BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL PAIN PUMP

    MDR report key: 11045979 · Received December 18, 2020

    Report

    Report Number
    MW5098459
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    October 1, 2016
    Report Date
    December 17, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A W/C INJURY 2-2000. HAD LUMBAR FAILED FUSION, TREATED OVER THE YEARS WITH ORAL RX. PHYSICAL THERAPY, ESI, STIMULATOR IMPLANT, INTRATHECAL PUMP. HAD VERY GOOD PAIN CONTROL FOR 5 YEARS WHEN MY PAIN MGMT DR STATED HE WOULD NO LONGER TREAT ME, RECOMMENDED 3 DOCTORS. I HAVE NOT FOUND ANY DOCTOR WILLING TO TAKE OVER MY PUMP DUE TO LIABILITY. I HAVE ASKED MY W/C ADJUSTER TO ASSIST. ALSO, THE (B)(6) WORKER'S COMPENSATION COMMISSION, MEDTRONIC. I HAVE ENDURED SEVERE WITHDRAWALS, ER DOCTORS ONLY RX 2 DAYS OF TYLENOL #3. MY PAIN IS UNBEARABLE. I RECEIVE (B)(6) I THAT I CAN BARELY LIVE ON AFTER (B)(6) PREMIUM I RECEIVE $ (B)(6)/MO. I HAD TO RESORT TO BUYING METHADONE MYSELF JUST TO RELIEVE WITHDRAWALS, I TAKE 10MG A DAY. I HAVE EVEN ASKED MY PRIMARY CARE DR WITH (B)(6) WITH NO SUCCESS. I ASKED THE DR OFFICE TO LET DR (B)(6) KNOW THAT I HAVEN'T FOUND A DR BUT HIS STAFF WILL NOT INFORM HIM DUE TO I AM NO LONGER A PATIENT. I HAVE TRIED EVERY SOURCE SHORT OF AN ATTORNEY. ALL I WANT IS PAIN TREATMENT OR AT LEAST A DOCTOR WILLING TO REMOVE THE PUMP. THE ALARM STILL GOES OFF AND AT TIMES CAUSES MUCH ANXIETY. PLEASE ADVISE. DEPLETED INTRATHECAL PUMP. WC: (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499054 INTRATHECAL PAIN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC, INC. 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other