BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2190982 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00279
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    April 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE SCREW OF THE ATRIAL CHANNEL WAS EXTENDED WITHIN THE CONNECTION PORT UPON RECEPTION. REPORTEDLY, THE PHYSICIAN RETRACTED THE SET-SCREW, AND THE SUBJECT DEVICE WAS SUBSEQUENTLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM VR 8250 2497

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention