BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3915640 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12573
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J11189R52; PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD RESPIRATORY DISTRESS. IT WAS REPORTED, THE PUMP CONTAINED DILAUDID AND BUPIVACAINE. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT HAD "HYPOPNEA WITH POSTOPERATIVE ALTERED LEVEL OF CONSCIOUSNESS. THE PATIENT HAD A "SLOW EMERGENCE FROM OR (OPERATING ROOM) SEDATION". THE EVENT WAS REPORTEDLY RELATED TO THE IMPLANT PROCEDURE/ANESTHESIA. DIAGNOSTICS PERFORMED WERE EXAMINATION AND PALPATION. THE PATIENT WAS ADMITTED TO THE ICU FOR OBSERVATION AND THE EVENT WAS NOTED TO HAVE "RESOLVED WITHOUT SEQUELAE" THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393758 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization