BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3011001 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03915
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 18, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "LOSS OF THERAPEUTIC EFFECT" AND A "SHOCKING/JOLTING SENSATION." IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED A "JABBING AND UNCOMFORTABLE STIMULATION FEELING AT HER LEAD SITES" WHILE TURNING STIMULATION UP. THE "JABBING" AND "LOSS OF THERAPEUTIC EFFECT" WERE REPORTED TO OCCUR WITH "CERTAIN POSITIONING" OF THE PATIENT'S BODY, SUCH AS WHILE "TURNING OR STANDING." IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED SYMPTOMS AS "PAIN" AND THAT THE PATIENT EXPERIENCED "LESS THAN 50% THERAPY RELIEF" AT THE LOCATION OF THE LEAD. IMPEDANCE TESTING REVEALED THAT THE "IMPEDANCES WERE WITHIN NORMAL LIMITS." X-RAY RESULTS SHOWED "NO LEAD MOVEMENT." AFTER REPROGRAMMING, IT WAS REPORTED THAT THE "RIGHT LEAD SETTINGS WERE MORE COMFORTABLE" AND THERE WAS "NO JABBING" AT THE TIME OF REPORT. IT WAS ALSO REPORTED THAT THE "LEFT LEAD JABBED AT HIGHER AMPLITUDES AT ALL AREAS OF THE LEAD." ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114002 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