BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2010551 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01511
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    February 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION IN THE POCKET AND THE INS WAS GOING TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 PROGRAMMER: MODEL 37743, LOT# NKE160937N| ACCESSORY: MODEL 37752, LOT# NKA141070N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V530997011