BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3952856 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13418
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 3, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DOCTOR WAS PLANNING ON DOING A REVISION ON THE PATIENT¿S DEVICE. IT WAS STATED THE PATIENT WAS HAVING PAIN AT THEIR POCKET SITE. IT WAS NOTED THE DOCTOR FELT THEY MAY HAVE PUT IT TOO LOW AND THEY WERE PLANNING ON MOVING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430841 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention