BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3081123 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06969
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N311906, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED IMPEDANCE READINGS 'GREATER THAN 20,000 OHMS.' IT WAS FURTHER REPORTED THAT 'AT 3 VOLTS, ELECTRODE 0 SHOWED 8158 OHMS.' IT WAS NOTED THE '0 CONTACT WAS NOT BEING UTILIZED.' ADDITIONAL INFORMATION STATED THAT 'AFTER RUNNING ANOTHER IMPEDANCE [TEST] AT A HIGHER VOLTAGE, THE ELECTRODE IN QUESTION WAS HIGH BUT WITHIN NORMAL RANGE.' IT WAS STATED THAT THE PATIENT THEN UNDERWENT AN MRI OF THEIR 'HEAD/BRAIN' AND 'DID WELL THROUGH THE SCAN WITHOUT COMPLICATIONS.'

    Description of Event or Problem · 1

    IT WAS NOTED THAT AN IMPEDANCE CHECK SHOWED ONE ELECTRODE WAS OUT OF RANGE (OOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183354 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