BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1892723 · Received October 28, 2010

    Report

    Report Number
    3007566237-2010-08588
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    IT WAS REPORTED THAT THERE WAS AN INFECTIONS WITH "SERRATIA. PT WAS IMPLANTED APPROX 2 MONTHS PRIOR. PT STARTED TO GET FLUID IN THE POCKET, THE DOCTOR PRESCRIBED ANTIBIOTICS, AND INFECTION STARTED TO TRACT EXTENSION AND LEAD. ALL COMPONENTS REMOVED APPROX 2 WEEKS PRIOR, CUT LEAD AT BURR HOLE. THE COMPANY REP ATTENDED BOTH STAGE 1 AND 2 AND NOTHING OUT OF THE ORDINARY OCCURRED. ADDITIONAL INFO 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 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# UNK| IMPLANTED: