BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5778925 · Received July 8, 2016

    Report

    Report Number
    3004209178-2016-13800
    Event Type
    Injury
    Date Received
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE BATTERY PACK AND LEADS WERE REMOVED SECONDARY TO BATTERY MALFUNCTION AND REFRACTORY PAIN SYNDROME. THE MANUFACTURER REPRESENTATIVE HAD TRIED SEVERAL PROGRAMS AND ALL SEEMED LIKE THE PATIENT¿S BODY WAS ALREADY USED TO THEM. TURNING UP THE ¿RATE OR GAIN¿ ON THE LEADS SEEMED TO HAVE CAUSED ABDOMINAL DISCOMFORT AND GAVE NO COVERAGE TO THE MOST PAINFUL AREA ON THE LEFT SIDE HIP REGION. IT DID PROVIDE OPTIMAL DISTRACTION AND COVERAGE TO THE LEFT THIGH, CALF, AND DORSUM. THE BATTERY PACK AREA WAS UNCOMFORTABLE AND WAS STARTING TO GIVE OFF ¿A FREQUENCY OF ERROR MESSAGES¿ AND WAS NOT CHARGING AT ALL. THE PATIENT¿S ¿ORTHOPEDIC¿ EXPRESSED INTEREST IN PERFORMING AN MRI. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INDICATED FOR SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433470 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention