BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2832870 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10280
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED BECAUSE "IT WAS UNCOMFORTABLE AND DID NOT CHARGE CORRECTLY." IT WAS NOTED THAT THE DEVICE WAS LOCATED IN HER BACK. IT WAS NOTED THAT THE DEVICE DID NOT "WORK PROPERLY." IT WAS NOTED THAT THE PATIENT'S DEVICE WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention