BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHAPSODY +

    MDR report key: 2103648 · Received May 20, 2011

    Report

    Report Number
    9610579-2011-00052
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A HEART OPERATION, THE PT UNDERGONE EXTERNAL DEFIBRILLATION. UPON INTERROGATION FOLLOWING THE INTERVENTION ((B)(6), 2011), THE PHYSICIAN DID NOT SUCCEED IN INTERROGATING THE DEVICE AND THE FOLLOWING MESSAGE WAS DISPLAYED: "UNDER CLINICAL EVAL, NOT MANUFACTURED FROM SORIN,...". IN ADDITION, PACING PULSES WERE VISIBLE ON AN ECG BUT NOT EFFECTIVE. THE DEVICE DID NOT REACT TO THE MAGNET APPLICATION. A SECOND INTERROGATION USING ANOTHER PROGRAMMER ALSO FAILED ON (B)(6), 2011. DEVICE EXPLANTATION WAS RECOMMENDED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHAPSODY + NVZ SORIN CRM RHAPSODY + DR 2530 S080702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention