BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3811752 · Received May 15, 2014

    Report

    Report Number
    1000165971-2014-00270
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 18, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPON INTERROGATION, A WARNING ABOUT 0J ENERGY DURING SHOCK DELIVERY WAS DISPLAYED. HOWEVER, NO DATA ABOUT ANY SHOCK WAS AVAILABLE IN DEVICE MEMORY AND THE DATE OF THE SHOCK WAS BEFORE IMPLANTATION. FILES CORRESPONDING TO POST IMPLANT CHECK DID NOT SHOW THIS WARNING. PRELIMINARY ANALYSIS CONCLUDED SOME DATA WERE ALTERED IN DEVICE MEMORY. IT SHOULD BE NOTED THE PATIENT HAD RADIOTHERAPY (DATE UNKNOWN). ON (B)(6) 2014, THE DEVICE WAS RE-INITIALISED.

    Description of Event or Problem · 1

    UPON INTERROGATION, A WARNING ABOUT 0J ENERGY DURING SHOCK DELIVERY WAS DISPLAYED. HOWEVER, NO DATA ABOUT ANY SHOCK WAS AVAILABLE IN DEVICE MEMORY AND THE DATE OF THE SHOCK WAS BEFORE IMPLANTATION. FILES CORRESPONDING TO POST IMPLANT CHECK DID NOT SHOW THIS WARNING. PRELIMINARY ANALYSIS CONCLUDED SOME DATA WERE ALTERED IN DEVICE MEMORY. IT SHOULD BE NOTED THE PATIENT HAD RADIOTHERAPY (DATE UNKNOWN). ON (B)(6) 2014, THE DEVICE WAS RE-INITIALISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290350 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2552

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention