BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6211749 · Received December 28, 2016

    Report

    Report Number
    3004209178-2016-27372
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    September 1, 2016
    Report Date
    March 29, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    UDI-DI
    00643169174993
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    ANALYSIS FINDINGS SHOWED GOOD STABLE OUTPUT ON ALL ELECTRODES. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. TELEMETRY WAS ACCEPTABLE. VISUAL INSPECTIONS SHOWED THAT THE CONNECTOR MODULE WAS SCRATCHED AND THE SHIELD/CAN WAS SCRATCHED. NO ABNORMAL HOTSPOTS WERE OBSERVED AND THERE WAS NO EVIDENCE TO SUGGEST THE COMPLAINT DEVICE BEHAVED OUT OF SPECIFICATIONS. IT WAS NOTED THAT THE BATTERY WAS NOT IN A NEW CONDITION. 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

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CALLER REPORTED SHE WAS CALLED TO CASE FOR FURTHER TROUBLESHOOTING AND IMPLANTABLE NEUROSTIMULATOR REPLACEMENT. THE CONSUMER WAS COMPLAINING OF NAUSEA SINCE (B)(6) 2016, ALONG WITH HIGH IMPEDANCE READINGS. IMPEDANCE WAS A FOLLOWS: C0, C1,01, 02, 03, 12, AND 13 ALL = >4K OHMS, C2=456 OHMS, C3=2417 OHMS, AND 23=2417 OHMS. THE PHYSICIAN AFTER FINDING HIGH IMPEDANCE, CAUSING FREQUENT OVERHEATING, TURNED STIMULATION OFF. SINCE THE DEVICE HAD BEEN OFF, THE CONSUMER WAS HAVING FREQUENT NAUSEA, VOMITING, AND ABDOMINAL DISCOMFORT. NO FALLS WERE NOTED AS RELATED TO THE ISSUE. THE CALLER NOTED BEING READY TO GO INTO THE OR. THE CALLER NOTED THAT CONSUMER¿S DEVICE LASTED THREE YEARS AND WAS WONDERING IF THIS CURRENT DEVICE WAS BURNING THE BATTERY FASTER. ESTIMATED LONGEVITY WAS END OF SERVICE (EOS) AT 3.6 YEARS BASED ON 2.9V/330PW/55HZ. 3+2- CYCLING 2 SECOND ON AND 3 SECOND OFF. INDICATION FOR USE INCLUDED GASTRIC STIMULATION. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THE INS WAS REPLACED. THE LEAD WAS NOT ADDRESSED SINCE IMPEDANCE TESTED FINE AFTER THE INS WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859786 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 00643169174993

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention