BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 4062534 · Received September 5, 2014

    Report

    Report Number
    1000165971-2014-00511
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED

    Description of Event or Problem · 1

    SEVERAL EPISODES WITH VENTRICULAR OVERSENSING ARE RECORDED IN DEVICE MEMORIES. THE CARDIOLOGIST HAD SCHEDULED THE REPLACEMENT OF THE LEAD AND THE DEVICE BUT THE PATIENT PASSED AWAY BEFORE OF EXTRA CARDIAC CAUSES.

    Description of Event or Problem · 1

    SEVERAL EPISODES WITH VENTRICULAR OVERSENSING ARE RECORDED IN DEVICE MEMORIES. THE CARDIOLOGIST HAD SCHEDULED THE REPLACEMENT OF THE LEAD AND THE DEVICE BUT THE PATIENT PASSED AWAY BEFORE OF EXTRA CARDIAC CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544819 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death