BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3010454 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03907
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, EIGHT DAYS PRIOR TO REPORT, THERE HAD BEEN A VOLUME DISCREPANCY WITH THE PATIENT'S PUMP. AT THE PATIENT'S SECOND REFILL, THE EXPECTED RESIDUAL VOLUME WAS 9ML, BUT THE PUMP WAS FOUND TO BE EMPTY BESIDES A FEW DROPS. ALSO, THE PATIENT HAD BEEN ADMITTED ABOUT THREE WEEKS PRIOR TO REPORT FOR WHAT WAS THOUGHT TO BE A "GI BUG", BUT COULD HAVE BEEN WITHDRAWAL DUE TO AN EMPTY PUMP. HE HAD PRESENTED WITH NAUSEA, SWEATING, AND CHILLS. ON THE DAY OF REPORT, THE PATIENT HAD BEEN SEEN BY ANOTHER HCP FOR INCREASED PAIN. IT WAS NOTED THAT THERE HAD BEEN NO ISSUES WITH THE PATIENT'S FIRST REFILL. THE HEALTHCARE PROFESSIONAL (HCP) HAD NO DIFFICULTY FILLING THE PUMP AND KNEW SHE HAD BEEN IN THE RESERVOIR DURING THE REFILL, DUE TO THE PATIENT'S THIN PHYSIQUE. ADDITIONALLY, THE PATIENT HAD NOT EXPERIENCED ANY OVERDOSE SYMPTOMS, WHICH WOULD HAVE SIGNIFIED INJECTION OUTSIDE THE RESERVOIR. THERE HADN'T BEEN ANY PROGRAMMING CHANGES OR KNOWN MEDICAL PROCEDURES WHICH COULD HAVE CAUSED THE DISCREPANCIES. THE HCP SUSPECTED THAT THE PATIENT COULD HAVE WITHDRAWN THE MEDICATION MANUALLY. THE PATIENT WAS SCHEDULED TO COME BACK INTO THE CLINIC ON THE FOLLOWING MONDAY FOR A "VOLUME CHECK" AND HAD BEEN USING LOW-DOSE OXYCODONE ORALLY. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THAT THE RESERVOIR VOLUME HAD BEEN ACCURATE AT THE PATIENT'S FOLLOW-UP APPOINTMENT. A NEPHROLOGIST ATTRIBUTED THE INCREASED BACK PAIN TO THE PATIENT'S NEUROLOGIC HISTORY AND A NEWLY DIAGNOSED KIDNEY DISEASE. THE DRUG USED IN THIS SYSTEM WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113908 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1