BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 6034475 · Received October 17, 2016

    Report

    Report Number
    3004209178-2016-21924
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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 THAT THE PATIENT HAD THE GASTRIC DEVICE PUT IN ON (B)(6) 2015. THE PATIENT HAD TO HAVE A HYSTERECTOMY BECAUSE THEIR BLADDER DROPPED. THE ONLY ISSUE WITH THE DEVICE WAS THAT BETWEEN HAVING THE IMPLANT SURGERY AND ALSO HAVING SURGERY FOR THEIR HYSTERECTOMY HAD CAUSED SOME PAIN IN THE STOMACH. THE PAIN BEGAN ABOUT 3 WEEKS AGO IN 2016. THE PATIENT WAS TOLD BY THEIR HEALTH CARE PROVIDER (HCP) THAT THE PAIN WAS RELATED TO HAVING THE IMPLANT SURGERY AND HYSTERECTOMY SURGERY. THE PATIENT WAS TOLD BY ONE HCP THAT THEIR UNIT WAS SET AT 10V. THE PATIENT WENT TO SEE ANOTHER HCP A FEW WEEKS AGO AND THEY SAID THEY WERE SET AT 6V. THE PATIENT WENT THROUGH THE STORE SECURITY GATE AND 3 TIMES IT BEEPED. THIS HAPPENED SOME LAST YEAR AND SOME THIS YEAR. THE PATIENT DIDN'T KNOW IF GOING THROUGH THE STORE LOWERED THE LEVEL TO 6V. THE INDICATIONS FOR USE FOR THIS PATIENT WERE GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686343 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR