BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3103228 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07471
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, MODEL # 37712, SN (B)(4), FOUND NO ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A, LOT# J0217066V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SURGERY TO TROUBLESHOOT THE SHOCKING AND JOLTING THE PATIENT HAD EXPERIENCED. IT WAS NOTED THE SENSATIONS THE PATIENT EXPERIENCED WERE 'VERY INCONSISTENT' ON BOTH LEADS. IT WAS ADDED THAT DURING SURGERY, BOTH LEADS WERE DETACHED FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) AND TESTED AGAIN. ADEQUATE STIMULATION COVERAGE WAS ACHIEVED AND THE NEW INS WAS ATTACHED. IT WAS ADDED THE LEADS AND EXTENSIONS WERE 'OKAY.' IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202633 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