BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3872722 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11582
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 28, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(6), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS USING THEIR INS UP UNTIL (B)(6) 2014 BUT THEY DID NOT FEEL IT WAS WORKING WELL. ON (B)(6) 2014, THE PATIENT FELT THEIR LEGS TURN TO ¿JELLO¿ AND THEY FELL DOWN. THIS EVENT CAUSED THE PATIENT TO GO TO THE EMERGENCY ROOM WHERE THEY WANTED TO PERFORM AN MRI BUT WERE UNABLE TO DUE TO THE STIMULATOR. THEY PERFORMED CT SCANS WHICH WERE INCONCLUSIVE. THE PATIENT¿S DOCTOR FELT THAT REMOVAL OF THE INS FOR THE MRI WAS NECESSARY. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 5 DAYS WITH A STEROID PRESCRIPTION AND PHYSICAL THERAPY. THE PATIENT HAD PAIN IN THEIR LEFT ILIAC CREST WHICH WAS IN THE OPPOSITE SIDE OF THE INS. ¿2 PATIENT SESSIONS SEEMED WORSE¿ BUT AFTER 9 DAYS OF STEROIDS IT SEEMED TO ALLEVIATE THE PAIN IN THE ILIAC JOINT. THE PATIENT THEN STARTED TO FEEL PAIN UNDER THEIR INS LOCATION. THE PATIENT SUSPECTED THAT THE STABBING PAIN IN THE ILIAC CREST WAS DUE TO A BONE GRAFT THAT THEY HAD PERFORMED AND THEN THE PATIENT DEVELOPED A STAPH INFECTION. THE PATIENT THOUGHT THAT THE PAIN IN THE ILIAC CREST WAS THE PRIMARY PAIN AND THE PAIN UNDER THE INS WAS SECONDARY PAIN. THE PATIENT SAW ANOTHER DOCTOR ON (B)(6) WHO WAS WILLING TO REMOVE THE PATIENT¿S INS AND LEADS BUT THEY WERE WAITING FOR INSURANCE APPROVAL. THE PATIENT HAD BEEN BEDRIDDEN SINCE (B)(6) AND NOTED 8 BACK SURGERIES. THE PATIENT FELT LIKE THEIR LEFT HAND DID NOT KNOW WHAT THEIR RIGHT HAND WAS DOING AND ADMITTED TO A MEDICAL PROBLEM WHICH THEY FELT WAS POINTING AT THE STIMULATOR OR A LOOSE SCREW IN THEIR BACK. THE PATIENT CALLED LATER AND NOTED THAT THEIR BATTERY HAD BEEN DEAD SINCE MARCH. THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF FROM THE DEVICE AND WANTED TO GET THEIR DEVICE REMOVED. THE PATIENT HAD THEIR STIMULATION OFF SINCE (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349352 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 Required Intervention