BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHAPSODY+

    MDR report key: 2992348 · Received March 1, 2013

    Report

    Report Number
    9610579-2013-00017
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY, THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS INTERROGATED ON (B)(6) 2013 AND A RAPID BATTERY DEPLETION WAS OBSERVED. IN ONE YEAR, THE INTERNAL BATTERY IMPEDANCE INCREASED FROM 0.96 KOHM TO 10.8 KOHM. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS, ANOTHER DEVICE WAS IMPLANTED. UPON INTERROGATION OF THE DEVICE FOUR DAYS AFTER EXPLANTATION, THE INTERNAL BATTERY IMPEDANCE WAS 27.39 KOHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89290 RHAPSODY+ NVZ SORIN CRM RHAPSODY + DR 2530 S040830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention