BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1071628 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03856
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED TIGHTNESS IN THE AREA OF PAIN AND NO STIMULATION THREE WEEKS POST-OP. IMPEDANCES WERE GOOD. THE PATIENT HAD REVISION SURGERY. A NEW LEAD WAS IMPLANTED. THE PATIENT FELT PARESTHESIA/TINGLING.

    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 Required Intervention EXPLANTED| EXTENSION MODEL 7489| EXPLANTED| LEAD MODEL 3887