BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1760501 · Received July 15, 2010

    Report

    Report Number
    3007566237-2010-05502
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PUMP WAS ALARMING. A MOTOR STALL WAS DETECTED. THE PT HAD NOT HAD AN "MRI, ETC. SINCE REFILL ON (B)(6)". THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER PRIALT AND MORPHINE SULFATE.

    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 43 YR Required Intervention CATHETER: MODEL 8731, LOT# UK6142972| IMPLANTED:| EXPLANTED: