BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2053629 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01524
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED UNDERDOSE SYMPTOMS OF INCREASED PAIN. A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE PUMP HAD BEEN STALLING AND RECOVERING OVER THE LAST 2 DAYS. THE PHYSICIAN HAD PLANNED TO REPLACE THE PUMP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CATHETER: MODEL 8598A, LOT # N190685009| CATHETER: MODEL 8709SC, LOT # N192922018| IMPLANTED:| IMPLANTED:| EXPLANTED: