BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 807545 · Received January 18, 2007

    Report

    Report Number
    2182207-2007-00220
    Event Type
    Injury
    Date Received
    January 18, 2007
    Report Date
    January 8, 2007
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIVISION
    Product Code
    LKK
    PMA / PMN Number
    p860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT SINCE 11/2006, THE PT HAS BEEN EXPERIENCING VERY ALTERED MOOD SWINGS, LAUGHING AT NOTHING TO VERY VIOLENT OUT BURSTS WHERE HE ACTUALLY HURTS HIMSELF, ANXIETY ("HE WANTS ME AROUND AT ALL TIME, WHICH IS VERY UNUSUAL"), OCCASIONAL URINE RETENTION, MOUTH SPASMS, NOT BEING ABLE TO REMEMBER STUFF FROM DAY TO DAY, AND SEVERAL OTHER ODD CHANGES IN ATYPICAL BEHAVIOR. THE HCP HAS INDICATED THAT THE "PUMP IS FINE, IS WORKING PROPERLY, AND IS GETTING MEDICATION PROPERLY". CT SCAN WAS "CLEAN" AND EEG "TYPICAL" FOR CP PT. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK LKK MEDTRONIC, INC., NEUROLOGICAL DIVISION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention IMPLANTED| EXPLANTED| CATHETER MODEL 8709AA LOT# N004908535| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK