BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUMP

    MDR report key: 3833779 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01442
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, AT THE TIME OF THIS REPORT, THE PATIENT WAS LOOKING FOR A SURGEON TO HAVE HIS TWO PUMPS EXPLANTED. THE PATIENT DID NOT CURRENTLY HAVE A PUMP HEALTHCARE PROVIDER (HCP).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WANTED TO HAVE THEIR PUMP REMOVED. IT WAS STATED THAT AT TIMES IT WORKED WELL, BUT THEY WOULD NEED TO GET INCREASED IN MEDICATION. IT WAS NOTED THE PATIENT HAS HAD SALINE IN THE PUMP SINCE (B)(6) 2013. IT WAS STATED THEY WERE TAKING ORAL NARCOTICS THAT WERE WORKING WELL FOR THEM. ADDITIONAL INFORMATION REPORTED THEY WERE NEARING END OF LIFE DUE TO NORMAL BATTERY DEPLETION. IT WAS STATED THE PATIENT DIDN¿T WANT THE PUMP BECAUSE THEY WANTED TO MOVE OFF PUMPS. IT WAS STATED THAT OVER THE LAST 10 YEARS THE PATIENT HAD MORE ISSUES THAN THEY WOULD LIKE. IT WAS STATED SOME WAS THE SURGEON¿S FAULT, BUT THEY DID NOT PROVIDE ANY MORE INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT THE ISSUES OVER THE LAST 10 YEARS, BUT WAS NOT AVAILABLE FOR THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310138 UNKNOWN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR