BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2251022 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07606
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    September 2, 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

    FINAL DEVICE ANALYSIS FOR THE PUMP REVEALED NO ANOMALY FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP HAD NOT BEEN USED, BUT IT HAD A PENDING ALARM SIGNAL ON. THE PUMPS HAD NOT BEEN IMPLANTED IN A PT AND ARE BEING RETURNED FOR ANALYSIS. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1