BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4037714 · Received August 26, 2014

    Report

    Report Number
    3004209178-2014-15902
    Event Type
    Injury
    Date Received
    August 26, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N162898, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL FOR TWO TO THREE WEEKS WITH SYMPTOMS OF NAUSEA, HEADACHE, GENERALIZED WEAKNESS, LOSS OF APPETITE, WEIGHT LOSS, TREMORS, SLEEPING "ALL THE TIME" OR INABILITY TO STAY AWAKE. THE HEALTHCARE PROFESSIONAL (HCP) DID NOT KNOW WHAT WAS WRONG WITH THE PATIENT AND WANTED TO RULE OUT THE DRUG INFUSION PUMP. THE MANUFACTURER'S FIELD STAFF WAS REQUESTED TO CONFIRM THE PUMP STATUS. THE PUMP WAS INTENDED TO INFUSE AN UNKNOWN DRUG. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE IF ANY INTERVENTIONS WERE PERFORMED, THE RESULTS, AND PATIENT OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE DELIVERED DILAUDID. THE PATIENT'S MANAGING PUMP HEALTH CARE PROVIDER (HCP) DIDN'T KNOW WHAT SYMPTOMS THE PATIENT EXPERIENCED AND NOTED THE PATIENT HAD BEEN AT THE ER (EMERGENCY ROOM). THE CAUSE OF THE EVENT WAS UNKNOWN TO THE HCP AS WELL. THE PATIENT WAS SEEN IN THE ER, EVALUATED AND THERE WAS NO PUMP FAILURE OR COMPLICATION NOTED. INITIALLY, IT WAS ALSO NOTED THE PATIENT WAS ADMITTED HOWEVER IT WAS THEN CROSSED OUT AND NOTED TO BE AN ERROR. NO CHANGES WERE MADE TO THE PUMP DOSAGE OR RATE AND THEIR LAST REFILL THAT HAD OCCURRED ON (B)(6) 2014 HAD BEEN UNEVENTFUL. IN TERMS OF HOW THE PATIENT WAS NOW DOING, THEY HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517145 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization