BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3013690 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04010
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 5, 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

    PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(4) 2012 THAT THE PATIENT'S LEFT LEAD WAS CAUSING A "POKING AND BURNING FEELING" AT 0.4 VOLTS "AT THE TOP OF THE LEAD." IT WAS STATED THAT THE PATIENT WAS ONE WEEK POST OPERATION AND IN THEIR FIRST PROGRAMMING SESSION AND COULDN'T GET ANY STIMULATION ON THEIR LEFT SIDE. IT WAS ALSO STATED THAT DIFFERENT ELECTRODE COMBINATIONS WERE TRIED, PATIENT FELT NO STIMULATION SENSATION DOWN BACK OR LEG AT ALL, AND GOT SHARP, STABBING, BURNING PAIN FROM INCISION TO HER HIP AND AT THE BATTERY SIGHT. IT WAS THEN NOTED THE PATIENT STARTED TO SWEAT, HAD TO USE THE BATHROOM AFTER THIS OCCURRED BECAUSE OF NAUSEA FEELING IN STOMACH. IT WAS NOTED THAT THE PATIENT DID A SECOND TRIAL AND "IT WENT GREAT." IT WAS ALSO NOTED THAT THE PATIENT'S POCKET WAS SORE FROM SURGERY AND THE HEALTHCARE PROVIDER (HCP) SAID THE POCKET LOOKED GOOD IN TERMS OF HEALING. THE IMPEDANCES WERE REVIEWED AND THEY ALL "LOOKED GOOD." IT WAS ALSO STATED THAT USING ALL COMBINATIONS, THE PATIENT HAD "SHOOTING, SHARP PAIN FROM INCISION TO LEFT HIP BONE." IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE CAUSE OF THE EVENT WAS THAT THE LEAD HAD MIGRATED "CAUDAD" (TOWARDS THE TAIL END) RESULTING IN NO THERAPEUTIC BENEFIT. IT WAS STATED THAT THE PATIENT HAD A REVISION ON (B)(6) 2012 WHERE THE LEADS WERE REPLACED TO THE ORIGINAL PLACEMENT. THE PATIENT RECOVERED WITHOUT SEQUELA. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116640 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 Required Intervention