BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1870463 · Received October 11, 2010

    Report

    Report Number
    3007566237-2010-07802
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL. THE MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERED RECORDED. THE MOTOR STALL OCCURRED AFTER AN MRI FROM THE PREVIOUS DAY. THE PATIENT HAD SOME RETURN OF SPASTICITY AND WAS BEING MANAGED WITH ORAL BACLOFEN. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 40 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8731SC, LOT # N171917005| IMPLANTED: