BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4702207 · Received April 17, 2015

    Report

    Report Number
    3004209178-2015-07413
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 25, 2015
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-56, LOT# VA01YTF, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V994105, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA02G1L, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT WAS UNRESOLVED WITH NO FURTHER ACTIONS PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS WORSENING PAIN IN THE PATIENT'S UPPER BACK AND LEAD HIGH IMPEDANCE. THE STIMULATION WAS EXACERBATING THE PAIN IN THE UPPER BACK. THE PATIENT WAS REPROGRAMMED A FEW TIMES. DEVICE INTERROGATION INDICATED SOME ELECTRODES WERE OUT OF RANGE AT GREATER THAN 40,000. OUTCOME WAS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258490 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 00077 YR