BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2133553 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04443
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 18, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (METALLIC TASTE).

    Description of Event or Problem · 1

    THE PATIENT'S PUMP HAD RUN DRY ON (B)(6) 2011, AND HE SUFFERED WITHDRAWAL SYMPTOMS. ON (B)(6), THE PATIENT HAD A "METALLIC TASTE" IN HIS MOUTH AND TROUBLE BREATHING AFTER HAVING HIS PUMP REFILLED WITH NORMAL SALINE. HE STARTED FEELING A LITTLE WORSE THAT EVENING. THE PATIENT WENT TO THE ER (EMERGENCY ROOM) AND WAS GIVEN ORAL MORPHINE, WHICH HELPED HIM FEEL A LITTLE BETTER. THE PUMP WAS ALARMING AND THE PATIENT DID NOT HAVE A MANAGING PHYSICIAN AT THE CLINIC HE WENT TO. THE PATIENT WAS VERY CONCERNED ABOUT STARTING THE PUMP BACK UP, EVEN ON MINIMUM RATE DUE TO INSURANCE PROBLEMS. THE PATIENT RECENTLY LOST HIS PRIVATE INSURANCE AND HIS HEALTH INSURANCE WILL NOT PAY FOR THE MEDICATION FOR HIS PUMP REFILL. THE PATIENT WAS UNCOMFORTABLE STARTING THE PUMP BACK UP SINCE IT WOULD TECHNICALLY START ADMINISTERING MORPHINE AGAIN SINCE A SMALL AMOUNT WAS STILL LEFT IN THE PUMP. THE PATIENT CONTEMPLATED HAVING HIS PUMP REMOVED. 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 42 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N174320007