BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 5191737 · Received October 30, 2015

    Report

    Report Number
    1000165971-2015-00660
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    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

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2015, PATIENT RECEIVED (AT LEAST) 8 SHOCKS DELIVERED BY THE ICD. DESPITE A MAGNET WAS APPLIED, SHOCKS WERE STILL DELIVERED BY THE ICD. THE ICD COULD EVENTUALLY BE INTERROGATED WITH A PROGRAMMER, AND THERAPIES WERE DEACTIVATED. NEVERTHELESS, UPON READING ICD MEMORIES, IT WAS OBSERVED THAT THERE WERE NO RECORDS OF SHOCK DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722579 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 Required Intervention