BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3981562 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02187
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION: PREVIOUS TWO MEDWATCHES WERE SUBMITTED IN ERROR AS EVENTS WERE PREVIOUSLY REPORTED. MEDWATCHES ARE BEING REDACTED AS THEY WERE DUPLICATE MEDWATCHES OF THE FOLLOWING MANUFACTURING REPORTS: 6000032-2012-00150, 6000032-2012-00148, 2182207-2008-06713, AND 3004209178-2008-04926.

    Additional Manufacturer Narrative · 1

    NO ADDTIONAL INFORMATION. NOTIFY DATE SHOULD BE CHANGED FROM 2014-02-24 TO 2010-06-21.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PATIENTS HAD BOWEL OBSTRUCTION AND/OR PERFORATION OF THE BOWEL ASSOCIATED WITH THE LEADS. OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457148 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other