BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2931819 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00298
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDOSE OCCURRED. FIVE TO TEN MINUTES FOLLOWING A NORMAL REFILL ON THE DAY OF THE REPORT, THE PATIENT EXPERIENCED RESPIRATORY DIFFICULTIES. THE PATIENT "TURNED BLUE" AND WENT INTO RESPIRATORY ARREST. MOUTH-TO-MOUTH WAS GIVEN BY THE PHYSICIAN AND UNTIL PARAMEDICS ARRIVED AND NARCAN WAS AVAILABLE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND HOSPITALIZED. THE PUMP WAS PROGRAMMED TO MINIMUM RATE AND LATER TURNED UP TO 50% OF THE ORIGINAL DOSE. IT WAS NOTED THAT, DURING THE REFILL, THE PUMP WAS EASILY ACCESSED, THE POCKET WAS EXAMINED AND NO SWELLING OCCURRED. IT WAS BELIEVED THAT THE PATIENT GOT A BOLUS OF DRUG. THE HEALTHCARE PROVIDER (HCP) INITIALLY BELIEVED THAT THE BOLUS LEAKED OUT OF THE PUMP RIGHT AFTER REFILL. HOWEVER, A WEEK LATER IT WAS REPORTED THAT THE POSSIBILITY OF A LEAK FROM THE SEPTUM WAS QUESTIONED BY THE NURSE, BUT THE HCP BELIEVED THAT THE BOLUS WAS DELIVERED TO THE INTRATHECAL SPACE. ON THAT DAY, THE PATIENT HAD AN APPOINTMENT WITH THE HCP, WAS DOING WELL AND BACK AT HER ORIGINAL DOSE. THERE WAS CONCERN REGARDING A REFILL SCHEDULED FOR (B)(6). IT WAS ALSO REPORTED THAT VOLUME DISCREPANCIES OCCURRED AT THE PATIENT'S THREE PREVIOUS REFILLS. IN (B)(6) 2012, THE EXPECTED RESIDUAL VOLUME (ERV) WAS 2.8ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 4ML. IN (B)(6) 2012, THE ERV WAS 2.8ML AND THE ARV WAS 4ML. ON (B)(6) 2013, THE ERV WAS 3.2ML AND THE ARV WAS 4ML. THE PATIENT EXPERIENCED DIZZINESS/LIGHT-HEADEDNESS IMMEDIATELY AFTER PAST REFILLS. THE DEVICE SYSTEM WAS USED TO DELIVER SUFENTA (SUFENTANIL) AND CLONIDINE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37902 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R