BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6096894 · Received November 11, 2016

    Report

    Report Number
    3004209178-2016-23817
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 11, 2016
    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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD IDIOPATHIC GASTROPARESIS WITH GASTRIC STIMULATOR PLACEMENT, REVISION, AND THEN FAILURE. RECENTLY THE PATIENT WAS HAVING DIFFICULTIES AND THE SYSTEM WAS INTERROGATED. IT SHOWED A RESISTANCE IN THE SYSTEM OF GREATER THAN 800 OHMS, WHICH SUGGESTED A BREAK IN THE SYSTEM. THE HCP MET WITH THE PATIENT AND THEY ELECTED TO PROCEED WITH REPLACEMENT. THE PATIENT HAD A GASTRIC STIMULATOR REPLACEMENT INCLUDING THE LEADS ON (B)(6) 2016. THE RESISTANCE IN THE SYSTEM WAS APPROXIMATELY 540 OHMS AFTER REPLACEMENT AND IT WAS SET TO THE NOMINAL SETTINGS. THE PATIENT ALSO HAD AN UPPER GASTROINTESTINAL ENDOSCOPY. THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746367 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 00643169174993

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention