BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3881406 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01701
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# L50556, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HEARD AN ALARM STARTING THREE DAYS PRIOR TO REPORT, BUT THIS HAD NOT BEEN CONFIRMED BY TELEMETRY. THE PATIENT ALSO REPORTED A CHANGE IN THERAPY EFFECT, AND INCREASED PAIN THAT STARTED ALMOST TWO YEARS PRIOR TO REPORT. IT WAS NOTED THAT WAS HOW THEY FOUND OUT MORE ABOUT THE PATIENT'S BACK AND DISC ISSUES. THE PATIENT HAD A MYLEOGRAM PERFORMED TWO WEEKS PRIOR TO REPORT WHICH FOUND HE HAD STENOSIS OF THE SPINE. THE PATIENT ALSO HAD ANOTHER HERNIATED DISC. IT WAS NOTED THAT THE "MEDICINE WAS NOT GOING WHERE IT WAS SUPPOSED TO". THERE WAS REPORTEDLY NOTHING WRONG WITH THE CATHETER, BUT THE PATIENT HAD A BLOCKAGE IN THE SPINAL CANAL. IT WAS NOTED THAT THIS ISSUE STARTED A YEAR AND A HALF AGO, BUT BECAUSE IT WAS NOT RELATED TO THE PUMP, THEY HADN'T REPLACED THE IT YET. THERE WAS REPORTEDLY NO VOLUME DISCREPANCY SO THEY WERE NOT CONVINCED THERE WAS A PROBLEM. THE PATIENT STATED THAT DETERIORATION OF THE SPINE WAS THE ISSUE, NOT THE CATHETER. THE PATIENT'S PUMP WAS THEN REPORTEDLY INFUSING BACLOFEN AND FENTANYL. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT THIS COMING (B)(6) DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THAT THEY HAVE "AN ELECTIVE REPLACEMENT INDICATOR (ERI) THAT IS BASICALLY (B)(6)". HOWEVER THE PATIENT NOTED THAT THEY "DON¿T THINK IT'S WORKING BECAUSE THE LEVEL OF PAIN IS ASTRONOMICAL RIGHT NOW." IT WAS NOTED THAT IT HAD BEEN THAT WAY FOR ABOUT TWO WEEKS. THE PATIENT REPORTEDLY DID NOT FEEL WITHDRAWAL SYMPTOMS AS THEY WERE TAKING ORAL MORPHINE. IT WAS NOTED THAT THE PATIENT WAS TO SEE THEIR DOCTOR (B)(6) 2014. THE PATIENT'S LAST REFILL WAS DONE IN (B)(6) AND THE PRINTOUT CAME UP WITH ERI IN 1 MONTH WITH THE ALARM DATE BEING (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD BEEN EXAMINED (B)(6) 2014. IT WAS NOTED THAT THE LAST CHANGES WERE MADE TO THE PUMP ON (B)(6) 2014. THE PUMP WAS INFUSING FENTANYL AND BUPIVACAINE. IT WAS LATER REPORTED THAT THIS PHYSICIAN HAD NOT SEEN THE PATIENT SINCE (B)(6) 2013 AS THE PATIENT DID NOT FOLLOW-UP WITH THE PHYSICIAN'S OFFICE. THE PATIENT REPORTEDLY DID NOT SHOW UP FOR THE PUMP REFILL APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357702 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR