BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3955650 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13489
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. THE PATIENT WAS GETTING STIMULATION IN THE ABDOMEN. THIS OCCURRED ABOUT ONE YEAR PRIOR WHEN THE PATIENT STEPPED INTO A HOLE. THE PATIENT NOTICED AN IMMEDIATE CHANGE IN STIMULATION. IMPEDANCES WERE >10,000 OHMS ON SOME ELECTRODE COMBINATIONS ON 0-1 ONLY. EIGHT TO FIFTEEN (8-15) WERE IN RANGE. A COMPANY REPRESENTATIVE WENT THROUGH ALL PAIRS BY CHANGING THE REFERENCE ELECTRODE AND SOME WERE IN RANGE AND SOME WERE >10,000 OHMS. SOME PROGRAMMING CHANGES WERE DONE. THE PATIENT WAS GOING TO HAVE AN XRAY TO DETERMINE LEAD LOCATION AND DETERMINE NEXT STEPS. IF UNABLE TO PROGRAM FOR BETTER COVERAGE A POSSIBLE LEAD REVISION WOULD BE DISCUSSED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE XRAY DETERMINED THAT THE LEADS DID NOT MOVE, DESPITE HIS STEPPING IN A HOLE AND THE PATTERN OF STIMULATION CHANGING. THE COMPANY REPRESENTATIVE HAD NOT BEEN CONTACTED BY THE PATIENT SINCE THE REPROGRAMMING ON (B)(6) 2014. THE CAUSE OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434713 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 00055 YR