BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 796185 · Received December 7, 2006

    Report

    Report Number
    3004209178-2006-02162
    Event Type
    Malfunction
    Date Received
    December 7, 2006
    Date of Event
    November 1, 2006
    Report Date
    November 8, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    MHY
    PMA / PMN Number
    p960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS A PATIENT EXPERIENCING INTERMITTENT ON/OFF OF THEIR DBS DEVICE SINCE REPLACING THE RIGHT SIDE IN 2006. THE PATIENT HAS A DEVICE IMPLANTED IN BOTH THE RIGHT AND LEFT CHEST WALL. THE LEFT DEVICE WAS IMPLANTED IN 2004 AND THE RIGHT DEVICE WAS IMPLANTED IN 2006. STARTING IN NOVEMBER 2006, THE PATIENT REPORTED BOTH DEVICES TURNING ON AND OFF INTERMITTENTLY. THE PATIENT WAS SEEN IN THE CLINIC FOR TROUBLESHOOTING. A DIARY WAS KEPT TO LOG WHEN AND WHERE THE DEVICES WERE TURNING ON/OFF. CHANGES IN EMI EXPOSURE WERE REVIEWED WITH NO RECENT EMI EXPOSURE RECALLED. THE PATIENT HAS BEEN REFERRED TO ANOTHER PHYSICIAN FOR "INTERVENTION." THERE HAVE BEEN NO PATIENT SYMPTOMS OR INJURIES REPORTED AND THE PATIENT HAS NOT HAD ANY FALLS OR RECENT MEDICAL PROCEDURES. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED. SEE MFT REPORT #6000032200602163.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LEAD MODEL 3387, LOT# L49624, IMPLANTED| LEAD MODEL 3387, LOT# J0340648V, IMPLANTED| EXPLANTED| EXTENSION MODEL 7482, LOT# NHU016629V, IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 7495-51, LOT# XR0046374N, IMPL| EXPLANTED