BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1231161 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07389
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPEDANCE ABNORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCES WERE OUTSIDE NORMAL RANGE. THE DECISION WAS MADE TO OBSERVE THE PT'S SITUATION. NO INTERVENTION WAS NEEDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANTED:| IMPLANTED:| LEAD: MODEL 4351| EXPLANTED:| EXPLANTED:| LEAD: MODEL 4351