BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2760264 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08531
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 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 7496-66, SERIAL# (B)(4), IMPLANTED: 1994 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2001 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3986, SERIAL# (B)(4), IMPLANTED: 1994 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 3587A, LOT# L85959, IMPLANTED: 2001 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION. THE INFECTION BEGAN FOLLOWING AN IMPLANT OF TWO IMPLANTABLE NEUROSTIMULATORS (INS) ON (B)(6) 2012. BOTH INS'S WERE EXPLANTED WHEN THE INFECTION WAS DISCOVERED. IT WAS LATER REPORTED THAT ONE OF THE INS BATTERIES WAS REMOVED AND THE EXTENSION CUT. THE PATIENT WAS 'DOING WELL' AND WAS RE-IMPLANTED WITH AN INS ON (B)(6) 2012. REFER TO MANUFACTURER REPORT # 3004209178-2012-08529

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention