BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3880950 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11746
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    December 18, 2013
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTIONING DEVICE. IT WAS NOTED THAT THE PATIENT¿S DEVICE BATTERY HAD EXPIRED. IT WAS NOTED THAT IT WAS SURGICALLY REPLACED. IT WAS NOTED THAT THE REPORTED EVENT WAS ¿HOSPITALIZATION.¿ IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS NOTED THAT THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS BATTERY DEPLETION. IT WAS NOTED THAT IT WAS UNKNOWN IF IT WAS NORMAL OR ABNORMAL. IT WAS NOTED THAT THE REPLACEMENT TOOK PLACE ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT EXPERIENCED RECURRENT NAUSEA, VOMITING, AND "UPPER ABD PAIN." IT WAS NOTED THAT SYMPTOMS WERE WORSENING OVER THE LAST 3 OR 4 MONTHS. IT WAS NOTED THAT A CT SCAN WAS DONE AND NEGATIVE FOR OTHER CAUSES OF THE SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BATTERY DEPLETION WAS EXPECTED DUE TO HIGH SETTINGS PLACED BY THE PHYSICIAN. IT WAS NOTED THAT NO ABNORMAL BATTERY DEPLETIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357462 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Hospitalization| R