BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5440785 · Received February 17, 2016

    Report

    Report Number
    3008766073-2016-00011
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 19, 2016
    Report Date
    June 20, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005134
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CONTACTED TORAX MEDICAL REGARDING CONTINUED MODERATE DYSPHAGIA SYMPTOMS. DISCUSSIONS WITH THE PATIENT REVEALED THAT THE PATIENT HAS REFUSED PHYSICIAN RECOMMENDED DILATIONS TO TREAT HER POST-EXPLANT DYSPHAGIA SYMPTOMS. THE PATIENT ACKNOWLEDGED THAT PRIOR TO DEVICE EXPLANT SHE HAD ACUTE RELIEF OF DYSPHAGIA SYMPTOMS WHEN DILATED. THE PATIENT WAS ENCOURAGED BY TORAX MEDICAL TO REENGAGE HER PHYSICIAN REGARDING HER SYMPTOMS AND POTENTIAL TREATMENTS.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. GASTROESOPHAGEAL BALLOON DILATION ATTEMPTED IN (B)(6) 2015 TO ADDRESS POST-PROCEDURAL MODERATE DYSPHAGIA DID NOT ALLEVIATE SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. GASTROESOPHAGEAL BALLOON DILATION ATTEMPTED IN (B)(6) 2015 TO ADDRESS POST-PROCEDURAL MODERATE DYSPHAGIA DID NOT ALLEVIATE SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98768 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXC12 5928 00855106005134

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| S