BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242962 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07642
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAS NEVER HAD THERAPEUTIC EFFECT. THE PATIENT REPORTED HAVING A CSF LEAK SINCE THE TIME OF IMPLANT. A CT MYELOGRAM NOTED THE CFS LEAK AND A MASS. THE HCP HAD INCREASED THE DOSAGE, BUT DID NOT HELP THE PATIENT'S PAIN LEVEL. THE PATIENT HAD A BURNING SENSATION IN HER LEGS AND FEET. SHE HAD THE SAME SENSATION WITH IV MORPHINE IN THE EMERGENCY ROOM. WHEN THE DRUG WAS CHANGED TO DILAUDID, THE BURNING SENSATION CEASED. THE PATIENT HAD SURGERY SCHEDULED TO CORRECT THE CFS LEAK. ADDITIONAL INFORMATION RECEIVED FROM THE HCP INDICATED THE PATIENT HAD A REVISION DUE TO A KINK IN THE CATHETER, BUT WAS UNAWARE IF THE PROBLEM WAS FOUND AS A DIFFERENT SURGEON PERFORMED THE REVISION. NO FURTHER OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention CATHETER: MODEL 8709SC| EXPLANTED:| PROGRAMMER: MODEL 8840