BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3133077 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08277
    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
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 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 PRIOR TO IMPLANT THE PATIENT COULD WALK BUT AFTER SURGERY HE COULD NOT WALK. THE PATIENT¿S RIGHT LEG WAS ¿DEAD, NO FEELING, WEAK, AND FOOT DROOPED.¿ IT WAS NOTED THE PATIENT HAD HAVING TROUBLE WITH BOTH LEGS BUT THE RIGHT LEG WAS WORSE. IT WAS ALSO NOTED THE PATIENT HAD KNEE SURGERY 7 YEARS AGO. THE PATIENT WAS HAVING PHYSICAL THERAPY FOR HIS LEGS AND WANTED TO USE PERCUTANEOUS ELECTRICAL NERVE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234178 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 00061 YR Disability