BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3133835 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08235
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 8, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ¿UNABLE TO GET ANY COUPLING BARS¿ AND EXPERIENCED ¿A COUPLING PROBLEM.¿ IT WAS NOTED THE PATIENT WAS ABLE TO ¿TURN ON AND OFF WITH THE PATIENT PROGRAMMER.¿ IT WAS ADDITIONALLY NOTED THE PATIENT ¿DID NOT HAVE ANY ISSUES WITH COUPLING A FEW DAYS¿ PRIOR TO REPORT. ADDITIONAL INFORMATION STATED THE PATIENT WAS ¿NO LONGER¿ ABLE TO COUPLE THEIR BATTERY AND CHARGER. ADDITIONAL INFORMATION STATED THE PATIENT'S BATTERY WAS FOUND TO HAVE BEEN "FLIPPED IN THE POCKET" DURING A FOLLOW-UP APPOINTMENT. THE PATIENT HAD A REVISION PERFORMED (B)(6) 2013. IT WAS NOTED THE "INTEGRITY OF THE SYSTEM WAS INTACT AND THAT THE "BATTERY WAS POSITIONED CORRECTLY AND THE PATIENT WAS DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235067 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 Required Intervention