BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952810 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24542
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS REMAIN IMPLANTED. 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 THE PATIENT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD EXPERIENCED A SYNCOPAL EPISODE AND WAS HOSPITALIZED. NOISE RESULTING IN OVERSENSING WITH A PACED RATE IN THE 20'S WAS RECORDED THREE MONTHS PRIOR. THE PATIENT IS PACEMAKER DEPENDENT. TECHNICAL SERVICE WAS CONTACTED AND DISCUSSED PROGRAMMING OPTIONS SINCE THE PATIENT WAS NOT A GOOD SURGICAL CANDIDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization 4015| 1297| 1283| 0158| 4456| N119| 4543