BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3113841 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07708
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3888-45, LOT# V575373, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V570217, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON ICE RECENTLY AND HAD HIGH IMPEDANCES (10,000 OHMS) ON ELECTRODES 8 THROUGH 15. IT WAS NOTED THAT THE PATIENT DID NOT USE THAT LEAD. IT WAS FURTHER NOTED THAT THE PATIENT WAS REPROGRAMMED TO USE THE CHANNEL ONE LEAD (CONTACTS 0 THROUGH 7) ONLY, WHICH WORKED WELL FOR THE PATIENT. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215479 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