BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3971777 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13792
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FEELING THE STIMULATOR STOP AND START AND THEY WERE FEELING A ¿MODULATION SENSATION¿. IT WAS NOTED THAT THIS ISSUE WAS MAKING THE PATIENT FEEL NAUSEOUS AND DIZZY. THE EVENT BEGAN ON (B)(6) 2014 AND THE SYMPTOMS GRADUALLY STARTED. THE STIMULATOR WAS FULLY CHARGED AND THE STIMULATION WAS TURNED ON, THE PATIENT HAS NOT HAD ANY FALLS OR TRAUMAS AND HAD NOT HAD ANY EXPOSURE TO STRONG ELECTRONICS OR MAGNETS. THE PATIENT NOTED INCREASING THEIR STIMULATION ON (B)(6) 2014 AND IT DID NOT CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448603 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 00068 YR