BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2805066 · Received October 25, 2012

    Report

    Report Number
    3004209178-2012-09563
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    September 27, 2012
    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

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT# N236878, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3550-39, LOT# N236299, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3487A-56, LOT# V142203, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V386591, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 WEEK PRIOR TO REPORT, THE PATIENT WAS RECHARGING WHILE ASLEEP, AND THE PATIENT GOT 'SOME TYPE OF ELECTRICAL BURN,' WHERE THE ANTENNA WAS ON HER SKIN AND SHE GOT 'PRETTY RED AND BLISTERED.' THE PATIENT DID NOT GO TO A HEALTH CARE PROVIDER (HCP) FOR EVALUATION, AND IT WAS STATED THAT IT WAS HEALED UP. THE PATIENT HAD CHARGED THE DEVICE SINCE WITH NO REPORTED ISSUES. IT WAS STATED THAT THE THERMOMETER FEATURE HAD 'WORKED ACCORDINGLY' IN THE PAST. THE PAIN THAT WOKE THE PATIENT WAS AT THE SITE OF THE NEUROSTIMULATOR. NO ERROR CODES WERE REPORTED ON THE RECHARGER. ONE WEEK LATER IT WAS REPORTED THE PATIENT HAD TROUBLE RECHARGING DUE TO THE LOCATION. THE PATIENT HAD COUPLING ISSUES AND NEEDED TO LIE ON THE RECHARGER TO GET GOOD COUPLING. THE RECHARGER HAD BEEN USED 1 TIME SINCE THE BURN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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