BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3082558 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07008
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 10, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF STIMULATION IN HER BACK AND STIMULATION IN THE WRONG LOCATION. AT HER TWO WEEK POST IMPLANT FOLLOW -UP VISIT SHE HAD A 60% REDUCTION IN PAIN WITH STIMULATION IN THE APPROPRIATE PAIN AREAS INCLUDING HER LOWER BACK. AT HER 30 DAY FOLLOW-UP VISIT SHE WAS NOT RECEIVING COVERAGE LIKE SHE DID AFTER IMPLANT AND DURING TRIAL. THE TOP THREE QUARTERS OF HER LEAD CAUSED ABDOMINAL STIMULATION. SHE HAD NO TINGLING ABOVE TAIL BONE WITHOUT GETTING ABDOMINAL STIMULATION. HER DAUGHTER DID HIT HER IN THE AREA OF THE INS AND SHE THOUGHT THIS MAY HAVE CHANGED THE STIMULATION. THE COMPANY REPRESENTATIVE THOUGHT THAT THIS EVENT COULD NOT HAVE CAUSED THE CHANGE IN STIMULATION. THE DEVICE WAS REPROGRAMMED USING ONLY ELECTRODES 8-15 AND THE PATIENT WAS GOING TO BE SENT HOME TO SEE IF IT PROVIDES THE COVERAGE TO THE TAILBONE AND LEG AREA THAT SHE NEEDED. IT WAS NOTED THAT CYCLING WAS SUCCESSFUL. SHE HAD STIMULATION IN TAIL BONE AREA BUT NO STIMULATION TO THE BACK. HER HEALTH CARE PROVIDER WAS CONSIDERING PULLING THE 0-7 TAIL AND USING THAT PORT FOR TWO PERIPHERAL QUAD PERCUTANEOUS LEADS CONNECTED TO AN EXTENSION. AN X-RAY WAS DONE AND IT DID NOT SHOW ANY MOVEMENT OF THE LEAD. THERE WERE NO ISSUES WITH IMPEDANCES, ALL WERE AROUND 900 OHMS. IT WAS CONFIRMED THAT THE REASON FOR THE STIMULATION DIFFERENCE WAS A MYSTERY. SINCE THE LEADS DID NOT MOVE, REVISION WAS NOT GOING TO BE A SOLUTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS LATER STATED THE PATIENT WAS BEING TRIALED ON THE DAY OF REPORT WITH PERIPHERAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183195 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