BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230429 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06326
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HEADACHES. THE PT WAS SEEN BY A NURSE PRACTITIONER (NP) REGARDING A REFILL, AND IT WAS NOTICED THAT THE PT'S PUMP HAD MORE THEN EXPECTED LEFT IN THE PUMP. IT WAS FURTHER NOTED THAT "IT WAS NOT BIG ENOUGH DIFFERENCE TO WORRY". ON THE PT'S NEXT REFILL VISIT, THE DIFFERENCE IN CALCULATED DRUG LEFT IN THE PUMP VS. THE ACTUAL AMOUNT WAS "DRASTICALLY" DIFFERENT. DURING THE REFILL VISIT. THE PT SHOWED SHE COULD FLIP HER PUMP. SURGERY WAS SCHEDULED UNDER THE PREMISE THAT SOMETHING HAD HAPPENED TO THE CATHETER FROM THE PT FLIPPING THE PUMP. DURING SURGERY THE PHYSICIAN WENT INTO THE PUMP POCKET, AND DETERMINED THAT THE CATHETER WAS COMPLETELY TWISTED. AN OCCLUSION WAS FURTHER NOTED. THE PHYSICIAN CUT OFF THE PART OF THE CATHETER THAT WAS TWISTED; AND ADDED AN ADDITION CATHETER WITH A SPLICE KIT. THE CATHETER WAS THEN REATTACHED TO THE PUMP; AND A DYE STUDY WAS PERFORMED. A LARGE HOLE IN THE CATHETER, NEAR THE ANCHORING SITE, WAS FOUND. THE ENTIRE CATHETER WAS THEN REPLACED. IT WAS DECIDED TO REFILL THE PUMP WITH NEW DRUG BEFORE REATTACHING THE CATHETER, IN ORDER TO MAKE SURE THEY KNEW HOW MUCH DRUG WAS "IN THERE". WHEN THE NP WENT TO EMPTY THE PUMP, SHE ONLY GOT BACK 15 CC; AND THE CALCULATED/EXPECTED AMOUNT WAS 38CC. BECAUSE THIS WAS NOT THE FIRST TIME THE PUMP WAS FOUND TO CONTAIN AN UNEXPECTED AMOUNT OF DRUG, THE PHYSICIAN DECIDED TO NOT TAKE ANY CHANCES AND REPLACED THE PUMP. THE PT HAD RECOVERED WITHOUT SEQUELA. THE DRUG DELIVERED WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N269828014| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N283451011