BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202623 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00670
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 1, 2012
    Report Date
    May 2, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8711, LOT# J11174R16, IMPLANTED: 2002-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS A ¿COUPLE OF MONTHS¿ PAST THEIR REFILL DATE AND THE STABILITY OF THE DRUG IN HER PUMP HAD EXPIRED. THERE WERE 2 ML OF LIORESAL REMAINING IN THE PUMP AND THERE WERE 11 MONTHS REMAINING UNTIL THE PUMP¿S ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS COMPLIANT WITH HER HEALTH CARE PROVIDERS (HCPS), BUT LIVES SEVERAL HOURS AWAY AND HAS TO TAKE THE BUS TO APPOINTMENTS. THE HCP DID NOT WANT TO REPLACE OR REFILL THAT PATIENT¿S PUMP DUE TO THIS TRAVEL DIFFICULTY. THE HCP WAS GOING TO ¿SHUT THE PUMP OFF¿ TO AVOID ALARMS OCCURRING. THE PATIENT WAS GOING TO START ORAL THERAPY. 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
    301308 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR