BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3953870 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13459
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD AN UNRELATED SURGERY YESTERDAY. THE THERAPY WAS FINE YESTERDAY BUT TODAY, THE PATIENT WAS IN SEVERE PAIN, THE THERAPY WAS NOT WORKING. AN INFORMATION REQUEST WAS MADE REGARDING THE PATIENT PROGRAMMER (PP). WHEN SYNCHING WITH THE INS THE ANTENNA WAS NOT BEING USED. THE STIMULATION WAS ON GROUP D 2.1V BUT THE STIMULATION WAS USUALLY ON GROUP B. THE PATIENT TURNED THE STIMULATION OFF AND THEN TURNED STIMULATION ON. CHANGED TO DESIRED PROGRAM B, 0.7V AND BEGAN INCREASING STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432010 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR