BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3821474 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09284
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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 ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THE PATIENT¿S ISSUES WERE DUE TO THEIR SCIATIC NERVE. IT WAS REPORTED THE PATIENT SAW THEIR HEALTHCARE PROVIDER AND WAS DOING BETTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SORE AT THE IMPLANT SITE, STARTING THREE WEEKS PRIOR TO CALL. IT WAS NOTED THE PATIENT WENT TO THE ER TWO WEEKS PRIOR TO CALL FOR SWOLLEN LEGS. IT WAS REPORTED THE PATIENT HAD HIGH BLOOD PRESSURE, BREATHING PROBLEMS, PAIN WITH GOING TO THE BATHROOM, AND DAMAGED SCIATICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299779 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 00045 YR Other