BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4232669 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21083
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 28, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ANOTHER LEAD PUT IN THEIR BACK ON MONDAY PRIOR TO THE REPORT. IT WAS LATER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. THE PATIENT WAS WAITING FOR THE LEAD TO SETTLE IN. THE PATIENT HAD A LEAD REVISION DUE TO LEAD MIGRATION AFTER THE INITIAL IMPLANT, ON (B)(6). BEFORE REVISION THE PATIENT WAS GETTING ABOUT 50% RELIEF, BUT NOW WITH THE LEAD REVISION WAS GETTING 90% RELIEF.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EXACT CAUSE OF THE LEAD MIGRATION WAS NOT DETERMINED, OTHER THAN THE PATIENT REMEMBERING THAT THINGS CHANGED AFTER REACHING TO THE FLOOR FOR SOMETHING. THE PATIENT WAS DOING GREAT AND STILL HAD 90% RELIEF OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713649 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 00075 YR Required Intervention