BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 829657 · Received February 14, 2007

    Report

    Report Number
    2182207-2007-00505
    Event Type
    Malfunction
    Date Received
    February 14, 2007
    Date of Event
    October 2, 2006
    Report Date
    October 25, 2006
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIVISION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STUDY. PHYSICIAN SUSPECTS PUMP VALVE PROBLEM DUE TO PT SYMPTOMS OF WITHDRAWAL AS OF 2006. PT EXPERIENCED NAUSEA AND/OR VOMITING, PAIN, SWEATING, PLASTIC TASTE IN MOUTH, CHILLS, PLASTIC SMELL IN NOSE, DIARRHEA, TENSING UP ALL OVER, AND ACID REFLUX. THE PUMP WAS REPLACED ON 11-21-2006. SIDE PORT MYELOGRAM WAS DONE TO EXAMINE CATHETER ON 11-21-2006. MORPHINE 10 MG IM WAS TO BE GIVEN 10-25-2006. RESOLVED WITHOUT SEQUELAE 11-21-2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK LKK MEDTRONIC, INC., NEUROLOGICAL DIVISION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention PROGRAMMER MODEL 8840| LOT# UNK| IMPLANTED:| EXPLANTED: