BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3090377 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07227
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 16, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE TURNED SIDEWAYS AND TRIED TO COME THROUGH THE SKIN. IT WAS NOTED THAT THE PATIENT'S PHYSICIAN WAS "JUST GOING TO MAKE IT FLUSH WITH THE SKIN, BUT SCAR TISSUE HAD BUILT UP SO MUCH THAT IT BROKE IT OFF." THE DEVICE ENDED UP BEING REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNCLEAR, BUT IT WAS LIKELY AN INFECTION OR CELLULITIS. THERE WERE NO SYMPTOMS REPORTED ASIDE FROM THE PROTRUSION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). A CT SCAN HAD SHOWN MALPOSTIONING OF THE INS BATTERY. IT WAS NOTED THAT WHILE EXPLORING THE INS BATTERY SITE, ONE LEAD WAS INADVERTENTLY DAMAGED BY DISSECTION AND HAD TO BE REPLACED ALONG WITH THE INS. THE REPORTER STATED THAT THE PATIENT HAD REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT BUT HAD RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191741 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention