BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6183148 · Received December 16, 2016

    Report

    Report Number
    3004209178-2016-26683
    Event Type
    Injury
    Date Received
    December 16, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS COMPLETED AND THERE WERE NO ANOMALIES ASSOCIATED WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. 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.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED A CONSUMER HAD THEIR SYSTEM EXPLANTED AND REPLACED BECAUSE IT WAS ¿INEFFECTIVE -MFR DEFECT PER SURGEON.¿ NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831112 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention