BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3537022 · Received December 24, 2013

    Report

    Report Number
    3004209178-2013-24012
    Event Type
    Malfunction
    Date Received
    December 24, 2013
    Report Date
    December 9, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 355029, LOT # N123031, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERSTIMULATION SENSATION. THE PATIENT REPORTED THAT THE LAST TIME THEY WERE ADJUSTED IT ¿JUST WAS NOT WORKING WELL.¿ IT WAS NOTED THAT THE PATIENT NEEDED TO ADJUST THE PULSE LOWER BUT THERE WERE LIMITS SET AND THE PATIENT COULD NOT GO BEYOND AND THAT THEY HAD TRIED. THE PATIENT STATED THAT IT WAS ¿ZAPPING THE NERVE¿ AND CAUSING PAIN. THE PATIENT STATED THAT THEY WERE LAST REPROGRAMMED ¿MAYBE ABOUT ONE YEAR¿ PRIOR TO REPORT BUT DID NOT REMEMBER TIMEFRAME. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674807 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