BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3120794 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07934
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 29, 2013
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-33, LOT# V546812, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT# V650832, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT# V594725, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V999674, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND A SHOCKING/JOLTING SENSATION. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED TO A NEW LOCATION BECAUSE THE PATIENT REPORTED IT WAS TENDER AND PAINFUL AT THE INS POCKET. IT WAS NOTED THE DEVICE WAS FUNCTIONING ¿FINE.¿ THE PATIENT¿S LEADS WERE REPLACED AND MOVED BECAUSE THE PATIENT WAS NOT GETTING ¿APPROPRIATE¿ THERAPY. THE NEW LEADS WERE PLACED ¿IN AN AREA WHERE STIMULATION WAS BETTER FOR THE PATIENT.¿ IT WAS NOTED IMPEDANCE TEST ON THE OLD LEADS THAT WERE REMOVED ALL CAME BACK ¿FINE.¿ THERE WERE NO PATIENT INJURIES REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221534 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