BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 4132891 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18099
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A HEART MONITOR PUT ON TODAY AND SHORTLY AFTER THAT THE PATIENT STARTED FEELING AN ELECTRIC SENSATION. THE PATIENT¿S HEALTHCARE PROVIDER WHO PRESCRIBED THE HEART MONITOR SAID THAT IT WOULDN¿T CAUSE ELECTRIC SENSATION BECAUSE IT ONLY SENSED ELECTRIC ACTIVITY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613254 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR