BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1985500 · Received January 7, 2011

    Report

    Report Number
    1000165971-2011-00012
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    October 4, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE PROGRAMMER FILES WERE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR WAS INTERROGATED UPON SCHEDULED FOLLOW-UP ON (B)(6) 2010. THE PHYSICIAN REPORTED THAT HE OBSERVED RECORDED EPISODES OF VENTRICULAR OVERSENSING, CLASSIFIED AS VF / NON-SUSTAINED (EG. (B)(6) 2010 - 20:03).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM VR 8250 2427

    Patients

    Seq Age Sex Outcome Treatment
    1