BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3042152 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04903
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    October 3, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE X-RAY RESULTS WERE NORMAL. IT WAS NOTED NO INTERVENTIONS WERE PLANNED. ADAPTIVE STIM WAS REORIENTED AND ACTIVATED. IT WAS NOTED THE PATIENT WAS DOING ¿FINE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN A CAR ACCIDENT A WEEK PRIOR TO REPORT. THE PATIENT REPORTED THE DEVICE HAD ¿JUST GONE CRAZY¿ ON HIM FOLLOWING THE ACCIDENT. IT WAS FURTHER REPORTED THE PATIENT HAD BEEN INVOLVED IN A MOTORCYCLE ACCIDENT THREE WEEKS PRIOR TO 25-MAR-2013. THE MOTORCYCLE BACKREST COVERED HIS BACK AREA, BUT THE PATIENT WAS HIT FROM BEHIND AND PUT PRESSURE ON WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. THE PATIENT¿S SPINE HYPEREXTENDED AND FLEXED FORWARD. SINCE THEN STIMULATION HAD BEEN ¿ERRATIC¿. IN ADDITION, THE INS HAD NOT BEEN DETECTING THE PATIENT¿S CORRECT POSITION. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE POCKET SITE WAS STATED TO BE ¿SORE AND BRUISED.¿ THE AREA AT THE TIP OF THE LEADS WAS SORE AS WELL BUT FELT WORSE WITH STIMULATION OFF. THE MANUFACTURER REPRESENTATIVE DEACTIVATED THE INS¿S ADAPTIVE STIMULATION FUNCTION AND SUSPECTED THE INS MAY NOT BE DETECTING THE PATIENT¿S POSITION CORRECTLY DUE TO THE POCKET BEING LOOSE AFTER THE ACCIDENT. WHEN THE PATIENT WAS STANDING UP THE INS DETECTED ¿LYING FRONT¿. THE MANUFACTURER REPRESENTATIVE WAS GOING TO SEE THE PATIENT AGAIN IN THREE TO FOUR WEEKS TO ENABLE THE ADAPTIVE STIMULATION FUNCTION AGAIN. AN X-RAY WAS TAKEN ON 22-MAR-2013 BUT THE PHYSICIAN HAD NOT REVIEWED IT YET. THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. NO INTERVENTIONS HAD TAKEN PLACE OR WERE PLANNED AS OF 28-MAR-2013. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY BUT WAS HAVING ISSUES FROM THE ACCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145524 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