BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2904633 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00363
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 18, 2012
    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

    PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AS WELL AS A LOSS OF STIMULATION OR THERAPEUTIC EFFECT. AS A RESULT, THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND TWO LEADS WERE EXPLANTED AND REPLACED WITH AN ENTIRELY NEW SYSTEM. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED 10 DAYS LATER INDICATED THAT THE PATIENT HAD SUCCESSFUL THERAPY AND APPEARED TO BE DOING WELL. IT WAS NOTED THAT SO FAR THE ISSUES HAD BEEN RESOLVED WITH THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11177 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention