BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHAPSODY +

    MDR report key: 1960333 · Received December 15, 2010

    Report

    Report Number
    9610579-2010-00637
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS FOUND IN STANDBY MODE. REPORTEDLY, THIS WAS AN EARLY F/U AFTER RADIATION TREATMENT FOR CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHAPSODY + NVZ SORIN CRM RHAPSODY + DR 2530 M071026

    Patients

    Seq Age Sex Outcome Treatment
    1