BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2133652 · Received June 16, 2011

    Report

    Report Number
    1000165971-2011-00224
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, A CONNECTION ISSUE OCCURRED DURING THE IMPLANTATION PROCEDURE OF THE ICD INVOLVED IN THIS MDR REPORT. WHEN THE SETSCREW WAS SCREWED TO TIGHTEN THE LEAD, ONLY ONE CLICK SOUND WAS CONFIRMED AND THE SCREWDRIVER SEEMED TO TURN FREELY. HOWEVER, THE LEAD WAS NOT COMING OUT FROM THE PORT BY A PULL TEST. THE PHYSICIAN TRIED TO UNSCREW BUT THE SCREWDRIVER WAS TURNING FREELY. ANOTHER SORIN SCREWDRIVER WAS USED BUT WITH THE SAME RESULTS. ANOTHER NON SORIN SCREWDRIVER WAS USED AND THE LEAD WAS FINALLY PULLED OUT OF THE ICD AFTER MANY DIFFICULTIES DURING UNSCREWING. THE DEVICE WAS RETURNED FOR ANALYSIS. ANOTHER SORIN ICD WAS SUCCESSFULLY IMPLANTED AND CONNECTED TO THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM VR 8250 2478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention