BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1081276 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04345
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    March 1, 2007
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED NAUSEA, VOMITING, AND A TINGLING SENSATION IN THE ABDOMEN WHEN THE STIMULATOR WAS TURNED ON FOR ABOUT THE PAST YEAR. AS A RESULT, THE PT HAD LOST 40 POUNDS SINCE EARLY 2008. WHEN STIMULATION WAS TURNED OFF, THE SYMPTOMS APPEARED TO GO AWAY AND THE PT WAS ABLE TO EAT. THE PT TRIED NUMEROUS MEDICATIONS AND UNDERWENT SEVERAL PROCEDURES, BUT ALL TESTS WERE NEGATIVE FOR ANY PROBLEMS OF A GASTROINTESTINAL ORIGIN. THE DEVICE WAS EVALUATED (APPROX THREE MONTHS LATER). IMPEDANCE WERE NORMAL FOR ALL BUT CONTACT 6 WHICH HAD IMPEDANCE >3600 IN ALL CONTACT PAIRS. LOW IMPEDANCE (<70) WAS ALSO NOTED ON ONE ELECTRODE PAIR (4 AND 5). REPROGRAMMING WAS ATTEMPTED TO CAPTURE STIMULATION OF HER PAINFUL AREAS WITHOUT ABDOMINAL STIMULATION, BUT WAS UNSUCCESSFUL. X-RAY WAS PERFORMED (SAME DAY) AND THE SYSTEM APPEARS TO BE INTACT WITH THE LEAD TIP AT THE LOWER END OF T7. THE PT WAS REFERRED TO THE NEUROSURGEON FOR FURTHER CONSULTATION. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXTENSION MODEL 37082 LOT# NKB001918N| LEAD MODEL 3998 LOT #L88279| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD031433N| ACCESSORY MODEL 37752 LOT# NKA023543N| EXPLANTED: