BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 6158745 · Received December 9, 2016

    Report

    Report Number
    3004209178-2016-25526
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 16, 2015
    Report Date
    December 9, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    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 A LOSS OF THERAPY DUE TO A GRADUAL CHANGE IN THERAPY OR SYMPTOMS. THE PATIENT HAD NAUSEA, BLOATING, AND THEIR BLOOD SUGARS WERE OFF SINCE (B)(6) 2016. THE PATIENT JUST MOVED AND WOULD HAVE AN APPOINTMENT WITH A GASTRIC HEALTH CARE PROVIDER (HCP) IN (B)(6), BUT WANTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) TESTED BEFORE THAT. THE CONSUMER FURTHER REPORTED THAT THEIR DIABETIC HCP DID NOT HAVE TIME TO CHECK THEIR DEVICE. THE PATIENT WOULD HAVE AN APPOINTMENT ON (B)(6) 2016 AND WANTED A MANUFACTURER REPRESENTATIVE PRESENT. THE CONSUMER LATER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPY SINCE 2015. THE DEVICE HAD NOT WORKED FOR THE PAST YEAR AND THEY WERE NAUSEOUS. THE PATIENT HAD BEEN TRYING TO FIND AN HCP FOR THE PAST YEAR FOR REPLACEMENT. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTRIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814150 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR