BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3182093 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10703
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT HAD AN ADJUSTMENT AND A BRIDGE BOLUS WAS DONE. THE PATIENT WAS NOT ABLE TO USE HIS PERSONAL THERAPY MANGER (PTM) FOR APPROXIMATELY 140 HOURS THERE AFTER. THIS NOW PAST, THE PTM WAS STILL SHOWING THE PATIENT¿S OLD REFILL DATE. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED AN IMPROPER SYNCHRONIZATION TO HIS PTM AT HIS LAST PUMP REFILL. THIS HAS BEEN CORRECTED AND HE WAS DOING FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE REFILL DATE WAS NOT ACCURATE ON THE PERSONAL THERAPY MANAGER (PTM). THE REFILL DATE HASN'T MATCHED SINCE THE LAST REFILL THAT WAS DONE ABOUT 7-10 DAYS PRIOR. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THE PUMP WAS DELIVERING BUPIVACAINE AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281849 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR