BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 5738288 · Received June 21, 2016

    Report

    Report Number
    1000165971-2016-00364
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 25, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    REPORTEDLY, THE BATTERY CURVE WAS FOUND WITH ABNORMAL SHAPE. IN ADDITION, A WARNING MESSAGE WAS DISPLAYED STATING THAT THE DEVICE REACHED ITS RRT (RECOMMENDED REPLACEMENT TIME). NOTE THAT THE PATIENT UNDERWENT RADIOTHERAPY. PRELIMINARY ANALYSIS REVEALED THAT THE ABNORMAL DISPLAY OF THE BATTERY CURVE IS DUE TO A CORRUPTION IN DEVICE MEMORY DATA, RESULTING IN ONE INCORRECT DATE STORED IN THE BATTERY CURVE. IT COULD BE DUE TO A SEU, POTENTIALLY RELATED TO THE RADIATION THERAPY SESSIONS THAT THE PATIENT REPORTEDLY UNDERWENT. DEVICE REPLACEMENT WAS RECOMMENDED BECAUSE ANALYSIS CONFIRMED THAT THE DEVICE REACHED ITS R.R.T.

    Description of Event or Problem · 1

    REPORTEDLY, THE BATTERY CURVE WAS FOUND WITH ABNORMAL SHAPE. IN ADDITION, A WARNING MESSAGE WAS DISPLAYED STATING THAT THE DEVICE REACHED ITS RRT (RECOMMENDED REPLACEMENT TIME). NOTE THAT THE PATIENT UNDERWENT RADIOTHERAPY. PRELIMINARY ANALYSIS REVEALED THAT THE ABNORMAL DISPLAY OF THE BATTERY CURVE IS DUE TO A CORRUPTION IN DEVICE MEMORY DATA, RESULTING IN ONE INCORRECT DATE STORED IN THE BATTERY CURVE. IT COULD BE DUE TO A SEU, POTENTIALLY RELATED TO THE RADIATION THERAPY SESSIONS THAT THE PATIENT REPORTEDLY UNDERWENT. DEVICE REPLACEMENT WAS RECOMMENDED BECAUSE ANALYSIS CONFIRMED THAT THE DEVICE REACHED ITS R.R.T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393231 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention