BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3081496 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01450
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION RECEIVED REPORTED THAT THEPATIENT¿S SITUATION HAD NOT CHANGED AND THE CAUSE OF THE ISSUE WAS UNKNOWN. IT WAS NOTED THAT NOTHING FURTHER WAS DONE AND OR IS PLANNED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY EXCEPT FOR THE REPORTED ¿FAILURE¿ WHICH HAS CONTINUED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITHOUT ANY PROBLEMS. FOUR DAYS LATER, THE PATIENT EXPERIENCED IRREGULAR STIMULATION, WHICH SKIPPED ONE PULSE ONCE IN TEN MINUTES, RESULTING IN DISCOMFORT. IMPEDANCE MEASUREMENTS WERE TAKEN AND IMPEDANCE BELOW 50 OHMS WAS SEEN BETWEEN 0/1. ALL OTHER MEASUREMENTS WERE NORMAL. THE IRREGULAR PULSE, WHICH WAS LIKE THE DEVICE SUDDENLY POWERING DOWN, OCCURRED THREE TIMES IN 10 MINUTES. WHEN USING THE 0 AND 1 CONTACTS THE PULSE ALSO OCCURRED ONCE IN TEN MINUTES, SO THE SETTINGS WERE CHANGED TO 1-/2+/6+ WITH THE PLAN TO CONTINUE TO FOLLOW-UP WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE SENSATION OCCURRED THE PATIENT FELT NO STIMULATION FOR A SECOND. AFTER THE SETTINGS WERE CHANGED THE PATIENT STILL FELT OCCASIONAL SUSPENSION OF STIMULATION. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE THOUGHT THERE WAS A LOOSE SETSCREW CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185792 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37714

    Patients

    Seq Age Sex Outcome Treatment
    1