BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4802613 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09845
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8590-1, LOT# N191753, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_CATH, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER REPORTED AT THE REFILL THE DAY OF THE REPORT A ¿LITTLE EXTRA VOLUME¿. THE EXPECTED VOLUME WAS 4.5ML AND THE ACTUAL VOLUME WAS 7ML, TYPICALLY THE VOLUME DISCREPANCY WAS +/-1ML. THERE WERE NO PATIENT SYMPTOMS OR ISSUES AND NO PAIN ISSUES REPORTED. AN MRI WAS DONE RECENTLY AND THE MOTOR STALL WAS NOTED IN THE LOGS. THE PUMP WAS USED TO DELIVER MORPHINE. INTERVENTIONS AND PATIENT OUTCOME NOT REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347386 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR