BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3031500 · Received April 2, 2013

    Report

    Report Number
    3007566237-2013-00989
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL APPOINTMENT AND HAD NOT HAD HER PUMP FILLED DURING THE LAST MONTH. AT THE TIME OF REPORT, THE PATIENT WAS IN THE EMERGENCY ROOM WITH 'OTHER ISSUES GOING ON.' THE PATIENT WAS FEELING NAUSEOUS AND WEAK, THOUGH IT WAS UNCLEAR IF THESE SYMPTOMS RELATED TO THE 'OTHER ISSUES.' THE REPORTER FELT THAT THE PUMP SHOULD BE DRY AT THAT TIME. IT WAS REPORTED THAT AFTER ACCESSING THE RESERVOIR, THE HEALTHCARE PROFESSIONAL (HCP) WAS ASPIRATING AIR AND WAS NOT ABLE TO INJECT ANYTHING. HOWEVER, THE HCP REPOSITIONED THE NEEDLE AND FOUND THAT SHE WAS ABLE TO INJECT THE 20ML. AT THE PATIENT'S LAST REFILL ON (B)(6) 2011, THE RESERVOIR VOLUME WAS SET TO 16ML. IT WAS NOTED THAT THE PUMP ALARM HAD NOT SOUNDED. UPON INTERROGATION, IT WAS SEEN THAT 4.6ML SHOULD HAVE STILL BEEN PRESENT IN THE RESERVOIR. THE REPORTER FELT THAT THERE WAS STILL DRUG IN THE PUMP TUBING AS THE PATIENT HAD NOT EXPERIENCED ANY STIFFNESS OR SEIZURES. IT WAS STATED THAT THE PATIENT WAS NOT IN THE HOSPITAL FOR THE EMPTY PUMP. THE HCP WOULD FOLLOW-UP WITH THE PATIENT LATER THAT DAY. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135229 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR