BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3346154 · Received September 12, 2013

    Report

    Report Number
    3004209178-2013-16170
    Event Type
    Injury
    Date Received
    September 12, 2013
    Report Date
    August 19, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 355031, LOT# N269260, IMPLANTED: 2010-(B)(6), PRODUCT TYPE SCREENING DEVICE. PRODUCT ID 355028, LOT# N242860, IMPLANTED: 2010-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 37092, LOT# 254990002, IMPLANTED: 2010-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 355031, LOT# N226893, IMPLANTED: 2010-(B)(6), PRODUCT TYPE SCREENING DEVICE. PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE PHYSICIAN ON 2013-(B)(6) FOR A DEVICE CHECK. IT WAS NOTED THAT THE LEAD THAT STIMULATED THE PATIENT¿S BACK WAS NOT WORKING RIGHT. IT WAS NOTED THAT THE PATIENT HAD TO CRANK THE STIMULATION UP VERY HIGH TO GET STIMULATION IN THE GROIN AND AS A RESULT IT PARALYZES HIS LEGS. IT WAS NOTED THAT THE ISSUE STARTED THE LAST COUPLE OF DAYS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD COMPONENTS OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD HAD FRACTURED ABOUT 7 WEEKS AGO. THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 AND HAD X-RAYS TAKEN 3 WEEKS LATER (RESULTS NOT REPORTED). THE PATIENT¿S SURGEON STATED THAT HIGH IMPEDANCES WERE SEEN THE POSTERIOR LEAD ON ¿6-8 PORTS¿ SO THERE WERE ¿ONLY 2 FUNCTIONING¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458236 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 00046 YR Required Intervention