BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2551360 · Received April 27, 2012

    Report

    Report Number
    3004209178-2012-02730
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Report Date
    April 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYP EXTENSION, PRODUCT ID 3387S-40, LOT# V014191, IMPLANTED: 2007 (B)(6), PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION WAS TURNING OFF ON ITS OWN DAILY. THE IMPEDANCES WERE MEASURED AND NO PROBLEMS WERE FOUND. THE DEVICE WAS INTERROGATED AND AT THE TIME IT WAS ON AND OPERATING WITHOUT ISSUES. THE REPORTER BELIEVED THE PATIENT SAW HER "MVD NL" ON (B)(6) 2012, BUT NO CONFIRMATION OF THE APPOINTMENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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