BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2924761 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00811
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    November 30, 2012
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID: 3387-40 LOT# J0417811V, PRODUCT TYPE LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S RIGHT IMPLANTABLE NEUROSTIMULATOR HAD "SPONTANEOUSLY TURNED ITSELF OFF." THIS OCCURRED WHILE THE PATIENT WAS "REACHING OVER HIS LAPTOP TO PLUG A USB INTO THE PORT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED ¿ANXIETY WAS SETTING IN¿ FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29086 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1