BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 5771669 · Received July 6, 2016

    Report

    Report Number
    1000165971-2016-00392
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 10, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    UPON INTERROGATION DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016, A WARNING MESSAGE WAS DISPLAYED INDICATING THAT ONE DEVICE RESET OCCURRED. THE DEVICE APPEARED TO BE OPERATING NORMALLY. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED BEHAVIOR. THE RECORDED RESET OCCURRED ON (B)(6) 2016 AND WAS MOST PROBABLY DUE TO A SINGLE UPSET EVENT (SEU). NORMAL DEVICE OPERATION AFTER THE RESET WAS CONFIRMED.

    Description of Event or Problem · 1

    UPON INTERROGATION DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2016, A WARNING MESSAGE WAS DISPLAYED INDICATING THAT ONE DEVICE RESET OCCURRED. THE DEVICE APPEARED TO BE OPERATING NORMALLY. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED BEHAVIOR. THE RECORDED RESET OCCURRED ON (B)(6) 2016 AND WAS MOST PROBABLY DUE TO A SINGLE UPSET EVENT (SEU). NORMAL DEVICE OPERATION AFTER THE RESET WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427999 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2501

    Patients

    Seq Age Sex Outcome Treatment
    1