BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2241050 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06496
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE STIMULATOR WAS TURNED ON AND PROGRAMMED ABOUT ONE MONTH AFTER IMPLANTATION AND WAS "OK." A FEW DAYS LATER, THE PT EXPERIENCED A LACK OF "EFFICIENCY" OF THE DEVICE AND OF THE STIMULATION TO RELIEVE BACK PAIN. THE "ORIENTATION" OF THE DEVICE WAS REDONE, AND THE INITIAL PARAMETERS WERE REPROGRAMMED. A GROUP WAS CREATED IN ORDER FOR THE PT TO USE THE STIMULATION WITHOUT THE DEVICE ACTIVATED. DURING THE REPROGRAMMING SESSION THE DEVICE WORKED FINE. WHEN THE PROGRAMMING SESSION ENDED ON "LYING ON THE RIGHT SIDE," AND THE PT STOOD UP, THE PT STILL HAD THE LEVEL OF STIMULATION ASSOCIATED WITH "LYING ON THE RIGHT SIDE," ALTHOUGH THE PROGRAMMER RECOGNIZED THE UPRIGHT PT POSITION. THE PROGRAMMING WAS RECHECKED AND, THEN, THE DEVICE WORKED FINE. THERE WAS NO INJURY TO THE PT. THE PT WAS TO RETURN TO FURTHER EXPLORE THE ISSUE. THE PT'S OUTCOME WAS NOTED TO BE "OK." IT WAS LATER REPORTED THAT ELECTRODE AND GROUP IMPEDANCES WERE FINE (AROUND 900 OHMS). X-RAYS WERE PERFORMED AND SHOWED THAT THE ELECTRODES ON ONE SIDE WERE NOT "RECTANGLES," AND THAT THE LEAD WAS NOT MEDIAL. REPROGRAMMING WAS ATTEMPTED, BUT THE RESULTS WERE WORSE. THE INITIAL PROGRAMMED SETTINGS WERE USED: WITH THE LEFT SIDE ABLE TO BE STIMULATED WITH ALMOST ALL THE ELECTRODES, AND THE RIGHT SIDE ONLY ABLE TO BE STIMULATED WITH THE 5, 6, AND 7 ELECTRODES (SET AT 5+ 6- 7+). ON (B)(6) 2011, AND (B)(6) 2011, "ORIENTATION" WAS MADE FOR THE DEVICE ACTIVATION AND THEN FOR THE DEVICE TROUBLESHOOTING. THE POSITION WAS CHECKED USING THE PROGRAMMER AND IT WAS ALWAYS "FINE." NO INTERVENTION WAS PLANNED AT THAT TIME. IT WAS SUGGESTED THAT SINCE THE DEVICE WAS "REALLY NEAR" THE MEDIAL LINE ON THE PT'S BUTTOCK, THE DEVICE MAY BE MOVED. RECHARGING WAS VERY DIFFICULT GIVEN THE POSITION OF THE DEVICE, TOOK LONGER, AND NEEDED TO BE PERFORMED MORE FREQUENTLY. DURING RECHARGING, THE THERMOMETER APPEARED ON THE SCREEN. ALSO, THE AMPLITUDES ON THE DEVICE WERE UNPREDICTABLE AS SOMETIMES THE STIMULATION STOPPED AND SOMETIMES THE STIMULATION WAS TOO STRONG. IT WAS NOTED THAT AT THE LAST REPROGRAMMING, THE AMPLITUDES WERE SETTLED WHEN THE PT WAS STANDING. THE PT, THEN, LAY DOWN (WITH OTHER AMPLITUDES SET). WHEN THE PT STOOD UP, THE STIMULATION SENSATION (WITH THE SAME AMPLITUDES SET) WAS DIFFERENT THAN BEFORE. THE PT WAS TO SEE THE PHYSICIAN ON (B)(6) 2011. IT WAS LATER REPORTED THAT THE PARESTHESIA COVERAGE WAS WORSE THAN IT WAS AT THE BEGINNING. THE MFR REP WAS TO ATTEMPT TO REPROGRAM THE PT. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37714 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANTED:| LEAD: MODEL 39565, LOT# UNK| EXPLANTED: