BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1910978 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09872
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED TWO EPISODES OF MORPHINE WITHDRAWAL OVER THE LAST TWO WEEKS; SYMPTOMS INCLUDED CHILLS, DIARRHEA, AND MUSTY SMELLS. THE PT WAS ADMITTED TO THE HOSPITAL BOTH TIMES. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization CATHETER: MODEL 8703W, LOT# L78428| IMPLANTED:| EXPLANTED: