BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3820618 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09258
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, LOT# N121205, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿EXTRAORDINARY LENGTHS¿ TO PERFORM AN ¿EMERGENCY REFILL¿. AS A RESULT, MEDICATION INTERVENTION SPECIFICALLY A REFILL AT THE HOSPITAL WAS REQUIRED. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS REQUIRED. THE HOME HEALTH AGENCY FAILED TO RECEIVE OR ORDER THE MEDICATION FOR THIS PATIENT WHO HAD A LOW RESERVOIR ALARM (SET POINT 0.5ML) ON (B)(6) 2014. THE PATIENT WAS INSTRUCTED BY THE HEALTH CARE PROVIDER (HCP) TO GO TO THE LOCAL ER (EMERGENCY ROOM). FROM THERE, SHE WAS FLOWN BY HELICOPTER TO CHILDREN¿S ER WHERE SHE WAS SUCCESSFULLY REFILLED AND CONTINUED NOW TO RECEIVE ADEQUATE THERAPY. THERE WAS A DISCREPANCY AT THE REFILL; 3ML WAS FOUND WHEN ONLY 0.5ML WAS EXPECTED. THE HCP REPORTEDLY DIDN¿T HAVE A SENSE IF THIS WAS A ONE TIME OR PATTERN OR NORMAL OCCURRENCE. THE ¿LOW SET POINT¿ WAS CHANGED TO 3ML TO ALLOW FOR EARLIER REFILL PREDICTION AND MORE BUFFER. THE PATIENT WAS REPORTEDLY DOING FINE AS OF THE DATE OF THIS REPORT WITH NO SYMPTOMS OF WITHDRAWAL, OVERDOSE, ETC. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. THREE DAYS LATER, IT WAS REPORTED THE DEVICE MANUFACTURER REPRESENTATIVE LEARNED ON (B)(6) 2014 THAT A ¿LITTLE RESERVOIR ALARM¿ HAD NOT ACTUALLY OCCURRED. THE PATIENT NEVER HAD ANY SYMPTOMS OF WITHDRAWAL OR OVERDOSE OR ¿ANYTHING LIKE THAT¿. IT WAS ALSO REPORTED ¿TO¿ REMAINED ON A CONSISTENT DOSE ¿SAME AS EVER BEFORE¿ WITH THE EQUIVALENT THERAPEUTIC RELIEF. THE CAUSE OF THE DISCREPANCY HAD NOT BEEN DETERMINED ALTHOUGH IT WAS NOTED THE DEVICE MANUFACTURER REPRESENTATIVE SUSPECTED ¿IT IS A CONSISTENT VOLUME¿. THE REFILL MANAGEMENT HAD RECENTLY TRANSITIONED AND AS A RESULT THE RECORDS WERE NOT CLEAR. ¿THEY¿ WOULD CONTINUE TO OBSERVE THE PATIENT AND TRACK TO SEE IF ANY ISSUE NEEDED TO BE REPORTED IN THE FUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300238 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR