BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120204 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04064
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    July 24, 2025
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z#: 0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRUGS IN THE PUMP AT THE TIME OF THE EVENT WERE MORPHINE, BUPIVICAINE, AND BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 THAT THE PT EXPERIENCED OVERDOSE SYMPTOMS APPROXIMATELY 72 HOURS AFTER MORPHINE WAS ADDED TO THE PUMP. THE PT WAS SEEN IN THE ER. IT WAS LATER REPORTED THAT THE PT HAD BEEN ADMITTED TO THE HOSPITAL AND WAS STARTED ON A CONTINUOUS NARCAN DRIP. ON (B)(6) 2011, IT WAS REPORTED THAT WITHIN 7-8 HOURS AFTER A REFILL THAT HAD OCCURRED ON (B)(6) 2011, THE PT WAS HOSPITALIZED IN ICU AND INTUBATED. THE PT WAS HOSPITALIZED "OVER 7 DAYS" AND WAS JUST RELEASED FROM THE HOSPITAL "ABOUT 3-4 DAYS AGO." THE PT INDICATED THAT THE PUMP HAD FAILED AND CAUSED HIM TO GET OVERDOSED. AT THE TIME OF REFILL ON (B)(6) 2011, THE ACTUAL RESIDUAL VOLUME WAS 1CC AND THE EXPECTED RESIDUAL VOLUME WAS 11CC. THE MEDICATION WAS REMOVED FROM THE PUMP AND THE PUMP WAS FILLED WITH PRESERVATIVE FREE NORMAL SALINE. THE PT WAS ON ORAL BACLOFEN AND WAS CONCERNED THAT IT WAS "NOT GOOD FOR HIM." WHILE IN THE HOSPITAL, AN UNSPECIFIED TEST WAS PERFORMED AND IT WAS DETERMINED THAT THE PUMP "WAS RUNNING FASTER THAN PROGRAMMED." PER THE RPTR, THE PT HAD AN MRI BACK IN (B)(6) AND THERE WAS SOMEONE THERE TO CHECK THE PUMP; FURTHER DETAILS WERE NOT PROVIDED. IT WAS ALSO NOTED THAT "THIS PT HAS HAD THIS TYPE OF OCCURRENCE ON A COUPLE OF DIFFERENT OCCASIONS;" ONE OF WHICH HAD OCCURRED BACK IN (B)(6) 2010, WHERE TWO DAYS AFTER REFILL THE PT WAS ADMITTED TO THE HOSPITAL IN CRITICAL CONDITION. A PUMP REPLACEMENT WAS BEING PLANNED.

    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 NA Male Life Threatening| H| R CATHETER: MODEL 8709SC, LOT # N140563004| CATHETER: MODEL 8731, LOT # N001686233| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: | IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT # N001686233| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N140563004