BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1902247 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09489
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    June 22, 2010
    Report Date
    October 30, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REFER TO MFR REPORT # 3004209178201009493. ON (B)(6) 2010, IT WAS INITIALLY REPORTED THAT WHILE DEVICE STIMULATION WAS ON, A PT HAD A LOSS OF THERAPEUTIC EFFECT. THE PT FELT THAT THE RIGHT LEAD WAS CAUSING "VIBRATIONS" DOWN THEIR RIGHT LEG, AND THAT THE LEFT LEAD WAS NOT COVERING HER PAIN AT ALL. THE ISSUE WAS NOTED TO OCCUR FOLLOWING THE IMPLANTATION OF THE DEVICE. IT WAS NOTED THAT A COMPANY REPRESENTATIVE WAS ABLE TO PROVIDE SOME HELP AT FIRST IN REGARDS TO THE STIMULATION ISSUE OF THE RIGHT LEG, WHILE THE PT WAS IN THE HOSPITAL. A REPROGRAMMING SESSION WAS SCHEDULED FOR (B)(6) 2010. ON (B)(6) 2010, IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS DONE ON (B)(6) 2010, AND THE PT WAS THEN RECEIVING COVERAGE AND WAS GETTING GOOD PAIN RELIEF. IT WAS NOTED THAT THE COVERAGE SHE WAS RECEIVING WAS EQUIVALENT TO THE GOOD PAIN RELIEF SHE HAD RECEIVED FOR FOUR YEARS. IT WAS NOTED THAT SHE WAS ON HER SECOND DEVICE BATTERY. ON (B)(6) 2010, IT WAS LATER REPORTED THAT THE PT AGAIN HAD A LOSS OF THERAPEUTIC EFFECT AND FELT "EXCRUCIATING" PAIN. UPON WAKING UP ON (B)(6) 2010, THE PT TURNED HER STIMULATION ON, AND INDICATED THAT IT FELT LIKE "HER INSIDES WERE GOING TO BURST OUT". THE PT ALSO HAD FELT LIKE THE IMPLANTED NEURO STIMULATOR (INS) HAD MOVED. THE AREA OF THE BODY EFFECTED WAS CLARIFIED AS BEING THE "BIKINI" AREA AND AROUND THE INS, WHICH WAS LOCATED ABOVE THE BIKINI LINE. THE PT WAS ADMITTED TO A HOSPITAL. A COMPANY REPRESENTATIVE WAS HEADING TO THE HOSPITAL TO HELP TURN THE STIMULATION ON. NO FALLS OR ACCIDENTS WERE INDICATED. THE INS THAT WAS INITIALLY IMPLANTED ON THE RIGHT SIDE ABOVE THE BUTTOCKS, WAS LATER MOVED IN (B)(6) TO THE "RIGHT FRONT". AT THE TIME OF THE REVISION PROCEDURE, IT WAS NOTED THAT THE LEADS WERE NOT LONG ENOUGH. INITIALLY, THE DEVICE COVERED THE PELVIC AREA, BUT AFTER BEING MOVED, THE DEVICE WAS NOTED AS NOT HAVING COVERED THE RIGHT SPOT AS IT WAS TOO LOW. REPROGRAMMING WAS ATTEMPTED ON (B)(6) 2010, BUT COVERAGE WAS NOT ACCOMPLISHED, AND IT WAS THOUGHT THAT THERE WAS SOMETHING WRONG WITH THE LEAD. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE148777N| EXPLANTED:| LEAD: MODEL 3487A, LOT # J0012729V| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA026463N| IMPLANTED:| EXTENSION: MODEL 7495-24, LOT # NAF016245N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB007574N| IMPLANTED:| LOT # NJK700478H| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA141399N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT #NJD043840N| EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB003421V| LEAD: MODEL 3487A, LOT # J0012729V| EXPLANTED: