BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1230551 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07436
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS DISLODGED AND MIGRATED. THE PATIENT EXPERIENCED A RETURN OF PAIN SYMPTOMS. THE LEAD WAS REPLACED. THE HCP REPORTED THE PATIENT OUTCOME AS 'RECOVERED WITHOUT SEQUELA'.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776| EXPLANTED:| LEAD: MODEL 3776| IMPLANTED: