BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2750896 · Received September 19, 2012

    Report

    Report Number
    3004209178-2012-08254
    Event Type
    Injury
    Date Received
    September 19, 2012
    Report Date
    August 20, 2012
    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

    PRODUCT ID 3888-45, LOT # V821908, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V885492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PRODUCT ID 3708220, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT # V741665, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V931748, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PATIENT'S PERIPHERAL LEADS WAS INFECTED. THE DOCTOR REMOVED BOTH PERIPHERALS AND PUT BOOTS OVER THE EXTENSION. THE FACILITY DISPOSED OF THE LEAD. PATIENT WAS DOING WELL AND WAS GETTING GOOD EPIDURAL STIMULATION BEFORE AND AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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