BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2854612 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11060
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NERVE DAMAGE IN L5 AND L4. IT WAS STATED THAT THE PATIENT HAD AN OPIATE ADDICTION AND "GOT OFF OF THEM AFTER GOING TO REHAB," BUT HE HAD BEEN HAVING TROUBLE WALKING AND HIS DOCTOR SUGGESTED THE SPINAL CORD STIMULATOR (SCS). IT WAS COMMUNICATED THAT AFTER THE IMPLANT, THINGS "KIND OF WENT BAD" AND THAT "THE DRUG THEY USED ON HIM MIGHT HAVE STIRRED THINGS UP." WHEN THE PATIENT WENT TO SEE HIS DOCTOR IN (B)(6) OF 2012 FOR AN APPOINTMENT, HIS LEGS WERE "JUMPING FOR AN HOUR AND 15 MINUTES." HE WAS PRESCRIBED KLONOPIN, AND IT WAS STATED THAT SINCE THEN, "THE NERVE PROBLEMS HAD BEEN A PROBLEM". IT WAS DESCRIBED THAT THE PATIENT HAD BEEN "WEANING OFF" THIS DRUG FOR ALMOST A YEAR AND WAS ALMOST DONE WITH IT. IT WAS STATED THAT THE PATIENT "DID REALLY LOUSY WITH DRUGS." IT WAS REPORTED THAT PATIENT'S DOCTOR HAD NOTED CONCERNING THE LEADS THAT "THEY WERE IMPLANTED WHERE THEY WERE SUPPOSED TO BE." THE PATIENT WAS GOING TO SEE A NEW NEUROLOGIST TO HAVE HIM "TAKE A LOOK AT THE NERVE DAMAGE." IT WAS STATED THAT THE LEADS NEEDED TO BE MOVED TO A DIFFERENT POSITION. A COUPLE OF DAYS AFTER THE INITIAL REPORT, THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY BUT HAS NOT SOUGHT FURTHER HELP. IT WAS STATED THAT A DOCTOR HAD PUT THE PATIENT UNDER AN X-RAY AND HAD SAID "THE PROBES ARE IN PLACE T-AREAS." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other