BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202728 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01104
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS REPLACED DUE TO END OF LIFE/END OF SERVICE (EOL/EOS). IT WAS STATED THAT THE EOL/EOS WAS WITHIN THE EXPECTED RANGE. THERE WERE NO THERAPY OR MEDICAL PROBLEMS REPORTED. IT WAS STATED THAT THE DATE ON THE PUMP LOGS (WHEN PRINTED OUT) APPEARED TO BE OFF, WHICH WAS DETERMINED TO BE DUE TO THE CLINICIAN PROGRAMMER (STATED EOS WAS 15-MAY-2097). THE PUMP WAS FOUND TO HAVE BEEN OFF FOR 100 HOURS AND 41 MINUTES. WHEN THE MANUFACTURER REPRESENTATIVE INTERROGATED THE DEVICE, THE CURRENT PUMP SETTINGS WERE SEEN AND IN THE EVENT LOG IT READ "EXAMINED AT (B)(6) 2012 AT 11:37." IT WAS UNCLEAR IF THE ISSUE WAS RELATED TO THE CLINICIAN PROGRAMMER OR THE SOFTWARE. DRUG : DILAUDID (PRIMARY), BACLOFEN, AND MARCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302972 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR