BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3063524 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06438
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID: 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3389-40 LOT# J0230871V, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3389-40 LOT# J0230871V, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LEANING OVER DRASTICALLY TO THE RIGHT SIDE FOR ABOUT A WEEK OR SO. IT WAS STATED THAT OVER THE PAST TWO DAYS, THE PATIENT WAS FALLING MORE OFTEN, WAS STIFF AND HAVING DIFFICULTY MOVING. THE PATIENT TRIED TO TURN THE LEFT DEVICE ON AND WAS ONLY GETTING THE 9 VOLT BATTERY LIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165945 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1