BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1844557 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07250
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    March 1, 2008
    Report Date
    August 13, 2010
    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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT'S PUMP "MALFUNCTIONED AND TOTALLY STOPPED WORKING." AS A RESULT, THE PT STATED, SHE "WENT INTO SEVERE WITHDRAWAL." THE PT STATED, SHE WAS "CONSTANTLY SICK" AND HAD VOMITING AND DIARRHEA. THE PT WAS HOSPITALIZED FROM (B)(6) TO (B)(6) AND LOST (B)(6) DURING THAT PERIOD. THE PT'S PUMP WAS REPLACED, AND THE NEW PUMP IS "WORKING FINE." THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. A FOLLOW-UP REPORT WILL BE SENT 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 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N150957004| EXPLANTED: