BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1002595 · Received February 8, 2008

    Report

    Report Number
    3004209178-2008-00598
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Report Date
    January 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL. IF FURTHER INFO IS REC'D OR THE DEVICE RETURNED, A F/U MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE WAS AT THE AIRPORT AND HER ENTERRA DEVICE MAY HAVE CAUSED THE ALARMS TO SOUND. TWO DAYS LATER, SHE VISITED THE GROCERY STORE AND SUBSEQUENTLY FELT A VIBRATION IN HER STOMACH AND THEN SHOCKING SENSATIONS. 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 IMPLANTED| EXPLANTED| LEAD MODEL 435 LOT # NHT002851N| EXPLANTED| IMPLANTED| LEAD MODEL 4351 LOT # NHT002854N