BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4086058 · Received September 12, 2014

    Report

    Report Number
    3007566237-2014-02571
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    December 18, 2003
    Report Date
    January 6, 2004
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: SAME EVENT REPORTED IN MANUFACTURER REPORT # 6000032-2013-00127. FILES BEING MERGED. HOWEVER, REPORT IS NOT BEING REDACTED AS THIS REPORT STILL CONTAINED INFORMATION THAT WAS NOT PREVIOUSLY REPORTED IN REPORT # 6000032-2013-00127. ANY ADDITIONAL INFORMATION RECEIVED WILL BE UPDATED IN SUPPLEMENTAL REPORTS OF 6000032-2013-00127.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF IMPROVEMENT IN SYMPTOMS. AN X-RAY WAS TAKEN AND SHOWED THAT ONE OF THE LEADS WAS DISLODGED AND SUGGESTED THAT THERE WAS A LEAD BREAKAGE. AS A RESULT, THE TWO LEADS WERE PLANNED TO BE REPLACED. THE PREOPERATIVE DIAGNOSES INCLUDED GASTROPARESIS, DIABETES, AND POSSIBLE ELECTRODE BREAKAGE. THE OPERATION CONSISTED OF EXPLORATORY LAPAROTOMY, REMOVAL OF THE PREVIOUSLY PLACED LEADS BY CUTTING THEM, AND PLACEMENT OF TWO NEW LEADS. IT WAS STATED THAT THE POSTOPERATIVE DIAGNOSIS WAS LEAD FRACTURE NOTING THAT THE PROXIMAL LEAD WAS "BROKEN" AND HAD "PULLED OUT OF THE STOMACH." THE PROCEDURE WAS PERFORMED "WITHOUT COMPLICATION" AND THE FINAL DIAGNOSIS WAS "GASTROPARESIS" AND "NONFUNCTIONAL GASTRIC PACEMAKER." THE EVENT ENDED ON (B)(6) 2003 AS THE PATIENT RECOVERED FROM THE EVENT WITH THERAPEUTIC ACTION. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED. ANY ADDITIONAL INFORMATION RECEIVED WILL RESULT IN A NEW REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564291 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention