BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2668934 · Received July 25, 2012

    Report

    Report Number
    3004209178-2012-06057
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Report Date
    June 27, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-9, LOT# N213886, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ISSUES WITH THE PERSONAL THERAPY MANAGER (PTM). IT WAS REPORTED THAT WHEN THE PATIENT ASKED THE DOCTOR TO CHANGE THE SETTINGS ON THEIR PUMP THE DOCTOR WAS UNABLE TO DO SO, POSSIBLY DUE TO THE PTM. IT WAS REPORTED THAT AFTER THE DOCTOR ADDED A NEW MEDICATION TO THE PUMP THE PATIENT'S PTM STOPPED WORKING. THE DOCTOR WANTED THE PATIENT TO GO INTO THE OFFICE TO CHANGE THE SETTINGS ON THE PUMP BECAUSE THE NEW MEDICATIONS WERE "SET TOO HIGH." THE PATIENT WAS CONCERNED SINCE THE PREVIOUS TIME THE DOCTOR WAS UNABLE TO CHANGE THE SETTINGS THAT HE WOULD AGAIN NOT BE ABLE TO CHANGE THEM AND THE PATIENT "DID NOT WANT TO GO IN TO SEE HIM AND HAVE NOTHING DONE BECAUSE THE SALES REP (MANUFACTURER REPRESENTATIVE) NEEDED TO BE THERE TO HELP CHANGE THE SETTINGS." IT WAS ALSO REPORTED THAT THE PATIENT WANTED HELP TO GET HIS PTM WORKING AS SOON AS POSSIBLE BECAUSE THE MEDICATIONS WERE MAKING HIM "SICK." THE MEDICATIONS USED IN THE PUMP WERE MORPHINE (CONCENTRATION AND DOSE UNKNOWN) AND OTHER UNKNOWN MEDICATIONS. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS UNAVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1