BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093641 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03465
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS "FEELING DRUG EVEN AT LOWEST CONCENTRATION AT MINIMUM RATE". THE HCP PLANNED TO STOP THE PUMP AND REMOVE THE PUMP. IT WAS LATER REPORTED THAT THE EVENT WAS NOT ATTRIBUTED TO DEVICES. PUMP WAS PLACED IN SHUT OFF MODE. THE PT HAD BEEN RECEIVING MORPHINE 5 MG/ML - MINIMAL RATE. PER THE HCP, THE PT EXPERIENCED AN "ADVERSE REACTION TO MED" WITH SOMNOLENCE; CARDIOVASCULAR PROBLEMS; NAUSEA; RESPIRATORY PROBLEMS AND VOMITING. THE MFR'S DEVICE REGISTRATION SYSTEM INDICATED THAT THE DEVICE WAS REMOVED. THE PT RECOVERED WITHOUT SEQUELA.

    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 Required Intervention CATHETER: MODEL 8709SC, LOT# N231142013| EXPLANTED:| IMPLANTED: