BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3981751 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02189
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    June 21, 2010
    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: INITIAL REPORT IS BEING REDACTED - INITIAL REPORT SHOULD NOT HAVE BEEN FILED AS IT REPORTED EVENTS THAT WERE PREVIOUSLY REPORTED IN MANUFACTURING REPORT NUMBERS: 3004209178200700000 6000033200200955 2950887200802347 2182207200801988 2182207200501110 3004209178200805717.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX PATIENTS HAD BOWEL OBSTRUCTION AND/OR PERFORATION OF THE BOWEL ASSOCIATED WITH THE LEADS. ADDITIONALLY, THE PATIENTS HAD NECROSIS. EVENTS REQUIRED SURGICAL INTERVENTION AND THE PATIENTS RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458038 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R