BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3021255 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04232
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N0048522, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REFILL, THE ACTUAL RESIDUAL VOLUME OF ZERO WAS LESS THAN THE EXPECTED RESIDUAL VOLUME OF 1.7 ML. IT WAS DISCUSSED THAT THIS WAS WITHIN THE ACCEPTABLE VOLUME DISCREPANCY FOR A 40 ML PUMP. THE PATIENT HAD BACLOFEN WITHDRAWAL SYMPTOMS. THE PATIENT MISSED HIS PREVIOUS APPOINTMENT SO THE VOLUME WAS VERY LOW AT REFILL. THERE WERE NO ISSUES WITH THE PUMP. THE PUMP WAS FILLED WITHOUT ANY ISSUES AND THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123669 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1