BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1201522 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06648
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD "LOST PAIN RELIEF". THE HCP EXPERIENCED DIFFICULTY ASPIRATING FLUID THROUGH THE CATHETER ACCESS PORT. THE CATHETER WAS FOUND TO BE "OUT OF THE INTRATHECAL SPACE". THE CATHETER WAS REPAIRED. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| CATHETER MODEL 8709SC LOT# N110510009| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED: