BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSYNCHROMED II

    MDR report key: 2193380 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05410
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN UNDERDOSE. NO ALARMS WERE SOUNDING. THERE WAS A VOLUME DISCREPANCY, THE ACTUAL RESIDUAL VOLUME IS LESS THAN THE EXPECTED RESIDUAL VOLUME. THE EXPECTED VOLUME WAS 8 ML AND 0 ML WERE ASPIRATED. A DYE STUDY WAS SCHEDULED. IT WAS LATER THAT THE PT'S SYMPTOM WAS WITHDRAWAL. A ROLLER STUDY AND DYE STUDY WERE PERFORMED, BOTH WERE FINE. IT WAS NOT KNOWN HOW THE PT WAS FOLLOWING THE EVENT. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N143953022| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC , LOT# N117120009| EXPLANTED: