BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3073416 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06784
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 4, 2013
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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 PREVIOUSLY REPORTED, ¿NOTHING IS WORKING SO WE'RE WONDERING IF THE STIMULATOR IS MALFUNCTIONING OR NOT.¿ THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS GASTROPARESIS. THE PATIENT HAD KIDNEY-URETER-BLADDER (KUB) RADIOGRAPHIES AND COMPUTED TOMOGRAPHY (CT) SCANS WHILE HOSPITALIZED. THE ASSOCIATED SIGNS AND SYMPTOMS WERE NAUSEA, VOMITING, ABDOMINAL PAIN, AND DECREASED APPETITE. THE PATIENT REQUIRED 'MANY' HOSPITALIZATIONS FOR NAUSEA AND VOMITING. THE PATIENT IMPROVED GREATLY AFTER HER GASTRIC PACEMAKER WAS INTERROGATED AND REPROGRAMMED VIA TELEPHONE. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, NAUSEA AND VOMITING. IT WAS NOTED THE NAUSEA STARTED ON (B)(6) 2013 WHICH WAS WHEN THE PATIENT WAS SEEN BY HER HEALTHCARE PROFESSIONALS (HCPS). THE PATIENT'S HCPS HAD TRIED TO GIVE THE PATIENT MEDICATIONS BUT THEY WERE NOT WORKING. IT WAS REPORTED THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174931 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization