BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203507 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04560
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012, THAT THE PATIENT WAS EXPERIENCING INCREASED PAIN. 10 DAYS LATER THE IMPLANTABLE PUMP WAS INTERROGATED AND FOUND TO BE ALARMING FOR LOW RESERVOIR VOLUME. PUMP WAS A 0 ML DRUG VOLUME. PUMP WAS TO REFILLED THE NEXT DAY BY THE HCP. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG. NO FURTHER INFORMATION WAS AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302798 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR