BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2579777 · Received May 18, 2012

    Report

    Report Number
    3004209178-2012-03462
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    April 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 7482A40, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT# V101646, IMPLANTED: 2008 (B)(6), EXPLANTED: NA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEVERE CATATONIA RELATED TO A LACK OF THERAPY. THE SYSTEM HAD BEEN OFF. AFTER IT WAS TURNED BACK ON IN THE HOSPITAL, THE SYSTEM INTERFERED WITH EKG MONITORING. THE NEUROSTIMULATOR ALSO HAD HIGH IMPEDANCE READINGS, GREATER THAN 40000 OHMS ON ELECTRODE 2. THE PATIENT HAD NOT FALLEN OR HAD ANY INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE HIGH IMPEDANCE EVENT WAS RELATED TO THE PATIENT'S LEFT NEUROSTIMULATOR WHICH IS REPORTED IN MANUFACTURER REPORT # 3004209178-2012-03463.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention