BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1081353 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04356
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    March 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004/S56
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PAIN IN HER LEGS FOR THREE MOS BEFORE THE REPORT. A LOSS OF THERAPEUTIC EFFECT AND DIFFICULTY WALKING WAS ALSO REPORTED. THE PT HAD BEEN EVALUATED BY THE HLTH PROFESSIONAL AND AN MRI WAS PLANNED TO RULE OUT INFLAMMATORY MASS. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRATHECAL DILAUDID| IMPLANTED| INTRATHECAL CATHETER MODEL 8709 LOT# N107117023| PROGRAMMER MODEL 8840 LOT # UNK| EXPLANTED