BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3062907 · Received April 12, 2013

    Report

    Report Number
    1000165971-2013-00206
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 29, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ELECTRICAL AND CONNECTION ISSUES WERE NOTED THE SUBJECT PACEMAKER. REPORTEDLY, DURING A FOLLOW UP HIGH IMPEDANCES WERE IDENTIFIED SINCE ONE MONTH AFTER IMPLANTATION. A PACEMAKER REVISION WAS PERFORMED. DURING THE RE-INTERVENTION THE LEAD CAME OUT OF THE PORT WITHOUT UNSCREWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159092 REPLY NVZ NVZ SORIN C.R.M., S.R.L. REPLY SR 2580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention