BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1200063 · Received October 15, 2008

    Report

    Report Number
    3004209178-2008-06584
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SHOCKING FROM HER DEVICE. NOTHING WOULD RELIEVE THE SENSATION. THE PHYSICIAN MENTIONED A POSSIBLE "LEAK OF ENERGY". DEVICE REPLACEMENT WAS PLANNED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    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 20 YR Required Intervention EXPLANTED:| LEAD: MODEL 4351| EXPLANTED:| LEAD: MODEL 4351| IMPLANTED: