BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872608 · Received October 12, 2010

    Report

    Report Number
    3007566237-2010-07851
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED, A CONFIRMED MOTOR STALL WITH SUBSEQUENT RECOVERY. PER HCP, THE MOTOR STALL WAS "CAUSED BY PT HAVING MRI JUNE 30TH." THERE WERE NO REPORTS OF AN AUDIBLE ALARM OR RETURN OF SYMPTOMS. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR EXPLANTED:| CATHETER: MODEL 8703W, LOT# L51797| IMPLANTED: