BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3953614 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13444
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 21, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION STOPPED THREE TO FOUR DAYS PRIOR TO REPORT. PATIENT SERVICES HAD THE PATIENT CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) AND BY DOING THIS THE PATIENT TURNED THE STIMULATION ON, FELT STIMULATION AND OBSERVED THAT THE BATTERY WAS ¿ABOUT 20% FULL.¿ THE PATIENT NOTED THAT SHE SPOKE TO THE MANUFACTURER REPRESENTATIVE ON THE DATE OF REPORT AND WAS DIRECTED TO PATIENT SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430112 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 00047 YR