BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2236200 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-06829
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    January 1, 2010
    Report Date
    August 1, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ACTUAL RESIDUAL VOLUME WAS LESS THAT THE EXPECTED RESIDUAL VOLUME: ARV: 0 ML, ERV: 1.3 ML. PT EXPERIENCED AN UNDERDOSE WITH SYMPTOMS OF NAUSEA AND VOMITING SINCE (B)(6) 2011. LOW RESERVOIR ALARM VOLUME WAS SET TO 1ML. IT WAS ALSO ADDED THAT AT THE LAST REFILL IN (B)(6) THE ERV WAS 0.7 ML, BUT THEY GOT AN ARV 0 ML. AT THE FIRST REFILL AFTER THE PUMP WAS IMPLANTED THE ERV WAS 5.1 ML, BUT THEY GOT AN ARV OF 6.2 ML. IT WAS LATER REPORTED THAT THE PT MISSED THE SCHEDULED PUMP REFILL APPOINTMENT FOR THREE DAYS. THE RESERVOIR WAS EMPTY UPON ASPIRATION. THE DRUG INFUSED WAS MORPHINE 1.3 MG/DAY. ON (B)(6) 2011, THE PUMP WAS REFILLED AND THE RESERVOIR VOLUME ALARM WAS CHANGED TO 3ML. PT ALSO HAD ELEVATED TEMP AND HORRIBLE TASTE IN MOUTH. PT WAS HOSPITALIZED BECAUSE OF THE EVENT AND RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R CATHETER: MODEL 8709SC, LOT# N245493013| IMPLANTED:| EXPLANTED: