BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2930098 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00983
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    December 13, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. FINAL DEVICE ANALYSIS OF THE LEAD ((B)(4)) REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE PRODUCT WAS SEGMENTED/CUT THROUGH THE BODY DURING EXPLANT. FINAL DEVICE ANALYSIS OF THE LEAD ((B)(4)) REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE PRODUCT WAS SEGMENTED/CUT THROUGH THE BODY DURING EXPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS REMOVED DUE TO BOWEL OBSTRUCTION. IT WAS NOTED THAT A PATIENT WITH A PRIOR HISTORY OF TOTAL COLECTOMY FOR INERTIA AND SUBSEQUENT GASTRIC IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROPARESIS HAD A SMALL BOWEL OBSTRUCTION. IT WAS REPORTED THAT THE PATIENT FAILED CONSERVATIVE TREATMENT AND LAPAROSCOPIC EXPLORATION REVEALED MULTIPLE LOOPS OF THE SMALL INTESTINE WERE ENTANGLED WITH THE DEVICE LEADS. THERE WAS EVIDENCE OF CHRONICITY AND THEY WERE UNABLE TO REDUCE THE OBSTRUCTION WITHOUT DIVIDING THE LEADS. THE LEADS AND INS WERE REMOVED, RESOLVING THE BOWEL OBSTRUCTION. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35028 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention