BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3062906 · Received April 12, 2013

    Report

    Report Number
    1000165971-2013-00200
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    A DEFIBRILLATION SHOCK WAS DELIVERED BY THIS ICD ON (B)(6) 2013 DUE TO VF DETECTION. ON (B)(6) 2013, PHYSICIAN REVIEWED THE EPISODES STORED IN DEVICE MEMORIES AND OBSERVED AN ABNORMAL ATRIAL NOISE PATTERN IN THE VF EPISODE, AS WELL AS IN THE FALLBACK MODE WITCH EPISODE RECORDED JUST AFTER THE VF. ADDITIONALLY, PHYSICIAN IS REQUESTING AN EXPLANATION AS FOR WHY THE DISPLAYED ATRIAL SENSING PERCENTAGE IS SUPERIOR TO 100%. ACCORDING TO PRELIMINARY ANALYSIS RESULTS, REPORTED BEHAVIORS ARE CONFIRMED AND A CONNECTION ISSUE OR LEAD ISSUE AT ATRIAL LEVEL IS SUSPECTED. RECOMMENDATIONS HAVE BEEN PROVIDED (EVALUATION OF THE BENEFIT OF A RE-INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157826 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM RF DR 9550 2596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention