BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2100653 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03484
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    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 CATHETER WAS UNABLE TO BE ASPIRATED. IT WAS ALSO REPORTED THAT THE PT EXPERIENCED SHORTNESS OF BREATH AND WEAKNESS AFTER A REFILL. THE PUMP RESERVOIR WAS ACCESSED AND THERE WAS NO VOLUME DISCREPANCY. ALL THE MEDICATION WAS IN THE PUMP AND THERE WAS NO POCKET FILL. THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM TO CHECK AND SEE IF THE PT HAD A CARDIAC EVENT. THE SYMPTOMS WERE DETERMINED TO NOT BE PUMP RELATED. THE DRUG 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 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N2625990006| EXPLANTED: