BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3813170 · Received May 15, 2014

    Report

    Report Number
    1000165971-2014-00274
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2014, A REMOTE FOLLOW-UP ALERT REPORT WAS TRIGGERED BECAUSE OF SHOCK DELIVERY. ON (B)(6) 2014, A FACE TO FACE FOLLOW-UP WAS PERFORMED: THE PHYSICIAN REALIZED THAT THE ALERT REPORT WAS ACTUALLY REFERRING TO THE SHOCK DELIVERED BY INDUCTION DURING THE IMPLANTATION ON (B)(6) 2014.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2014, THE 7TH, A REMOTE FOLLOW-UP ALERT REPORT WAS TRIGGERED BECAUSE OF SHOCK DELIVERY. ON (B)(6) 2014, A FACE TO FACE FOLLOW-UP WAS PERFORMED: THE PHYSICIAN REALIZED THAT THE ALERT REPORT WAS ACTUALLY REFERRING TO THE SHOCK DELIVERED BY INDUCTION DURING THE IMPLANTATION ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290921 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2770

    Patients

    Seq Age Sex Outcome Treatment
    1