BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3102651 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07440
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS ¿NOTICED¿ FOUR DAYS PRIOR TO THE INITIAL REPORT. THE PATIENT WAS DUE FOR A REFILL ¿ALMOST A MONTH¿ BEFORE THE INITIAL REPORT WAS MADE. THE PATIENT WAS LOOKING FOR A PUMP PROVIDER CLOSER TO HER HOME; SHE DID HAVE A REFERRAL TO ONE BUT DUE TO DISTANCE WAS NOT ABLE TO FOLLOW UP WITH HIM. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY SYMPTOMS ¿IN THE SPASTICITY AREA,¿ BUT THAT SHE HAD BEEN ¿TRYING TO FIGURE OUT A SEVERE CASE OF PNEUMONIA.¿ THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN. IT WAS LATER REPORTED, THREE DAYS AFTER THE INITIAL REPORT, THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PNEUMONIA WHICH WAS NOT DEVICE OR THERAPY RELATED. THE PATIENT WAS WORRIED ABOUT RUNNING OUT OF MEDICATION BECAUSE OF HER DISTANCE TO A PROVIDER WHO WOULD FILL THE DEVICE AND WAS CONCERNED ¿THERE WAS NO WAY TO GET THE PUMP FILLED.¿ THE PATIENT DID HAVE THE LAST PRINT OUT WHICH WAS FROM THREE DAYS PRIOR, AND ACCORDING TO WHAT THE PATIENT RELAYED ABOUT THE PRINT OUT, THERE SHOULD HAVE BEEN 16 DAYS LEFT BEFORE THE PUMP REACHED EMPTY. THE PATIENT DID NOT COMMUNICATE TO THE REPORTER ABOUT AN AUDIBLE ALARM, AS WAS PREVIOUSLY REPORTED BY THE PATIENT. THE PATIENT HAD INDICATED TO THE REPORTER THAT SHE WAS ¿NOT EXPECTING¿ TO BE IN THE HOSPITAL FOR ¿LONG.¿ THE PATIENT INDICATED THAT SHE WOULD CALL IF SHE WAS GOING TO BE IN THE HOSPITAL FOR LONGER SO SHE COULD MAKE ARRANGEMENTS FOR SOMEONE FILLING HER PUMP. IT WAS NOTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE LIORESAL 500 MCG/ML AT 124.89 MCG/DAY. IT WAS LATER ADDED, SIX DAYS AFTER THE INITIAL REPORT WAS MADE, THAT THE PREVIOUSLY REPORTED DRUG DETAIL WAS INCORRECT, THE CORRECT DRUG INFORMATION WAS LIORESAL 2000MCG/ML AND THE DAILY DOSE WAS 132MCG/DAY. IT WAS ALSO NOTED THAT THOUGH THE REFILL DATE HAD PASSED THERE WAS STILL 48 DAYS OF DRUG LEFT IN THE PUMP. ALTHOUGH THERE WAS DRUG IN THE PUMP, IT WAS PAST THE RECOMMENDED SHELF LIFE FOR DRUG TO BE IN THE PUMP, THUS EXPIRED. THE PATIENT WAS STILL HOSPITALIZED AND WOULD REMAIN SO ¿FOR A WHILE.¿ THE PATIENT DID FIND AN HCP IN THE HOSPITAL WHO WOULD PERFORM THE REFILL, HOWEVER HE REQUIRED A REFERRAL FROM THE ATTENDING PHYSICIAN CARING FOR THE PATIENT UP UNTIL HOSPITALIZATION. IT WAS NOTED THAT THE HCP WAS ¿HAVING ISSUES WITH THE PHARMACIST¿ OF THE HOSPITAL WHO DID NOT WANT TO ORDER LIORSEAL AND THE REQUEST FOR MEDICATION AND NEED FOR REFILL WAS ONGOING. IT WAS NOTED THAT THE PATIENT WAS NOT IN IMMEDIATE DANGER OF WITHDRAWAL AND THE PATIENT WAS NOT EXPERIENCING ANY WITHDRAWAL SYMPTOMS. ACCORDING TO THE PATIENT¿S FAMILY THE PT WAS DOING ¿VERY WELL.¿ IT WAS AGAIN NOTED THAT THE HOSPITALIZATION AND OTHER PROCEDURES WERE NOT RELATED TO THE DEVICE OR THERAPY. THERE WAS TO BE FURTHER COMMUNICATION FOLLOWING THE REFILL AND FINAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202734 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1