BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1761196 · Received July 15, 2010

    Report

    Report Number
    3004209178-2010-05503
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THERE HAD BEEN SEVERAL MOTOR STALLS AND RECOVERIES THAT HAVE OCCURRED. 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 PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N121697015| EXPLANTED: