BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2843785 · Received November 23, 2012

    Report

    Report Number
    3004209178-2012-10708
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-33, LOT# VA02DN8, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-33, LOT# VA02DN8, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION IN THE DEVICE POCKET AND THE ENTIRE SYSTEM WAS EXPLANTED. IT WAS NOTED THAT CULTURES WAS OBTAINED AND THE DEVICE WOULD BE SENT BACK. IT WAS LATER REPORTED THAT THE SIGNS AND SYMPTOMS OF INFECTION INCLUDED SWELLING AND PAIN. IT WAS STATED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED, INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED, AND THE INFECTION WAS RESOLVED. IT WAS ALSO NOTED THAT THE CULTURE SOURCES WERE DEVICE POCKET AND LUMBAR REGION, BUT THE TYPE OF ORGANISM CULTURED WAS UNKNOWN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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 54 YR Required Intervention