BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORESENSOR MRI

    MDR report key: 4862002 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12032
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 4, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE (B)(6) PATIENT EXPERIENCED AN OVERHEATING AND BURNING SENSATION ¿IN THE SKIN AREA AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS).¿ THIS WAS REPORTED TO HAVE OCCURRED AFTER ABOUT TEN MINUTES OF RECHARGING THE INS. IMPEDANCE TESTING AND REPROGRAMMING WAS PERFORMED, HOWEVER THE RESULTS WERE NOT REPORTED. THE PATIENT¿S INS WAS REPLACED AT THE TIME OF REPORT AS A RESULT OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406855 RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention