BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAR - 1 HR REFIL, 50ML DHR, CLOSED TIP CATHETER

    MDR report key: 177785 · Received July 15, 1998

    Report

    Report Number
    2021898-1998-00061
    Event Type
    Injury
    Date Received
    July 15, 1998
    Date of Event
    December 20, 1997
    Report Date
    June 8, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE BECAME OCCLUDED. THE PT WAS UNABLE TO ACTIVATE THE DEVICE AND THE TREATING PHYSICIAN HAD DIFFICULTY FILLING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAR - 1 HR REFIL, 50ML DHR, CLOSED TIP CATHETER Implant IMPLANTED PT CONTROLLED ANALGESIA PUMP LKK MEDTRONIC PS MEDICAL NA K1672

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention