BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 5999571 · Received October 5, 2016

    Report

    Report Number
    3004209178-2016-20422
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 5, 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

    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 THAT THE PATIENT HAD PAIN RIGHT ABOVE THE IMPLANTABLE NEUROSTIMULATOR (INS) BEGINNING IN (B)(6) 2016. THE PAIN WAS WORSE WHEN THE PATIENT SAT OR BENT OVER. THERE WERE TRAUMA OF FALLS THAT COULD BE RELATED TO THE ISSUE AS THE PATIENT WAS IN AN ABUSIVE RELATIONSHIP. THE PATIENT WAS TAKING SOME HYDROSOME PILLS THEY STILL HAD FROM SURGERY. THE PATIENT WAS LOOKING FOR A NEW MANAGING HEALTH CARE PROVIDER (HCP) AS THEY HAD MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650343 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR