BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1052997 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-02820
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR HAD STOPPED INTERMITTENTLY TWO TIMES THAT MORNING; THE PATIENT WAS SUBSEQUENTLY UNABLE TO ADJUST STIMULATION THERAPY CONTROL. THERE WERE NO KNOWN SOURCES OF EMI AT HER RESIDENCE AND NO CHANGE TO DAILY ROUTINE WAS REPORTED. THE PATIENT WOULD VERIFY THAT STIMULATION THERAPY WAS TURNED ON, THEN CHECK DEVICE STATUS LATER AND FIND THE BATTERY HAD POWERED OFF. THERE WERE NO PT SYMPTOMS ATTRIBUTED TO THE EVENT AND ONLY ONE PULSE GENERATOR WAS IDENTIFIED WITH THE PRODUCT PROBLEM. THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THE HCP. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR EXPLANTED:| EXPLANTED:| LOT# NFW145080H| LEAD MODEL 3387| EXPLANTED:| EXTENSION MODEL 7482| LEAD MODEL 3387| EXPLANTED:| EXTENSION MODEL 7482| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426