESSED. A REVISION PROCEDURE WAS PERFORMED. THE CHRONIC DEVICE WAS NOTED TO BE IMPLANTED EXTREMELY DEEPLY SUBCUTANEOUSLY AND THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DEVICE, RESULTING IN DENTING THE DEVICE. ULTIMATELY, THE DEVICE WAS EXPLANTED AND REPLACED. THE RA LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383038 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R E143| 4087| MISMATCH| E110| 0158| A135