BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2992078 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00703
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A VOLUME DISCREPANCY IN THE PATIENT'S PUMP. OVER THE EIGHT MONTHS PRIOR TO REPORT, THE RESERVOIR HAD VOLUME DISCREPANCIES OVER 25% MORE THAN THE EXPECTED RESERVOIR VOLUME. A DYE STUDY HAD BEEN PERFORMED AND NO PROBLEMS WERE SEEN. ADDITIONALLY, A ROTOR STUDY WAS PERFORMED AND IT WAS STATED THAT THE ROTORS ONLY MOVED 45 DEGREES INSTEAD OF 60; HOWEVER, IT WAS NOTED THAT IT ISN'T UNUSUAL TO SEE LESS THAN 60 DEGREE MOVEMENT IN THIS SCENARIO. THE DRUG USED IN THIS SYSTEM WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98002 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1