BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4889327 · Received July 2, 2015

    Report

    Report Number
    3004209178-2015-12738
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-33, LOT# V993052, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# VA0KMPA, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-56, LOT# VA0NMM1, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA0PVJY, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL LAST WEEK AND WAS NOT FEELING STIMULATION IN THEIR BACK (PNS LEADS). THE PATIENT STARTED FEELING AGAIN LAST NIGHT, BUT IT FELT STINGY NOT PULSATING. THE PATIENT HAD A BURNING SENSATION AND LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED. THE REPRESENTATIVE ADDED GROUP C FOR MORE COMFORTABLE BACK COVERAGE. REPROGRAMMING PRODUCED GOOD STIMULATION COVERAGE. THE PATIENT WAS DOING FINE AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430781 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR