BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6649786 · Received June 19, 2017

    Report

    Report Number
    3004209178-2017-13132
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    December 1, 2016
    Report Date
    February 9, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTHCARE PROFESSIONAL REGARDING A PATIENT RECEIVING BUPIVACAINE 5.0 MG/ML FOR A TOTAL DOSE OF 1.3241 MG/DAY AND DILAUDID (HYDROMORPHONE) 10.0 MG/ML FOR A TOTAL DOSE OF 2.648 MG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY, SPINAL CORD INJURY/SPINAL CORD DISEASE, AND NON-MALIGNANT PAIN. IT WAS REPORTED PATIENT HAD BEEN EXPERIENCING WITHDRAWAL LIKE SYMPTOMS FOR THE PAST COUPLE MONTHS AND PATIENT STATED "I'VE BEEN THROUGH THIS BEFORE WHEN THE PUMP RAN OUT OF MEDICATION." PATIENT NOTED CHILLS AND SWEATS CONSTANTLY. IT WAS NOTED PATIENT HAD THE PUMP CHECKED AND HAD JUST HAD A REFILL 2 DAYS AGO AND THE RIGHT AMOUNT OF MEDICATION CAME OUT. PATIENT STATED THIS HAPPENED "ABOUT 3 YEARS AGO WHERE PATIENT HAD WITHDRAWAL AND PUMP WENT EMPTY" AND HAPPENED 3 TIMES. IT WAS NOTED PATIENT CALLED EACH TIME. PATIENT ASKED IF IT WAS POSSIBLE THAT THE CATHETER COULD BE KINKED OR CRACKED. IT WAS REVIEWED THERE WAS NO WAY TO KNOW THIS AND PATIENT WOULD HAVE TO FOLLOW UP WITH HEALTHCARE PROFESSIONAL (HCP) TO CHECK THE CATHETER. PATIENT ASKED IF THE RIGHT AMOUNT OF MEDICATION COULD COME OUT STILL IF THERE WAS. IT WAS REVIEWED THE PUMP ONLY DETECTS WHAT IS IN THE PUMP AND IT DOES NOT SHOW WHERE THE MEDICATION IS DELIVERED. IT WAS STATED THAT THE HCP WOULD NOT CHECK BECAUSE HCP SAID THERE WAS NOTHING WRONG IF THE MEDICATION IS COMING OUT CORRECT. IT WAS STATED PATIENT KNOWS THIS CAN HAPPEN BECAUSE PATIENT'S HUSBAND WENT THROUGH THE SAME THING. PATIENT WAS REDIRECTED TO HCP TO DISCUSS MEDICAL CONCERNS. IT WAS LATER REPORTED PATIENT FIRST STARTED EXPERIENCING THE WITHDRAWAL, CHILLS, AND SWEATS IN (B)(6) 2016. IT WAS NOTED THAT WHEN ASKED TO CLARIFY THE WITHDRAWALS, SWEATS, AND CHILLS AS IF THERE WAS A THERAPY/PATIENT ISSUE, DEVICE ISSUE, PROCEDURE ISSUE, ETC. THE RESPONSE WAS "NO. PATIENT HAD EPISODES OF URINARY TRACT INFECTION (UTI) TREATED BY HEALTHCARE PROFESSIONAL, BUT STILL AFTER THEIR COMPLAINTS RETURNED." NO TROUBLESHOOTING WAS PERFORMED AND NO REFILL "DAY" AMOUNT. IT WAS NOTED THAT SYMPTOMS ARE ONGOING, BUT SYMPTOMS ARE DIMINISHED. THE CAUSE OF THE WITHDRAWAL, CHILLS, AND SWEATS WAS NOT CLEAR. IT WAS NOTED THAT THE HCP BELIEVED SO THAT THE WITHDRAWAL, CHILLS, AND SWEATS WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON) ON (B)(6) 2017. IT WAS REPORTED BY THE PATIENT THAT HER HEALTHCARE PROFESSIONAL (HCP) WOULD NOT ENTERTAIN DIAGNOSTIC STUDIES BECAUSE THE PATIENT WAS GETTING THE EXPECTED AMOUNT PULLED OUT OF HER PUMP WHEN REFILLS OCCUR. PATIENT STATED THE HCP HAD "AN ODD TREATMENT AND VIEW OF PAIN". PATIENT STATED THAT THE HCP FELT THE PATIENT HAD A VIRAL INFECTION AND PATIENT HAS BEEN ON HER SECOND ROUND OF ANTIBIOTICS AND DOESN'T FEEL THE SAME AS WHEN SHE EXPERIENCED WITHDRAWALS IN THE PAST. THE PATIENT HAS BEEN ON ANTIBIOTICS TWICE FOR A SUSPECTED BLADDER INFECTION AND SHE DOESN'T HAVE A BLADDER INFECTION. ON (B)(6) 2017 THE PATIENT STATED SHE JUST HER PUMP REFILLED TWO WEEKS AGO AND FELT SHE WAS GOING THROUGH WITHDRAWALS WITH SYMPTOMS OF CLAMMINESS, CHILLS, SWEATING, AND NOT GETTING THE SAME PAIN RELIEF. PATIENT STATED THAT THE HCP REDUCED THE AMOUNT OF MEDICATION WHEN REFILLED THE PUMP AND NEVER TOLD THE PATIENT WHY HE WAS DOING IT. THE PATIENT NOTICED THE CHANGE IN MEDICATION AMOUNT WHEN SHE LOOKED AT THE SHEET. SINCE THE REDUCTION, THE PATIENT HAD FELT BOTH HER HANDS AND FEET BURN FROM HER PREEXISTING PERIPHERAL NEUROPATHY AND DID NOT KNOW WHY THE HCP REDUCED THE MEDICATION. ***THERE WAS ADDITIONAL INFORMATION REPORTED THAT WAS NOT RELEVANT TO THIS EVENT AND THEREFORE WAS OMITTED; SEE PE (B)(4)-EMPTY BEFORE REFILL/WITHDRAWAL, PE (B)(4) WITHDRAWAL/EMPTY RESERVOIR, PE (B)(4)-ALARM/MISSED REFILL/WITHDRAWAL, AND PE (B)(4)-SPOUSE CATHETER ISSUE.*** 2017-06-14 LFC2 (HCP): ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT MISSED A REFILL APPOINTMENT AND WAS RESCHEDULED. PATIENT EXPERIENCED FEVER, PATIENTS SYMPTOMS RESTARTED, PUMP WAS REFILLED. PATIENT WAS ON ANTIBIOTIC. ONCE PUMP WAS REFILLED HER "CLINIC" IMPROVED BUT SLOWLY. THE PUMP MEDICATION RATE WAS INCREASED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430788 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR