BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190143 · Received June 26, 2013

    Report

    Report Number
    3007566237-2013-02109
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE ICU ON (B)(6) 2013 WITH AN ALTERED MENTAL STATUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PASSED AWAY ON 2013-(B)(6). IT WAS NOTED THAT THE PATIENT BEING ADMITTED TO THE ICU (AS PREVIOUSLY REPORTED) HAD NOTHING TO DO WITH THE PUMP, BUT INSTEAD THE PATIENT WAS ADMITTED DUE TO AN ALTERED STATE CAUSED BY UNCONTROLLED DIABETES. IT WAS NOTED THAT THE CAUSE OF DEATH WAS NOT DEVICE RELATED. IT WAS FURTHER NOTED THAT THE PUMP HAD BEEN DISPOSED OF. THE PUMP HAD BEEN DELIVERING DILAUDID 10MG/ML, 3.8MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290478 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization