BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 1936295 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01025
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    SORIN BIOMEDICA 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). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    CONNECTION ISSUES ASSOCIATED TO THE V IS-1 CHANNEL DURING AN IMPLANT ATTEMPT WERE REPORTED. REPORTED, THE LEAD COULD NOT BE INSERTED COMPLETELY, SINCE THE LEAD TIP WAS NOT VISIBLE. THE LEAD WAS REMOVED FROM THE PORT AND ATTEMPTED TO BE INSERTED AGAIN AND THE SET-SCREW WAS TIGHTENED, WHICH RESULTED IN A HIGH LEAD IMPEDANCE MEASUREMENT AND NO PACING OR SENSING. THE ATRIAL LEAD CONNECTOR WAS ATTEMPTED TO BE CONNECTED, AND IN THIS CASE, IT COULD BE FULLY INSERTED. ANOTHER DEVICE WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM DR 8550 2453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention