BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2041450 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02268
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED PUMP MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS REPORTED. THE LOGS SHOWED MULTIPLE STALLS AND RECOVERIES. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER FENTANYL AND CLONIDINE. ADDITION INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT # N076813007