BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2894906 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00088
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 12, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. 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 WAS HAVING COUPLING AND/OR COMMUNICATION ISSUES AND WAS GETTING A RECHARGE RECHARGER WARNING SCREEN . THE PATIENT WAS ALSO EXPERIENCING NO STIMULATION SENSATION AND STIMULATION HAD BEEN OFF FOR SOME TIME. HOWEVER, THE PATIENT WAS UNSURE FOR HOW LONG THAT WAS. THE REPORTER INDICATED THAT SINCE ONE WEEK AFTER THE PATIENT HAD SURGERY, SHE HAD PAIN IN HER RIGHT LEG BUT NEVER DID BEFORE. THE PATIENT HAD TRIED TURNING STIMULATION ON THE MORNING OF THE REPORT BECAUSE SHE WAS IN PAIN EVERY DAY, HOWEVER IT DIDN'T WORK. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539 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