BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201531 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04783
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    February 1, 2012
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS IMPLANTED AT THE BEGINNING OF DECEMBER REPLACING A PUMP WITH A BATTERY THAT WAS ¿GOING DEAD¿. SHORTLY AFTER THE PUMP REPLACEMENT, THERE WAS A REPORTED LEAK POSSIBLY AT THE LUER LOCK OR AT THE CONNECTION SITE FROM THE PUMP TO THE TUBING, WHICH WAS REPAIRED SURGICALLY ON (B)(6). AFTERWARDS, THE PATIENT THOUGHT THE PUMP ¿WASN'T WORKING¿. THE PATIENT WENT BACK IN APPROXIMATELY TWO WEEKS LATER TO HAVE THE STITCHES TAKEN OUT AND WAS INFORMED THAT THE PUMP HAD BEEN ¿TURNED DOWN¿ FROM APPROXIMATELY 7.5 MG A DAY AT 30 MG CONCENTRATION TO APPROXIMATELY 3 MG. THE PATIENT FELT THIS WAS WHY HE WAS HAVING ¿ALL THE ISSUES¿. THE PUMP WAS THEN ¿TURNED BACK UP¿, AND THE PATIENT HAD BEEN ¿GOING BACK LIKE EVERY WEEK TO HAVE IT INCREASED¿. THE PATIENT HAD A PUMP REFILL ON THE DATE OF REPORT AND REQUESTED A PRINTOUT ¿OF THE PUMP FROM THE MACHINE, THE READER¿ BUT WAS NOT PROVIDED ONE. THE PATIENT WAS INFORMED THAT THEY HAD A PRINTER MALFUNCTION. THE PATIENT HAD SOME QUESTIONS ABOUT THE CONCENTRATION, DOSING AND WHEN THE LOW-LEVEL ALARM WAS GOING OFF. IT WAS REPORTED THAT THE WRONG CONCENTRATION HAD BEEN ORDERED, BUT ¿THEY WENT AHEAD AND STILL PUT THAT, THE LOWER CONCENTRATION IN¿ AND USED ¿SOME FORMULA FOR TRYING TO FIGURE OUT THE PAIN DOSING¿. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN ON THE SAME DOSAGE FOR THE ¿LAST AT LEAST THREE YEARS¿. THE PATIENT WAS DISTRESSED. 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
    301561 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention