BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2775158 · Received October 7, 2012

    Report

    Report Number
    3004209178-2012-08958
    Event Type
    Malfunction
    Date Received
    October 7, 2012
    Report Date
    September 7, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SEVERAL CT SCANS AND WAS HOSPITALIZED IN (B)(6) BECAUSE OF A BOWEL OBSTRUCTION. A MONTH LATER THE PATIENT CAME TO THE OFFICE WITH A RETURN OF SYMPTOMS AND A POWER-ON-RESET CONDITION (POR) MESSAGE WAS SEEN ON THE PROGRAMMER. THE POR WAS CLEARED AND AN END-OF-LIFE MESSAGE WAS SEEN. IT WAS NOTED THAT THE LONGEVITY WAS APPROPRIATE AS THE PATIENT WAS AT HIGHER SETTINGS, AND THE PATIENT PLANNED TO GET A BATTERY REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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