BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3936004 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13811
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    December 7, 2013
    Report Date
    June 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND LEAD EXHIBITED OVERSENSING WHICH LEAD TO GREATER THAN 7 SECONDS OF NOISE AND PACING INHIBITION OF GREATER THAN 2 SECONDS. THE NOISE WAS FOUND ON BOTH THE SHOCKING AND RATE/SENSING PORTION OF THE RIGHT VENTRICULAR (RV) LEAD AND IT BEGAN SHORTLY AFTER IMPLANT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THERE MIGHT BE A LEAD ISSUE GOING ON. ATTEMPTS TO GAIN ADDITIONAL INFORMATION REGARDING OUTCOME OF THIS EVENT HAVE BEEN UNSUCCESSFUL AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414137 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR H210| 0184| N161| 4542| 4136| 4554