BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150777 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08754
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FURTHER REPORTED THAT WITH THE OVERDOSE OF MEDICATION RIGHT AFTER IMPLANT THE PATIENT WAS UNRESPONSIVE. THE PATIENT NOTED THE HEALTH CARE PROVIDER WAS GIVING THE PATIENT HYDROMORPHONE IN THE PUMP, DILAUDID, SLEEPING PILLS, AND VALIUM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED YESTERDAY AND THE PATIENT WAS CURRENTLY GROGGY BECAUSE THE PUMP DOSE SEEMED TO BE ¿TOO MUCH FOR THE PATIENT¿. THE HEALTH CARE PROVIDER WANTED THE PUMP TO BE LOWERED TO MINIMUM RATE UNTIL THEY COULD GET THE SITUATION UNDER CONTROL. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THE PUMP WAS TURNED DOWN TO MINIMUM RATE. THE PATIENT HAD BEEN ¿SNEAKING¿ PAIN MEDS AND THERE WAS NOTHING WRONG WITH THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251072 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention