BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 6080632 · Received November 4, 2016

    Report

    Report Number
    3004209178-2016-23284
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 11, 2016
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED SHE HAD GONE THROUGH A SECURITY GATE AT A STORE (B)(6) 2016 AND THAT THE SECURITY TAG HAD NOT BEEN REMOVED BY THE STORE STAFF, SO THE MACHINE WENT OFF. LATER IN THE DAY, THE PATIENT WAS NOT FEELING WELL AND WAS NOT ABLE TO EAT, "LIKE THINGS HAD BEEN BACKED UP." THE TRANSMITTER WAS NOTED TO BE AT 7.4MHZ UP TO 8.8 MHZ AND THE RECEIVER WAS 8.0 MHZ. THE PATIENT INDICATED SINCE IMPLANT, EVERY MONTH THE PATIENT HAD BEEN GETTING BETTER UNTIL THIS INSTANCE. EMI EXPOSURE WAS REPORTED DUE TO THE SECURITY GATES/THEFT DETECTORS. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER VIA THE CONSUMER REPORTED SHE HAD FOLLOWED-UP WITH THE PHYSICIAN AND WAS TOLD SHE SHOULD BE "FINE." THE PATIENT WENT THROUGH ANOTHER THEFT DETECTOR ON THE DAY OF REPORT AT A STORE AND THE ALARM WENT OFF AS THEY HAD FORGOT TO REMOVE A TAG. THE PATIENT HAD NOT MENTIONED ANY SYMPTOMS. ON (B)(6), THE CONSUMER REPORTED THEIR ISSUES OF NOT FEELING WELL AND NOT BEING ABLE TO EAT (AS PREVIOUSLY REPORTED) HAD RESOLVED. THE PATIENT HAD GONE TO THE PHYSICIAN AND IT WAS INDICATED THE STIMULATOR WORKED OK. THE PATIENT'S INDICATION FOR USE WAS GASTRIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729564 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR