BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHAPSODY

    MDR report key: 774024 · Received October 27, 2006

    Report

    Report Number
    9610579-2006-00055
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 27, 2006
    Manufacturer
    ELA MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED FOLLOW UP DATA SHOWED THAT THE DEVICE WAS INTERROGATED IN 2006, I.E. 29 MONTHS AFTER IMPLANTATION. THE BATTERY IMPEDANCE WAS LOWER THAN 1KQ, I.E. AT BEGINNING OF LIFE. IT COULD NOT BE INTERROGATED THREE MONTHS LATER. UPON RECEPTION, THE RETURNED DEVICE COULD NOT BE INTERROGATED WITH THE STANDARD PROGRAMMER; IN ADDITION, NO PACING PULSES WERE PRESENT. THE DEVICE WAS OPENED TO HAVE DIRECT ACCESS TO INTERNAL COMPONENTS. IN-DEPTH INVESTIGATION REVEALED THAT THERE WAS A SHORT CIRCUIT DUE TO METAL MIGRATION ON THE COFIRED SUBSTRATE CAUSED BY A SPECIFIC MANUFACTURING PROCESS. NO SIMILAR MANUFACTURING PROCESS IS USED IN CURRENTLY MANUFACTURED SYMPHONY/RHAPSODY PACEMAKER DEVICES. IN ADDITION, THIS DEVICE WAS LISTED IN THE SAFETY NOTICE ISSUED IN 10/05 RELATED TO METAL MIGRATION ON THE POTENTIALLY EXPOSED SYMPHONY/RHAPSODY UNITS.

    Description of Event or Problem · 1

    AFTER 32 MONTHS OF IMPLANTATION, THE DEVICE INVOLVED IN THIS MDR REPORT WAS EXPLANTED BECAUSE IT COULD NOT BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHAPSODY DXY - IMPLANTABLE CARDIAC PACEMAKER DXY ELA MEDICAL 2210 S030805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R