BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3965204 · Received July 29, 2014

    Report

    Report Number
    3007566237-2014-02107
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT INTO WITHDRAWAL ON (B)(6) 2014 WHEN HIS PUMP BECAME EMPTY AND HE WAS THEN ADMITTED INTO THE HOSPITAL. IT WAS NOTED THEY GAVE HIM ORAL MEDICATIONS AND THE PATIENT ¿HAD A BAD LIVER TO BEGIN WITH¿ BECAUSE HE HAD BEEN USING THE PUMP INSTEAD OF PILLS ¿TO SAVE MY LIVER A LITTLE BIT¿ AND NOW THE PATIENT WAS BACK TO WHERE HE WAS BEFORE THE PUMP WAS IMPLANTED. IT WAS ALSO REPORTED THE PATIENT WAS DUE FOR A REFILL ON THE DATE OF THIS REPORT. IT WAS FURTHER REPORTED THE PATIENT WENT INTO WITHDRAWAL SYMPTOMS ON (B)(6) 2014 AND ¿I¿M A DRUG ADDICT.¿ IT WAS REPORTED THE HOSPITAL WAS TELLING THE PATIENT THERE WAS SOMETHING WRONG WITH THIS PUMP, BUT THE PATIENT KNEW IT WAS JUST OUT OF MEDICATION AND NEEDED ¿SOMEONE TO COME OUT AND FILL IT.¿ IT WAS NOTED THEY DID AN MRI ON (B)(6) 2014 AND IT SHOWED EVERYTHING WAS RUNNING AND CONNECTED, BUT ¿THEY WANT TO TAKE IT OUT OF ME, BUT IT¿S THE ONLY THING THAT IS CONTROLLING THE NEUROPATHY IN MY FEET.¿ IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE (REP) WOULD BE GOING TO THE CLINIC ON THE DATE OF THIS REPORT AND WOULD ADDRESS THE SITUATION WITH THEM. THE PUMP WAS BEING USED TO DELIVER BUPIVACAINE AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) DECREASED THE PATIENT'S PUMP DOSAGE LAST MONTH AND SINCE THEN HE HAS HAD MORE PAIN. THE PATIENT WAS HOPING THIS NEW DOCTOR COULD GIVE HIM THE PREVIOUS DOSAGE, WHICH GAVE HIM PAIN RELIEF. THE PATIENT'S PRIOR HCP HAD "INSINUATED THAT HE HAD DRUG SEEKING BEHAVIOR" AND POINTED OUT THE FACT THAT HE HAD 190MG OF ORAL MORPHINE PRESCRIBED TO HIM AND THE DOCTOR HAD DISMISSED THE PATIENT. IT WAS ALSO REPORTED THE PATIENT ONLY TAKES DRUGS PRESCRIBED BY HIS HCP. IT WAS NOTED THE PATIENT GOT ANGRY AND LEFT AND HE DID NOT KNOW IF ANYTHING WAS CHANGED ON THE PUMP ON THE DATE OF THIS REPORT. IT WAS REPORTED THE PATIENT HAD HIS "VCI CHECKED FROM THE HOSPITAL STATING HE WAS ON 180MG OF MORPHINE AND 160MG OF OXYCONTIN IN THE HOSPITAL, BUT NOT OUTSIDE THE HOSPITAL." IT WAS NOTED THE HOSPITAL STAY WAS RELATED TO THE PUMP THERAPY AND THE PATIENT WAS IN THE HOSPITAL TWO MONTHS AGO BECAUSE "HE WAS SICK." THE PATIENT NOW NEEDED TO FIND A HCP THAT WAS WILLING TO FILL THE PUMP AND WORK WITH HIS INSURANCE. IT WAS NOTED THE HCP LEFT SOME BUPIVACAINE IN THE PUMP SO HE COULD STILL HAVE RELIEF UNTIL HE FOUND A NEW HCP, BUT THE PATIENT WAS UNSURE IF THIS WAS STILL THE CASE WITH HIS PUMP. IT WAS FURTHER REPORTED BY THE PATIENT THAT HE HAD NO LONGER HAD BUPIVACAINE AT ALL IN THE PUMP BECAUSE IT WAS NOT APPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441836 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization