BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2951360 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01511
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 21, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S RIGHT LEAD TIP WAS 'PROTRUDING AGAINST THE SKIN' AND PAINFUL TO THE TOUCH. THE AREA WAS PALPITATED AS A DIAGNOSTIC METHOD. THE LEAD WAS SURGICALLY REPOSITIONED SLIGHTLY DEEPER ON (B)(6) 2012. IT WAS STATED THAT THIS EVENT WAS RELATED TO THE DEVICE OR THERAPY AND THE SEVERITY WAS 'MILD.' IT WAS REPORTED THAT THE ISSUE RESOLVED WITHOUT SEQUELA ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT HAD PAIN AT THE LEAD SITE. NO FURTHER INFORMATION WAS RECEIVED. IF MORE INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56095 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 00064 YR Required Intervention