BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3840470 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09867
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-45, LOT# VA03LVW, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# VA048DN, IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# VA048DN, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-45, LOT# VA03LVW, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE WIRES REVISED ON 2014 (B)(6) TO GET BETTER COVERAGE. IT WAS FURTHER REPORTED THAT THERE WAS NOT ENOUGH COVERAGE IN THE LEFT LEG. IT WAS NOTED THAT THE PATIENT REPORTED GOOD COVERAGE POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319331 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 00044 YR Required Intervention