BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3894403 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12031
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 2, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# LB5432, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A STINGING IN THE POCKET ¿A COUPLE MONTHS¿ AGO. THIS OCCURRED ONE TIME A DAY, SOMETIMES TWICE A DAY LIKE TODAY. THE PATIENT WOULD TYPICALLY REACH BACK AND PRESS ON THE INS AND IT WOULD STOP. IT WAS NOT RELATED TO POSITIONAL MOVEMENT AS IT VARIED. THE EPISODES WERE LASTING LONGER IN DURATION. ALL IMPEDANCES WERE REPORTED TO BE GOOD EXCEPT 0/3 = <(><<)>50OHMS WHICH WERE NOT BEING USED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS INFORMED TO KEEP A LOG REGARDING INSTANCES OF STINGING: TIME, DURATION, LOCATION, BODY POSITION, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371480 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 00044 YR