BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6080528 · Received November 4, 2016

    Report

    Report Number
    3004209178-2016-23279
    Event Type
    Injury
    Date Received
    November 4, 2016
    Report Date
    December 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A REPRESENTATIVE REPORTED THE PATIENT HAD AN ABSCESS/WOUND INFECTION. IT WAS UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS UNKNOWN IF ANY DIAGNOSTICS OR INTERVENTIONS HAD BEEN PERFORMED. IT WAS UNKNOWN WHEN THE EVENT HAD OCCURRED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT BUT AN EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLANNED FOR (B)(6) 2016. THE PATIENT'S INDICATION FOR USE WAS GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2016. THE DOCTOR WAS IMPLANTING NEW LEADS AND A BATTERY ON THE DAY OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729815 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention