BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6126724 · Received November 24, 2016

    Report

    Report Number
    3004209178-2016-24682
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    August 1, 2015
    Report Date
    December 16, 2016
    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
    NJ, 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 WANTED TO KNOW IF THE IMPLANTABLE NEUROSTIMULATOR (INS) COULD BE MADE SO THEY COULD TELL WHEN IT WOULD BECOME DEPLETED. THE PATIENT WANTED TO KNOW IF WHEN THE INS WAS REPLACED COULD THE LEADS BE LEFT AND ONLY THE STIMULATOR GET REPLACED. THE DEVICE GAVE THE PATIENT THEIR LIFE BACK. IF THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN¿T WORK, THEY WERE BACK ON TPN, LIQUID FOOD, AND HAD 24/7 NAUSEA AND VOMITING. IF IT WOULD EVER GET TO THE POINT WHERE THE STIMULATOR NEEDED TO BE REPLACED, BUT COULD NOT BE REPLACED FOR SOME REASON, THE PATIENT WOULD BE IN A WORLD OF HURT, COULD NOT EAT OR TAKE PILLS, NOTHING. THE INS STOPPED WORKING WITH NO WARNING AND JUST WENT DEAD AT THE END OF (B)(6) 2015. THE INS WAS REPLACED ON (B)(6) 2015. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTRIC STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THE DEAD IMPLANTED DEVICE INCLUDED THE DEVICE WAS AT 10 MILLIAMPS, 2 SECONDS ON, 3 SECONDS OFF, 55 HZ, 5.5 AMPLITUDE, AND PULSE 330 MICROSECOND. STEPS TAKE TO RESOLVE THE DEAD IMPLANTED DEVICE INCLUDED REPLACING THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777587 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention