BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2082980 · Received May 4, 2011

    Report

    Report Number
    3007566237-2011-03224
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THERE WERE MOTOR STALLS NOTED ON (B)(6) 2011 AND (B)(6) 2011. THE PUMP CONTAINED MORPHINE 30 MG/ML. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    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 57 YR Female Required Intervention CATHETER: MODEL 8709, LOT# J12255R21.| EXPLANTED.| IMPLANTED.| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12255R21| IMPLANTED: