BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230546 · Received November 13, 2008

    Report

    Report Number
    2182207-2008-07425
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TWO BOLUSES WHILE IN THE CLINIC WITHOUT PAIN RELIEF. THE CATHETER WAS KINKED/OCCLUDED AT THE LUMBAR SITE. THE CATHETER WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER BUPIVACAINE (10 MG/ML), FENTANYL (600 MCG/ML), CLONIDINE (500 MCG/ML), AND COMPOUNDED BACLOFEN (100 MCG/ML) AT A RATE OF 8.0 MG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED: