BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3871792 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11541
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 22, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# N(B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED THEIR BATTERY REPLACED AS SOON AS POSSIBLE AND THEY WERE HAVING DIFFICULTY FINDING AN IMPLANTING HEALTH CARE PROVIDER (HCP). THE PATIENT¿S HCP NO LONGER IMPLANTED IT AND THE CONTACT THEY PROVIDED WAS NOT ABLE TO REPLACE THE STIMULATOR FOR A COUPLE OF MONTHS. IT WAS NOTED THAT THEY HAD NOT BEEN ABLE TO REACH THEIR MANUFACTURER REPRESENTATIVE AND THEY CALLED 10 TIMES TODAY AND IT WAS ALWAYS BUSY. THE PATIENT HAD NO BOWEL MOVEMENTS IN ALMOST 1.5 MONTHS AND THEY FIGURED OUT TODAY BY SEEING ANOTHER HCP THAT THE BATTERY WAS DEAD. IT WAS REPORTED THAT THEY CALLED THEIR HCP TODAY AND THEY NO LONGER WORKED AT THE HOSPITAL. THE PATIENT WAS VERY ILL AND NEEDED TO HAVE THE BATTERY REPLACED AS SOON AS POSSIBLE. IT WAS NOTED THAT THE PATIENT¿S HCP SAID THAT THE BATTERY WOULD LAST 18 MONTHS BUT 18 MONTHS HAD NOT PASSED AND NOW THE PATIENT ¿HAD NOT¿ AND WAS SUFFERING EVERY DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS THE BATTERY LIFE WAS SHORT. IT WAS STATED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS NOTED THE BATTERY WAS DEAD PREMATURELY AND THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL. IT WAS STATED THE PATIENT HAD SYMPTOMS OF NAUSEA, VOMITING AND RECURRENT SYMPTOMS. THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY, NON-SERIOUS INJURY OR ILLNESS, AND SERIOUS INJURY OR ILLNESS THAT WAS ONGOING. IT WAS LATER REPORTED THE PATIENT HAD A ¿STOMACH PACEMAKER¿ AND THE BATTERY WAS NOT WORKING. IT WAS NOTED THE PATIENT¿S BATTERY WAS CHANGED ON (B)(6)-2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351017 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention