BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3800796 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08763
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    October 19, 2013
    Report Date
    April 19, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST PAIN COVERAGE FOR THE OUTER PART OF BOTH LEGS. IT WAS REPORTED THEY HAVE STIMULATION ONLY FOR THE INNER LEGS. IT WAS REPORTED THE PATIENT HAS BEEN HAVING EPIDURALS FOR PAIN COVERAGE AND THEIR MOST RECENT ONE WAS ONE DAY PRIOR TO REPORT. IT WAS NOTED THEIR PAIN COVERAGE CHANGED APPROXIMATELY 6 MONTHS PRIOR TO REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CALLED A PAIN CENTER AND THEY WERE INFORMED THEY COULD NOT MEET WITH A MANUFACTURING REPRESENTATIVE WITHOUT CHANGING HEALTHCARE PROFESSIONALS (HCP). THE REPORTER STATED THEY SPOKE TO THEIR HCP WHO TOLD THEM THEY HAD A PATIENT WHO MET WITH A MANUFACTURING REPRESENTATIVE FROM MAINE. THE REPORTER FURTHER STATED THEY WOULD LOVE TO USE THEIR DEVICE, BUT IT WAS NOT HELPING THEM WITH IT PRESENT SETTINGS. IT WAS NOTED THE PATIENT HAD NOT MET WITH A MANUFACTURING REPRESENTATIVE. IT WAS FURTHER NOTED THE PATIENT STATED THE DEVICE WAS IRRITATING SO THEY TURNED IT OFF. THE REPORTER STATED IT WAS USELESS TO THEM BECAUSE THEY COULD NOT GET HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278928 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention