BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED II

    MDR report key: 1520508 · Received October 26, 2009

    Report

    Report Number
    2182207-2009-07755
    Event Type
    Other
    Date Received
    October 26, 2009
    Date of Event
    September 28, 2009
    Report Date
    September 28, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WENT THROUGH AIRPORT SECURITY TO TRAVEL VIA AIRPLANE TO A DIFFERENT STATE. THE PT'S PUMP WAS FILLED ONE WEEK BEFORE SHE LEFT FOR VACATION. THE PT EXPERIENCED AN OVERDOSE WITH THE FOLLOWING SYMPTOMS: ANXIETY AND DIZZINESS. THE PT NOTED A CHANGE IN THERAPY EFFECT; DID NOT FEEL WELL, WAS NOT ABLE TO EAT, WAS THROWING UP AND HAD NAUSEA. IT WAS ALSO REPORTED THAT THE BACK OF THE LEG ON THE LEFT SIDE WAS CAUSING MORE PAIN THAN USUAL. THE HCP LATER REPORTED THAT THE PT WAS "VERY ANXIOUS OVER TRIP. ANXIETY INCREASES HER PAIN". THE PUMP CONTAINED MORPHINE 20 MG/ML AT A DAILY DOSE OF 10 MG/DAY. THE PT WAS INFORMED AT THE AIRPORT THAT THE SCANNING DEVICES MAY HAVE SHUT OFF HER PUMP. THE PT DID NOT HAVE THIS EVALUATED BY ANYONE INCLUDING THE REPORTING HCP. PER THE HCP, THERE WAS NO INJURY. THE REPORTER DID NOT ATTRIBUTE THE EVENT TO THE DEVICES.

    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 78 YR CATHETER: MODEL 8709, LOT# J12343R03| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: