BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3150393 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08730
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT AND PHYSICIAN DIDN¿T THINK THE PUMP WAS WORKING ANYMORE. IT WASN¿T HELPING WITH THE PATIENT¿S PAIN ANYMORE; INITIALLY IT HAD BEEN. THE PHYSICIAN TOLD THE PATIENT THAT HE DIDN¿T THINK THE CATHETER WAS WORKING ANYMORE. THERE HAD BEEN NO VOLUME DISCREPANCIES AND NO DIAGNOSTICS HAD BEEN PERFORMED ON THE SYSTEM. ON (B)(6) 2013, THEY DECREASED THE DOSE 20% AND THERE HAD BEEN NO DIFFERENCE IN THE PATIENT¿S PAIN LEVEL EITHER PRO OR CON. A FEW MONTHS PRIOR, THEY HAD INCREASED THE DOSE. RIGHT AFTER THAT, THE PATIENT HAD PROBLEMS WITH HER LEGS; SHE COULDN¿T STAND ON THEM. IT WAS THOUGHT TO BE FROM TOO MUCH MARCAINE, SO THEY HAD TO BACK IT OFF A LITTLE BIT. HER PAIN LEVEL WAS THE SAME; SHE JUST COULDN¿T STAND ON HER LEGS. IT WAS ALSO NOTED THAT GENERALLY THE PATIENT DIDN¿T EVEN KNOW THE PUMP WAS THERE, BUT EVERY ONCE IN A WHILE IF SHE LEANED UP AGAINST THE KITCHEN COUNTER IN JUST THE RIGHT WAY ¿IT LETS ME KNOW IT¿S THERE¿/IT HURT. THE PATIENT WASN¿T A SURGICAL CANDIDATE DUE TO DECREASED LUNG CAPACITY AND LUNG CANCER. THE PATIENT WAS CONSIDERING NOT HAVING THE PUMP REFILLED ANYMORE; SHE HAD ORAL MEDICATION SO DIDN¿T THINK SHE WOULD GO THROUGH WITHDRAWAL. THE PATIENT WAS ALSO CONSIDERING LOOKING FOR ANOTHER PHYSICIAN. THE PUMP WAS DELIVERING CLONIDINE, DILAUDID, AND MAR CAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT THE PUMP WAS TURNED OFF WELL OVER A YEAR AGO BECAUSE THE PATIENT WAS NOT GETTING THE RELIEF THE PATIENT NEEDED. THE HEALTHCARE PROVIDER FILLED THE PUMP UP WITH SALINE. THE PATIENT WAS ALSO SEEKING A CLOSER HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250705 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR