BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3093460 · Received May 6, 2013

    Report

    Report Number
    3004209178-2013-07324
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN, SERIAL# UNKNOWN, PRODUCT TYPE: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTED NEUROSTIMULATOR (INS) WAS REMOVED AFTER 2-3 DAYS OF IMPLANT. IT WAS REPORTED THE INS WAS MAKING THE PATIENT "MORE NUMB AND INCREASING HER TINGLES." ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER REPORTED THE DEVICE SYSTEM WAS EXPLANTED BECAUSE THE PATIENT HAD DEVELOPED FURTHER WEAKNESS IN HER BILATERAL LOWER EXTREMITIES. IT WAS NOTED THE PATIENT WAS WHEELCHAIR BOUND PRE-OPERATIVELY. INITIAL POST-OPERATIVE PERIOD THE PATIENT HAD BASELINE STRENGTH AND FUNCTION AND THEN DEVELOPED WEAKNESS. A CT SCAN WAS PERFORMED WITH NO DEFINITIVE DIAGNOSIS. THE NEUROSURGEON ON CALL DECIDED TO EXPLANT THE ENTIRE SYSTEM. THE DAY FOLLOWING EXPLANT THE PATIENT WAS AT BASELINE IN REGARDS TO HER STRENGTH AND FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196535 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 Required Intervention