BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5247905 · Received November 24, 2015

    Report

    Report Number
    3004209178-2015-23380
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Report Date
    November 3, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMTIANT MEDICAL PRODUCTS: PRODUCT ID: 37092, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3487A-33, LOT# V101633, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# V101633, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PROGRAMMER ANTENNA HAD A FRAYED OR DAMAGED CORD. THE PATIENT WAS NOT ABLE TO CHARGE THEIR IMPLANT. IT WAS REPORTED THAT THE PATIENT WAS MEETING A MANUFACTURER REPRESENTATIVE TO POSSIBLY HAVE THE DEVICE JUMP STARTED. NO SYMPTOMS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDES LUMBAR RADICULOPATHY. NO OUTCOME OR INTERVENTION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776592 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 00050 YR