BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2231108 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06902
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION BECAUSE HE WAS NOT RECEIVING STIMULATION HIGH ENOUGH IN HIS LOW BACK AND HE ONLY FELT STIMULATION ON THE RIGHT SIDE DUE TO LEAD MIGRATION POST IMPLANT. THE PATIENT ORIGINALLY HAD GOOD COVERAGE, BUT AFTER THE MIGRATION OPTIMAL COVERAGE WAS LOST. THE PATIENT RECOVERED FROM THE REVISION W/O SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149667N| LEAD: MODEL 39565-65, LOT# V459341029| ACCESSORY: MODEL 37752, LOT# NKA141514N