BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2861389 · Received December 7, 2012

    Report

    Report Number
    3004209178-2012-11265
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 13, 2012
    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
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES WITH HER DEVICE. THE PATIENT HAD BEEN TRYING TO CHARGE HER DEVICE ALL DAY BUT COULD NOT GET COMMUNICATION. THE PATIENT LAST CHARGED THE DEVICE ABOUT FOUR TO FIVE DAYS AGO. THE PATIENT WAS UNABLE TO CONNECT WITH THE DEVICE USING THE PATIENT PROGRAMMER, AND STATED THAT HER RIGHT LEG WAS BOTHERING HER BECAUSE SHE COULD NOT TURN STIMULATION ON. THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    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