BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1910058 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-09922
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    April 30, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    INFO RECEIVED FROM THE HEALTHCARE NOTED THAT THE PT DEVELOPED AN INCISIONAL HERNIA AT THE NEUROSTIMULATOR SITE. DURING REPAIR OF THE HERNIA, THE LEADS WERE DAMAGED AND HAD TO BE REPLACED. DEVICE PARAMETERS WERE NOTED AS 0.5 VOLTS, PULSE WIDTH OF 420 US AT A RATE OF 50 HZ (TIME ON: 4 SECONDS, TIME OFF: 1 SEC). IT WAS REPORTED THAT THE PT CONTINUED TO HAVE SYMPTOMS OF NAUSEA AND VOMITING AFTER THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MDT PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention EXPLANTED:| LEAD: MODEL 4351, LOT# NHT010185N| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT009959N