BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4524718 · Received February 18, 2015

    Report

    Report Number
    3004209178-2015-03221
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    November 13, 2014
    Report Date
    January 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S PUMP DIDN¿T SEEM TO BE WORKING; THE PATIENT WAS IN MORE PAIN SINCE SHE¿D HAD THE CURRENT PUMP IMPLANTED. SHE WAS IN MORE PAIN THAT SHE EVER HAD BEEN BEFORE. AFTER THE FIRST PUMP WAS IMPLANTED, THE FIRST DAY SHE WOKE UP AND FELT 75% BETTER; ¿THEY HAD TO INCREASE IT A COUPLE OF TIMES, BUT IT WAS LIKE HAVING A NEW LIFE¿. THE CURRENT PUMP WAS IMPLANTED ON A DIFFERENT SIDE THAN HER FIRST PUMP. THE PATIENT COULDN¿T UNDERSTAND WHY IT WAS WORKING THIS WAY. THEY ¿TOOK MY MEDICINE AND CUT IT DOWN AND PUT ME ON ORAL¿. THE PATIENT HAD WORSE MUSCLE SPASMS. THE PATIENT HAD HAD ¿A MAJOR FALL¿ WHICH SHE TOLD HER HCP (HEALTHCARE PROFESSIONAL) ABOUT. DURING THE FALL, ¿HER BACK AND FRONT ON THE STOMACH (WHERE THE PUMP WAS) WAS BEATEN REPEATEDLY WHILE SHE WAS PULLED DOWN A HILL ON ROCKS AND TREES¿. THE PATIENT¿S MANAGING HCP DIDN¿T THINK THAT THE CATHETER COULD HAVE MOVED, BUT EVER SINCE THE FALL, IT HAD GOTTEN WORSE. THE FALL WAS APPROXIMATELY TWO WEEKS AFTER IMPLANT. THE PATIENT THOUGHT THAT THE CURRENT PUMP WAS LYING ON HER MUSCLES AND THE FALL MADE IT WORSE. THE HCP KEPT INCREASING THE DOSAGE UNTIL THE PATIENT ¿COMPLAINED AND THEN HE CUT IT DOWN AND NOW HE HAD HER ON ALL THESE OTHER MEDS.¿ THE PATIENT HAD ISSUES WITH CERTAIN PAIN MEDS ¿IF THEY ARE HIGHER THEY MAKE ME WORSE, BUT I STILL HAVE THE CRAMPING AND THAT; NOTHING WAS EVER DONE AND NOW I¿M GOING THROUGH WITHDRAWALS FROM ALL THE DRUGS, BUT HE PRESCRIBED ME 3 MORE THAT I¿M CONCERNED WITH OTHER MEDICATION THAT I¿M ON THERE¿S GOING TO BE AN INTERACTION.¿ WHEN ASKED WHEN THE WITHDRAWALS STARTED, THE PATIENT STATED ¿THIS WAS YESTERDAY BECAUSE OF I DIDN¿T GET MY REFILLS AND I¿M NOT GONNA START THEM ¿TIL MONDAY BECAUSE I DON¿T; I¿M BY MYSELF OTHERWISE AND I HAVE 2 DOGS AND I WANT TO MAKE SURE HOW THEY MAKE ME FEEL AND SO FRIDAY NIGHT I WILL TAKE MY MEDS." THE PATIENT WAS HAVING AN MRI DONE TO CHECK FOR PROBLEMS WITH THE PUMP. THE PUMP WAS DELIVERING MORPHINE AND ANOTHER DRUG; THE PATIENT DIDN¿T KNOW THE NAME OF THE OTHER DRUG. THE PATIENT HAD HAD THE SAME DRUGS IN THE PUMP SINCE IMPLANT. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE EVENT WAS ATTRIBUTED TO THE PUMP. THE CAUSE OF THE EVENT WAS REPORTED BUT WAS ILLEGIBLE. THE HCP ANSWERED "6 WEEKS" TO THE QUESTION, "HOW LONG WAS THE PUMP STALLED FOR?". IT WAS UNKNOWN IF THE EVENT WAS DUE TO THE CATHETER. THE EVENT WAS NOT DUE TO PROGRAMMING. THERE WERE NO TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS TAKEN TO MITIGATE OR RESOLVE THE EVENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS INFECTION. THE EVENT WAS ATTRIBUTED TO THE PUMP. THE PUMP HAD NOT STALLED. THE PATIENT HAD A DOG SCRATCH AND FELL IN SNOW. THE EVENT WAS NOT DUE TO PROGRAMMING. THERE WERE NO TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS TAKEN TO MITIGATE OR RESOLVE THE EVENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116042 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Other