BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHAPSODY

    MDR report key: 3642644 · Received December 20, 2013

    Report

    Report Number
    9610579-2013-00111
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Report Date
    December 10, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO SYMPHONY/RHAPSODY PACEMAKER MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN WAS SURPRISED ABOUT THE DISPLAYED RESIDUAL LONGEVITY ESTIMATION OF THE SUBJECT PACEMAKER. THE PHYSICIAN WOULD LIKE TO KNOW IF THIS ESTIMATION IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669584 RHAPSODY NVZ SORIN CRM RHAPSODY S 2130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1