BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201527 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01093
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED AS THEY ONLY HAD "A MONTH LEFT ON HER SYNCHROMED II." THE PATIENT HAD BACLOFEN IN THE PUMP. THE REPORTER "MADE SURE THAT THEY HAD AT LEAST ORAL BACLOFEN ON HAND." NO OTHER INFORMATION OR PATIENT IDENTIFIERS WERE PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303316 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization