BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3894720 · Received June 25, 2014

    Report

    Report Number
    1000165971-2014-00367
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A WARNING STATING "SHOCK OFF" WAS SENT BY THE HOME MONITOR ON (B)(6) 2014 ALTHOUGH THIS WARNING IS ACTUALLY DATED (B)(6) 2014 (SHOCKS WERE OFF ON THE DAY OF IMPLANT; THEY HAVE BEEN ACTIVATED AFTER THE IMPLANT). REPORTEDLY, ON (B)(6) 2014 SHOCKS WERE ON. MOREOVER, JUST AFTER THIS INTERROGATION, A FOLLOW-UP REPORT HAS BEEN GENERATED FOR NO REASON. THE CUSTOMER REQUESTED AN EXPLANATION.

    Description of Event or Problem · 1

    A WARNING STATING "SHOCK OFF" WAS SENT BY THE HOME MONITOR ON (B)(6) 2014 ALTHOUGH THIS WARNING IS ACTUALLY DATED (B)(6) 2014 (SHOCKS WERE OFF ON THE DAY OF IMPLANT; THEY HAVE BEEN ACTIVATED AFTER THE IMPLANT). REPORTEDLY, ON (B)(6) 2014 SHOCKS WERE ON. MOREOVER, JUST AFTER THIS INTERROGATION, A FOLLOW-UP REPORT HAS BEEN GENERATED FOR NO REASON. THE CUSTOMER REQUESTED AN EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372051 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2786

    Patients

    Seq Age Sex Outcome Treatment
    1