BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983043 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00905
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A REFILL SESSION THE PT EXPERIENCED AN OVERDOSE WITH SEDATION. THE PT WAS GIVEN NARCAN AND RESPONDED. THE PT WAS BEING KEPT UNDER OBSERVATION. IT WAS NOTED THAT THE PT WAS FEELING WELL DURING THE REFILL AND HAD NO SYMPTOMS UNTIL AFTER THE REFILL WAS PERFORMED. THERE WERE NO ALARMS AND PROGRAMMING WAS CORRECT. PRIOR TO THE REFILL THE ACTUAL RESIDUAL VOLUME WAS 12 ML AND THE EXPECTED RESIDUAL VOLUME WAS 5.7 ML. THE HEALTHCARE PROFESSIONAL INDICATED THAT TYPICALLY THERE IS A 2 ML DISCREPANCY AT REFILLS. PER THE REPORTER, THE PUMP HAS FLIPPED MORE THAN ONCE; AT THE TIME OF THIS REPORT THE PUMP WAS NOT CURRENTLY FLIPPED. A REVISION WAS PLANNED. THE PUMP WAS USED TO DELIVER HYDROMORPHONE, CLONIDINE AND BUPIVICAINE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 61 YR Required Intervention CATHETER: MODEL 8731, LOT# N001281409| IMPLANTED:| EXPLANTED: