BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924783 · Received December 7, 2010

    Report

    Report Number
    3007566237-2010-10272
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELT A BURNING SENSATION FOLLOWING A REFILL. DUE TO THIS, THE HCP ATTEMPTED TO ASPIRATE THE CONTENTS OF THE PUMP RESERVOIR BUT "GOT NOTHING BACK." PER THE REPORTER, A POCKET FILL OCCURRED. THE PT WAS ADMITTED TO THE HOSPITAL "AS A PRECAUTION." THE PUMP DELIVERED LIORESAL 2000 MCG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 24 YR Hospitalization EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# J11039R21| CATHETER: MODEL 8596, LOT# N001941521