BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1930059 · Received November 18, 2010

    Report

    Report Number
    3007566237-2010-09784
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MEMORY ERROR OCCURRED. THE PUMP WAS REINTERROGATED; IT WAS NOTED THAT THE PUMP WAS IN STOPPED PUMP MODE. THE PUMP LOGS WERE CHECKED. THE LAST LOG OF "PUMP RESTARTED DUE TO RESTART COMMAND" WAS ABSENT ON THE 3 UPDATES THAT WERE ATTEMPTED. THE HCP PLANNED TO UPDATE THE PUMP. THERE WERE SOURCES OF POTENTIAL EMI PRESENT; THE ERROR OCCURRED DURING A PUMP UPDATE OR INTERROGATION. NO THERAPY ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N182610006| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG018937N| EXPLANTED:| CATHETER: MODEL 8578, LOT# N266726001