BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2903404 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00326
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD DEPLETED DUE TO NON-USE. IT WAS STATED THAT THIS WAS NORMAL BATTERY DEPLETION AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS AS A RESULT OF THE DEPLETION. THE PATIENT WAS NO LONGER USING THAT IMPLANT AS SHE FELT THAT IT WAS NOT HELPING HER PAIN ANYMORE. THE PATIENT HAD AN MRI ON (B)(6)-2012. IT WAS REPORTED THAT THE PATIENT FELT WARMTH IN HER BACK. THE PATIENT ALSO HAS ANOTHER INS THAT WAS NOT DEPLETED. IT WAS STATED THAT THE PATIENT WAS "NON-SYMPTOMATIC". THE PATIENT WAS DECIDING WHETHER OR NOT TO HAVE THE DEVICE EXPLANTED BEFORE HAVING ANOTHER MRI. IT WAS NOTED THAT THE PATIENT HAD A "FEW" OTHER MEDICAL ISSUES NOT RELATED TO HER PAIN OR IMPLANTS AND THAT THE PATIENT WAS EXPERIENCING ADDITIONAL SYMPTOMS OF ANXIETY DUE TO ANCILLARY HEALTH ISSUES. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10740 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