BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2973619 · Received February 22, 2013

    Report

    Report Number
    3007566237-2013-00567
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTS (VIA SOCIAL MEDIA) MY PUMP FAILED AND THE PUMP RECORDS DID NOT SHOW THE FAILURES; THE ALARMS ON THE PUMP NEVER SOUNDED. THE COMPLAINT CAME IN VIA SOCIAL MEDIA; NO FOLLOW-UP IS POSSIBLE AT THIS TIME DUE TO LACK OF CONTACT INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78654 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1