BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901985 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09397
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS BEING GIVEN NARCAN DUE TO LOW BLOOD PRESSURE AND BREATHING ISSUES. IT WAS STATED, THE REPORTER BELIEVED, THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. THE REPORTER ALSO STATED, THE PATIENT HAD "A NUMBER OF UNDERLYING SYMPTOMS THAT COULD BE CAUSING" THE REPORTED SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANTED:| CATHETER: MODEL 8709, LOT #N085613011| CATHETER: MODEL 8598A, LOT #N146152008| IMPLANTED:| EXPLANTED:| EXPLANTED: