BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201713 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00358
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    February 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THIS FILE WAS REPORTABLE. IT WAS REPORTED THAT THE PUMP DISPLAYED AN ERROR DURING UPDATE AND THE PUMP WENT TO ¿STOPPED PUMP.¿ IT OCCURRED DURING INTEGRATION. AFTER REPROGRAMMED THE PUMP WAS UPDATED SUCCESSFULLY. THE PATIENT WAS UNKNOWN, AND THERE WAS NOT SYMPTOMS REPORTED. THE HEALTH CARE PROVIDER INDICATED THAT THE PUMP WAS RUNNING WHEN THE PATIENT LEFT. THE DRUG WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302401 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1