BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3222460 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11649
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 25, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON PATIENT REPORTED "AT THE TOP OF MY SHOULDER BLADES WHERE THE ELECTRODES ARE... IT BURNS. IT'S LIKE THE DEVICE IS SHOCKING ME OR BURNING ME." IT WAS ALSO REPORTED THAT PATIENT COULD FEEL THE ¿PULSING¿ IN THE RIBS AND FRONT. IT WAS INDICATED THAT PATIENT TRIED TURNING IMPLANTABLE NEUROSTIMULATOR (INS) DOWN AND COULD NOT FEEL IT IN THE RIBS BUT¿ WAS NOT HELPING AT THAT POINT¿. IT WAS STATED THAT THE PATIENT WAS NOT HAVING A GOOD DAY AND NOT A GOOD BACK DAY "EVEN WITH THIS THING ON¿. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324455 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 00053 YR