BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3830618 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09584
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 5, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE ¿CALL YOU DOCTOR¿ ICON DISPLAYED. THE PATIENT TURNED HER INS OFF BEFORE GOING ON THE AIRPLANE TO (B)(6). THE TSA AGENT TOLD THE PATIENT TO GO THROUGH THE SECURITY MACHINE, SHE THINKS THAT ¿AFFECTED¿ HER INS. THE PATIENT TURNED HER INS ON AFTER ARRIVING IN (B)(6). LAST NIGHT THE PATIENT TRIED TO TURN HER INS DOWN BECAUSE IT WAS TOO HIGH, THE PATIENT PROGRAMMER (PP) WOULD NOT ALLOW HER TO. THE PATIENT SAW THE SYNCH PP TO INS SCREEN, SHE TRIED AND THEN SAW A PICTURE OF A DOCTOR. THEN THE PATIENT GOT HER RECHARGER AND WAS ABLE TO TURN HER INS OFF. THE PATIENT DID NOT REMEMBER WHAT THE CODE WAS WITH THE DOCTOR SCREEN. THE PATIENT TRIED TO REPLICATE IT, SHE GOT HER PP AND REPORTED IT WAS WORKING NOW. THE PATIENT RETURNS HOME TOMORROW. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308421 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 00054 YR