BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3173665 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10451
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN. PRODUCT TYPE: UNKNOWN: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RASH FROM THEIR TRUNK TO THEIR LEGS. IT WAS LATER REPORTED, THE PATIENT HAD DEVELOPED A RASH ALL OVER THEIR TRUNK, UPPER EXTREMITIES AND BUTTOCK AREA. IT WAS STATED THE RASH STARTED IN THEIR ARMS IN (B)(6) 2013 AND SPREAD FROM THERE. IT WAS NOTED THE PATIENT HAD ALLERGY TESTING DONE AND WAS FOUND TO BE ALLERGIC TO GOLD. IT WAS UNKNOWN IF THE PATIENT WAS TESTED FOR ANY MATERIALS FOUND IN THEIR SYSTEM. REPORTEDLY, THEY HAD TRIED CREAMS TO TREAT THE RASH. IT WAS LATER REPORTED THE PATIENT¿S RASH WAS LOCATED OVER THEIR IMPLANT AND THEIR SYMPTOMS OCCURRED AT THEIR IMPLANT LOCATION. IT WAS NOTED THE PATIENT WAS GOING TO BE TESTED FOR A TITANIUM ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274440 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 00063 YR Required Intervention