BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 6140019 · Received December 1, 2016

    Report

    Report Number
    3004209178-2016-25017
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    May 1, 2015
    Report Date
    December 1, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. 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 2 WEEKS AFTER THE REPLACEMENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED ON (B)(6) 2015, THE PATIENT KNEW THE INS WASN¿T WORKING IN (B)(6) 2015. THE PATIENT COULDN¿T REALLY EXPLAIN HOW THEY KNEW. THE PATIENT WENT BACK TO SEE THEIR HEALTH CARE PROVIDER (HCP) ABOUT EVERY 2 WEEKS UNTIL (B)(6) 2015 AND THE HCP TOLD THEM THE INS WAS FINE AND JUST NEED TO BE INCREASED. THE PATIENT GOT A SECOND OPINION WHO DID A SCOPE AND FOUND THE LEADS TO BE BROKEN. THE PATIENT HAD THEIR LEADS REVISED IN (B)(6) 2016 AND HAD GOOD THERAPY NOW. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTRIC STIMULATION. (B)(4): PROBLEMS W/ INS, REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788375 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 00643169174993

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention