BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED II

    MDR report key: 3042731 · Received April 3, 2013

    Report

    Report Number
    MW5029649
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    April 1, 2011
    Report Date
    April 3, 2013
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD A MEDTRONIC MODEL 8637-20 IMPLANTED ON (B)(6) 2010. THE PUMP HAS NOT BEEN WORKING FOR ALMOST 2 YEARS IT ALARMS EVERY 10 MINUTES. IT HAS BEEN VERY PAINFUL AROUND THE SITE SINCE IT WAS IMPLANTED. I WAS SUDDENLY DROPPED AS A PT AND LEFT TO DETOX ON MY OWN WHICH ENDED IN HOSPITALIZATION. THE PHYSICIAN WHO IMPLANTED IT HAS REFUSED TO REMOVE IT. MEDTRONIC ALSO REFUSED TO ASSIST. THIS IS ON RECORD WITH MY ATTORNEY. THIS DOCTOR HAS REFUSED 9 TIMES TO PROVIDE MY MEDICAL RECORDS. HE HAS ALSO REFUSED TO REFER ME TO ANOTHER PHYSICIAN, THE LAST DOCUMENTATION PLACED IN MY FILE WAS FALSE DOCUMENTATION AND MY ATTORNEY IS LOOKING INTO THIS CURRENTLY. WE HAVE CONTACTED EVERY DOCTOR IN THE STATE OF (B)(6) AND ALL REFUSE TO REMOVE IT OR SEE ME. EVERY DOCTOR STATES THE PERSON WHO PUT IT IN HAS TO TAKE IT OUT. I NOW HAVE A TUMOR ON MY LIVER THE SIZE OF A BASEBALL BUT CAN'T HAVE THE NEEDED MRI DUE TO THE PUMP. THE PUMP IS VERY PAINFUL, THE ALARMING EVERY 10 MINUTES DISRUPTS MY SLEEP AND FOCUS. IT ALARMS 24/7, EVERY 10 MINUTES. I HAVE A PAINFUL KNOT AT THE CATHETER SITE THAT HAS BEEN THERE SINCE DAY ONE. I HAVE NOW BEEN DIAGNOSED WITH FIBROMYALGIA. REPEATED INFECTIONS THEY COULD NOT LOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136348 MEDTRONIC SYNCHROMED II SYNCHROMED II, 115CC LKK 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| S