BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3212159 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11469
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 435135, SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3116, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN REPLACED A 3116 IN THE PATIENT ON (B)(6) OF THIS YEAR. THE PATIENT WAS EXPERIENCING SOME PAIN SO TODAY (2013-(B)(6)) THE PHYSICIAN MOVED THE BATTERY TO A DIFFERENT LOCATION. THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311442 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention