BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3162566 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10144
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ONE OF THE LEADS MIGRATED AND THE OTHER ONE WAS NOT ABLE TO BE PROGRAMMED HIGH ENOUGH TO THE AREA NEEDED. THE PATIENT REPORTEDLY FELT STIMULATION IN HER RIBCAGE AREA. A LEAD REVISION IN APRIL WAS REPORTED, IN WHICH THEY REMOVED BOTH LEADS AND REPLACED WITH A SURGICAL LEAD. IT WAS NOTED THE LEADS WERE STILL NOT ABLE TO COVER THE PATIENT'S LOWER BACK AND THE PATIENT ONLY FELT STIMULATION IN HER LEGS, BUTTOCKS, AND UPPER BUTTOCKS. THE PATIENT WAS LAST REPROGRAMMED "ABOUT" THREE WEEKS PRIOR TO REPORT. IT WAS LATER REPORTED THE SURGICAL LEAD GAVE THE PATIENT GREAT COVERAGE IN HER LEGS AND BUTTOCK, AND ¿FAIR¿ COVERAGE IN HER BACK. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT铠STIMULATOR WAS OFF AND NEVER WORKED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263319 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention