BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2842755 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10661
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V025707, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE RECHARGER, PRODUCT ID 37743FA, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37701, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE IMPLANTABLE, NEUROSTIMULATOR PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3587A, LOT# N0047380, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD, FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A SURGICAL REVISION. THE PATIENT HAS TWO IMPLANTED SYSTEMS. THE STATUS OF THE RESTOREPRIME (B)(4) WAS UNKNOWN, BUT IT WAS BELIEVED TO BE NOT IN USE. THE RESTOREULTRA (B)(4) WAS TO BE MOVED FROM THE BUTTOCK TO THE ABDOMEN AS IT WAS A POSSIBILITY THAT THE PATIENT WAS HAVING RECHARGING ISSUES. IT WAS LATER REPORTED THAT THE REVISION TOOK PLACE. THERE WERE NO IMPEDANCES FOUND INTRA-OPERATIVELY. THE BATTERY HAD DEPLETED BECAUSE THE PATIENT HAD THREE STRIKES/OVERDISCHARGES. THE PATIENT WAS "FINE."

    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