BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3884967 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11841
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 2, 2014
    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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTIONING GASTRIC STIMULATOR WITH EROSION OF THE LEADS INTO THE STOMACH. IT WAS NOTED THAT THE PATIENT UNDERWENT SURGERY TO REPLACE HER GASTRIC STIMULATOR BATTERY ON (B)(6) 2014. IT WAS NOTED THAT THE DEVICE WAS REPLACED AND THE DEVICE WAS FUNCTIONING. 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 COMPLICATION SAND 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 THE REPORTER COULD NOT SEE ANYWHERE WHERE THE LEADS ERODED. IT WAS NOTED THAT THEY JUST FOUND BATTERY EXPIRATION WITH NAUSEA AND CONSTIPATION. IT WAS NOTED THAT THE BATTERY WAS REPLACED ON (B)(6) 2014. 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
    362040 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| L| R