BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3976838 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13902
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V240350, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS IN A HOSPITAL IN (B)(6) 2013, A WHEELCHAIR ALARM TURNED OFF HIS IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT MAY HAVE GONE A NIGHT WITH STIMULATION OFF AND THE NEXT DAY HIS DAUGHTER NOTICED AND CHECKED THE INS WITH THE PROGRAMMER. THEY TURNED STIMULATION BACK ON AND THIS RESOLVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453687 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1