BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180262 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10646
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, LOT # L60852, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER, PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ABOUT TWO DAYS AFTER IMPLANT, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR RESPIRATORY FAILURE. IT WAS STATED THAT THE PUMP HAD BEEN PROGRAMMED AT A RATE 10% HIGHER THAN HER PREVIOUS DOSE. IT WAS THOUGHT THAT THE PATIENT HAD OVERDOSED, AS SHE HAD BEEN GIVEN MORE MEDICATION THAN WHAT WAS ORDERED FOR HER. WHILE IN THE HOSPITAL, THE HEALTHCARE PROFESSIONAL STOPPED THE PUMP. THE DEVICE SYSTEM WAS BEING USED TO DELIVER MORPHINE AND BACLOFEN. ON THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF A POST-OPERATIVE OVERDOSE. THE PATIENT HAD AN ¿ONSET OF PROBLEMS¿ THE DAY AFTER SURGERY AND HAD RETURNED TO THE HOSPITAL ON THE DAY AFTER THAT. IT WAS STATED THAT THE PATIENT WAS INTUBATED FOR HER RESPIRATORY DEPRESSION. ADDITIONALLY, THE PATIENT EXPERIENCED ALTERED MENTAL STATUS AND SEDATION. AT THE TIME OF REPORT, THE PATIENT¿S STATUS HAD IMPROVED WITH THE NEW DOSE OF INFUSION RESUMED, BUT WAS STILL INTUBATED. IT WAS STATED THAT THE LAST REFILL HAD BEEN DONE ON (B)(6) WITH A DOSE INCREASE FROM 6.961MG/DAY TO 7.665MG/DAY. FOLLOWING THE PUMP REPLACEMENT, THE DOSE HAD BEEN SET TO 7.647MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281280 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| L| O