BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230826 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06738
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    May 8, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS IN A TANNING BED ON (B)(6) 2011 FOR ABOUT 8 MINUTES AND GOT OVERHEATED. ABOUT 10-15 MINUTES LATER THE PATIENT'S SPINE FELT TINGLY, THE PATIENT'S PAIN WAS DECREASED SIGNIFICANTLY, AND HE HAD SLURRING OF SPEECH FOR A SHORT TIME. THE DRUG USED IN THE PATIENT'S PUMP WAS MORPHINE (20 MG/ML AT A DOSE OF 6.593 MG/DAY). THERE WERE NO INTERVENTIONS. THE PATIENT CALLED AFTER THE INCIDENT WAS RESOLVED. THE PATIENT NOTED HE IS GETTING GOOD PAIN RELIEF; RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN OVERDOSE. THE PT WENT INTO A TANNING BED AND GOT OVERHEATED WHICH CAUSED HIS PUMP TO DELIVER TOO MUCH DRUG. THE PT RECOVERED DROM THE INCIDENT AND WAS DOING FINE AT THE TIME OF THIS REPORT. THE PT PLANNED TO AVOID TANNING BEDS IN THE FUTURE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N127438012| EXPLANTED: