BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2880083 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12053
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY AND POSSIBLE POCKET FILL WAS REPORTED. THE PATIENT HAD A REFILL AND SHORTLY AFTER COMPLAINED OF POOR EYE SIGHT ALONG WITH FEELING SLEEPY. THE OVERDOSE SYMPTOMS THE PATIENT EXPERIENCED WERE ALTERED MENTAL STATUS AND SOMNOLENCE. 911 WAS CALLED AND THE AMBULANCE TOOK THE PATIENT TO THE LOCAL HOSPITAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT RECEIVED A NARCAN DRIP. IT WAS NOTED, THE EXPECTED VOLUME WAS 20ML AND THE ACTUAL VOLUME WAS 15ML. THE PUMP WAS REPROGRAMMED. THE HCP ORDERED A DECREASE IN THE DAILY DOSE FROM 1.8MG/DAY TO 0.750MG/DAY OF DILAUDID. THE PATIENT OUTCOME WAS NOTED TO BE ALIVE WITH INJURY. THE PUMP DELIVERED DILAUDID, CLONIDINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R