BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910870 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15895
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE LOCAL SALES REPRESENTATIVE, HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD THAT THE LEAD WAS BROKEN AND WAS SCHEDULED TO BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16822 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR T165| 4086| 0184