BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1083480 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04488
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE INS SITE FOR ONE WEEK. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHILE THE CAUSE OF THE INFECTION WAS BEING INVESTIGATED. NO SPECIFIC PATIENT SYMPTOMS OR TREATMENTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Q Hospitalization| R IMPLANTED:| LEAD MODEL 3887 LOT# J0118439V| EXPLANTED:| EXTENSION MODEL 7495-25 LOT# NAF011246N| EXPLANTED:| IMPLANTED: