BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2904926 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00380
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    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
    MN, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NORMALLY FELT 'THE PULSATING' BUT HAD NOT FELT IT IN THE LAST 3-4 WEEKS AND HER SYMPTOMS HAD RETURNED TO WHAT THEY WERE LIKE BEFORE. THE PATIENT HAD AN INCREASE IN NAUSEA AND WAS VOMITING SEVERAL TIMES A DAY. THE REPORTER INDICATED THAT THERE HAD BEEN A REDUCTION IN SYMPTOMS TO ONCE OR TWICE A WEEK, BUT IT WAS 1-5 TIMES A DAY AT THE TIME. IT WAS NOTED THAT THE PATIENT'S ABDOMINAL PAIN HAD ALSO INCREASED. THE REPORTER STATED THAT THE PATIENT WAS CONCERNED IF THE DEVICE WAS MALFUNCTIONING AND NOT WORKING OR IF SHE HAD A VIRUS BUG. IT WAS NOTED THAT THE SYMPTOMS DID NOT OCCUR GRADUALLY, BUT IT WAS RATHER ALL OF A SUDDEN FOLLOWING SOME TYPE OF ENVIRONMENTAL EXPOSURE. THE PATIENT WAS EXPOSED TO A THEFT DETECTOR, FROM A SECURITY GATE AT A STORE DIFFERENT FROM WHAT THE PATIENT REGULARLY FREQUENTED, WHICH CAUSED HER DEVICE TO BE TURNED ON. IT WAS NOTED THAT THE PATIENT WAS AT THE HIGHEST SETTING AT THE TIME OF THE REPORT AND COULDN'T GO ANY HIGHER. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE HEALTHCARE PROVIDER HAD NOT SEEN THE PATIENT AFTER THE REPORTED EVENT OF LOSS OF EFFECTIVENESS. THE PATIENT OUTCOME WAS LISTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12433 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1