BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 921630 · Received September 21, 2007

    Report

    Report Number
    6000030-2007-02855
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Report Date
    January 27, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS INVOLVING CATHETERS AND EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH, AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 19 PREVIOUSLY UNREPORTED MALFUNCTION EVENTS FOR THE SYNCHROMED PUMP; 10 UNREPORTED MALFUNCTION EVENTS FOR MODEL 8627L18, 3 MALFUNCTION EVENTS FOR MODEL 862718, 2 MALFUNCTION EVENTS FOR MODEL 863720, 2 MALFUNCTION EVENTS FOR MODEL 863740, 1 MALFUNCTION EVENT FOR MODEL 8626L18, AND 1 MALFUNCTION EVENT FOR MODEL 862710 FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    ON JANUARY 27, 2005,THE PATIENT REPORTED TO THE MANUFACTURER THAT ALL THE MEDICATION WAS STILL IN THE PUMP AT THEIR OFFICE VISIT. THE PATIENT CALLED AGAIN TO REPORT LEFT-SIDED NUMBNESS FROM THE STOMACH DOWN WHICH STARTED IN 2004. THE PATIENT WAS HOSPITALIZED AFTER A FALL (IN 2004) ATTRIBUTED TO NUMBNESS. THEN THE NEXT MONTH, THE PATIENT WENT TO THE ER BECAUSE THEY FELT A SURGING SENSATION AT THE PUMP SITE (LOWER RIGHT ABDOMEN) AND BOTH SIDES WERE NUMB FROM THE STOMACH DOWN; IT WAS TINGLY AND THE PATIENT COULDN'T MOVE THEIR LEGS. FIFTEEN DAYS LATER, THE PATIENT WENT TO HAVE THE PUMP REFILLED AND THEY FOUND A LOT OF THE MEDICATION STILL IN THE PUMP FROM THE MONTH PRIOR TO REFILL. THE NEXT REFILL WAS IN 2005 AND ALL OF THE MEDICATION WAS STILL IN THE PUMP. THE DECISION WAS MADE TO REPLACE THE PUMP, WHICH WAS SCHEDULED FOR THE NEXT MONTH. THE PATIENT REPORTED THEY WERE GETTING HEADACHES THAT START IN THE BACK OF THE NECK. THE PATIENT DID CALL THEIR HCP ABOUT THE HEADACHES; HOWEVER, HE HAS NOT CALLED BACK YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CATHETER MODEL 8709 LOT #L54314 | EXPLANTED: | IMPLANTED: | IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709 LOT #L54314