BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200126 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-01094
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2008
    Report Date
    July 14, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007,PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED RELATED TO PUMP. HCP REPORTED PUMP ALARMING DUE TO A MOTOR STALL. STALL POSSIBLY DUE EMI DUE TO PATIENT SLEEPING IN A MAGNETIC BED. THERE HAD BEEN MULTIPLE MOTOR STALLS. HCP REPORTED THERE WAS ONE MOTOR STALL THE DAY OF THE REPORT ((B)(6) 2008), AT 6:30, THEN ONE (B)(6) 2008, AT 8:00 AM AND THEN AT 12:30 AM RECOVERY OCCURRED SHORTLY. LAST MOTOR STALL WAS ON THE (B)(6), TELEMETRY STRIPS PROVIDED INDICATED THE EARLIEST MOTOR STALL OCCURRED (B)(6) 2008 WITH RECOVERY. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299326 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR