BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2671652 · Received July 26, 2012

    Report

    Report Number
    3004209178-2012-06141
    Event Type
    Injury
    Date Received
    July 26, 2012
    Report Date
    June 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3387S-40, LOT# V241399, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6); EXTENSION MODEL 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6); PROGRAMMER MODEL 7438, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST CONSCIOUSNESS AND FELL. THE HCP BELIEVED THAT THE BLACKOUT WAS DUE TO LOW BLOOD PRESSURE AND DEHYDRATION CAUSED BY A HIGH DOSAGE OF MEDICATION. THE PATIENT CUT HIS HEAD DURING THE FALL, AND IT WAS REPORTED THAT THE CUT JUST DIDN'T GO AWAY, AND ONE DAY WHEN THE PATIENT TOOK HIS HAT OFF IT "COLLAPSED" AND THE LEAD WAS EXPOSED. THE HCP DECIDED TO REMOVE THE IMPLANT AND DURING THE PROCEDURE IT WAS NOTED THAT EVERYTHING WAS FILLED WITH PUSS. THE PATIENT WAS ON ANTIBIOTIC FOR 6 WEEKS. THE PATIENT WAS SCHEDULED TO RECEIVE A NEW IMPLANT ON AUGUST 1ST. 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 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention