BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1070190 · Received July 3, 2008

    Report

    Report Number
    2182207-2008-03718
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 7, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HEARD AN ALARM THAT HAD NOT BEEN CONFIRMED BY TELEMETRY. NO SYMPTOMS HAVE BEEN EXPERIENCED BY THE PT, ALTHOUGH, HE REPORTS TAKING PAIN MEDICATIONS. THE PUMP LOGS REVEALED TEN MOTOR STALLS SINCE 2008, WHICH LASTED ONLY SEVERAL MINUTES TO AN HOUR, ON MOST OCCURRENCES, THE PT HAS NOT HAD MRI'S OR HAS NOT BEEN AROUND ANY MAGNETIC FIELDS. THE PT NOTED THAT THIS WAS HIS THIRD PUMP AND THAT HE HAS HAD EXCELLENT PAIN RELIEF. REPLACEMENT SURGERY WAS BEING CONSIDERED. THE PT ALSO REPORTED ON-GOING INSURANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PROGRAMMER: MODEL 8840| CATHETER: MODEL 8703W| EXPLANTED: