BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM RF

    MDR report key: 6490078 · Received April 13, 2017

    Report

    Report Number
    1000165971-2017-00316
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 17, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS SHOWED THAT THE MOST PROBABLE CAUSE OF RESET IS AN EXTERNAL PERTURBATION DURING IMPLANT (COULD BE ESD OR ELECTROMAGNETIC INTERFERENCES OR OTHER) . NOTE THAT THE REPORTED WARNING MESSAGE[44] CANNOT BE RESET.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2017. WHEN THE DEVICE WAS INTERROGATED AT HEMATOMA EVACUATION, THE FOLLOWING WARNING MESSAGES WERE DISPLAYED TO THE USER : [27] THE DEVICE WAS REINITIALIZED 1TIME SINCE THE BEGINNING OF LIFE. [59] RESET OCCURRED ON (B)(6) 2017. [44] TECHNICAL ISSUE. DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE. CONTACT SORIN. CLARIFICATION REQUIRED ON CAUSES OF THESE WARNING MESSAGES.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2017. WHEN THE DEVICE WAS INTERROGATED AT HEMATOMA EVACUATION, THE FOLLOWING WARNING MESSAGES WERE DISPLAYED TO THE USER : THE DEVICE WAS REINITIALIZED 1TIME SINCE THE BEGINNING OF LIFE RESET OCCURRED ON (B)(6) 2017 TECHNICAL ISSUE. DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE. CONTACT SORIN CLARIFICATION REQUIRED ON CAUSES OF THESE WARNING MESSAGES.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2017. WHEN THE DEVICE WAS INTERROGATED AT HEMATOMA EVACUATION, THE FOLLOWING WARNING MESSAGES WERE DISPLAYED TO THE USER : [27]THE DEVICE WAS REINITIALIZED 1 TIME SINCE THE BEGINNING OF LIFE. [59] RESET OCCURRED ON (B)(6) 2017. [44] TECHNICAL ISSUE. DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE. CONTACT SORIN. CLARIFICATION REQUIRED ON CAUSES OF THESE WARNING MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271621 PARADYM RF DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 S0211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention