BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2772081 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08878
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL#(B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COULD NOT ADJUST STIMULATION WITH PATIENT PROGRAMMER. IT DID NOT "APPEAR" TO BE COMMUNICATION, OUT OF THE BOX OR BATTERY ISSUE. PATIENT HAD PROBLEMS WITH DEVICE IN THE PAST AND NEEDED TO RESET. PATIENT WAS ABLE TO TURN STIMULATION ON AND OFF WITH RECHARGER. IN ADDITION, RECHARGING WAS TAKING LONGER, BUT COUPLING WAS LOST DURING RECHARGING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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