BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 8320018 · Received February 8, 2019

    Report

    Report Number
    1000165971-2019-00066
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 4, 2019
    Report Date
    March 25, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT. (B)(4).

    Description of Event or Problem · 0

    REPORTEDLY, DURING THE FOLLOW-UP ON (B)(6) 2019, AN UNEXPECTED DECREASE IN THE BATTERY CURVE AND A WARNING ON THE BATTERY VOLTAGE WAS OBSERVED. PRELIMINARY ANALYSIS RESULTS REVEALED THAT THE OBSERVED DROP IN THE BATTERY CURVE WAS NORMAL AND DUE TO A BATTERY REFORMING. IN ADDITION, IT WAS NOTED THAT A RESET OCCURRED ON 5 NOVEMBER 2018, WHICH CAUSED THE DISPLAYED WARNING MESSAGE AND THE LOSS OF THE BATTERY CURVE UPDATE. THIS RESET WAS MOST PROBABLY DUE TO A SINGLE UPSET EVENT (SEU) AND NORMAL BEHAVIOR WAS RESTORED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE FOLLOW-UP ON 4 JANUARY 2019, AN UNEXPECTED DECREASE IN THE BATTERY CURVE AND A WARNING ON THE BATTERY VOLTAGE WAS OBSERVED. PRELIMINARY ANALYSIS RESULTS REVEALED THAT THE OBSERVED DROP IN THE BATTERY CURVE WAS NORMAL AND DUE TO A BATTERY REFORMING. IN ADDITION, IT WAS NOTED THAT A RESET OCCURRED ON (B)(6) 2018, WHICH CAUSED THE DISPLAYED WARNING MESSAGE AND THE LOSS OF THE BATTERY CURVE UPDATE. THIS RESET WAS MOST PROBABLY DUE TO A SINGLE UPSET EVENT (SEU) AND NORMAL BEHAVIOR WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116766 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2446

    Patients

    Seq Age Sex Outcome Treatment
    1