BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3120517 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07912
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 1, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AFTER A FALL ON HIS BACK ON (B)(6) 2013. SINCE THAT DAY, THE PATIENT COULD ONLY FEEL STIMULATION IF HE ¿POPPED¿ HIS BACK OUT AND LEANED TO THE RIGHT. THE PATIENT WAS IN A LOT OF PAIN. THE PATIENT SUSPECTED THERE WAS SOMETHING WRONG WITH HIS LEAD DUE TO THE INTERMITTENT STIMULATION HE FELT. THE DEVICE WAS ON AND THE PATIENT COULD DECREASE AND INCREASE STIMULATION. THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH HIS PHYSICIAN ON (B)(6 )2013. IT WAS FURTHER REPORTED THAT A COMPANY REPRESENTATIVE MET WITH THE PATIENT. IMPEDANCE CHECKS WERE DONE. MULTIPLE ELECTRODES HAD HIGH IMPEDANCES AT OVER 10,000 OHMS. THE PATIENT WAS REPROGRAMMED AND PLANNED TO TRY THE PROGRAM FOR A WHILE. OF NOTE, THERAPY WAS MINIMAL. THE PATIENT REPORTEDLY FELL FREQUENTLY DUE TO NEUROLOGICAL DISEASE PROGRESSION AND WAS CURRENTLY IN A WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221688 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 00035 YR