BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3142618 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08542
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 435135: SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF EVENT WAS GENERATOR EXHAUSTED/BATTERY DEPLETION. IT WAS NOTED THAT THE ISSUE WAS RELATED TO HIGH SETTINGS. THE PATIENT EXPERIENCED NAUSEA AND VOMITING DUE TO THE EVENT. THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2013.THE PATIENT OUTCOME WAS NOTED AS NO INJURY. NO HOSPITALIZATION WAS REQUIRED. THE PATIENT HAD A FOLLOW UP ON (B)(6) 2013 AND SHE WAS ¿DOING MUCH BETTER.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY PLANNED TO REPLACE THE BATTERY ON (B)(6) 2013. THE BATTERY LASTED ONLY 1.5 YEARS. THE PATIENT WAS LOOKING FOR A HEALTHCARE PROVIDER WHO SPECIALIZED IN THEIR DEVICE. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243981 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention