BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2140971 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04635
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERDOSE/ "JOLT" EVERY 6-7 DAYS WITH SLEEPINESS, HALLUCINATIONS, AND A METALLIC TASTE IN HIS MOUTH. THESE SYMPTOMS WERE INTERMITTENT AND HAVE OCCURRED SINCE THE PUMP WAS IMPLANTED. PER THE REPORTER, THE PATIENT DESCRIBED THE "JOLT" AS TOO MUCH MEDICATION. THE OTHER DAYS, THE PATIENT FELT FINE AND HAD BEEN ABLE TO RETURN TO NORMAL EVERY DAY ACTIVITIES. THE PATIENT WAS NOT ON ANY OTHER ORAL MEDICATIONS. IT WAS NOTED THAT A CAP STUDY IN THE PAST WAS NEGATIVE. THERE HAVE BEEN NO VOLUME DISCREPANCIES. A DYE STUDY WAS PERFORMED AT THE END OF MAY. THE CATHETER WAS EASY TO ASPIRATE AND THE STUDY LOOKED NORMAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL EXPERIENCING THESE INTERMITTENT EVENTS. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention CATHETER: MODEL 8709SC, LOT# N228140006.| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N228140006| IMPLANTED: