BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202700 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01102
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 4, 2012
    Report Date
    May 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL AND THE PUMP WAS EMPTY FOR 9 DAYS. THE PATIENT REPORTEDLY WAS "DETOXING" WHICH WAS LATER CLARIFIED AS GOING THROUGH WITHDRAWALS. IT WAS STATED THAT THE PATIENT WAS "PRETTY SICK" AND HAD SEVERE PAIN. IT WAS NOTED THAT THE PATIENT HAD BEEN REFILLED SINCE THEN AND THE "PUMP WAS WORKING." A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2012. IT WAS STATED THAT HE PATIENT CURRENTLY WAS HOMELESS AND WAS "LIVING IN HER CAR." THE CALLER STATED THAT SHE COULD FEEL THE PUMP "SPITTING STUFF OUT", WHICH WAS CLARIFIED AS THE PUMP WAS MOVING (WORKING). THE PATIENT HAD GAINED AND LOST WEIGHT. THE PATIENT VERIFIED THAT THE PUMP HAD NOT FLIPPED AND THAT THE HEALTHCARE PROVIDER (HCP) WAS ABLE TO ACCESS THE PUMP (USUALLY TOOK 20 MINUTES). THE PATIENT DENIED HEARING ANY AUDIBLE ALARMS. THERE WAS NO INDICATION OF ANY RESERVOIR VOLUME DISCREPANCIES. IT WAS ALSO STATED THA T THE PATIENT SLEPT MOST OF THE WITHDRAWAL SYMPTOMS OFF DURING THAT TIME. IT WAS KNOWN THAT MORPHINE WAS THE MAIN DRUG IN THE PUMP. THE PATIENT COULD NOT RECALL WHAT ELSE WAS IN THE PUMP. THE PATIENT OUTCOME WAS UNKNOWN. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301720 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR