BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 20729653 · Received November 19, 2024

    Report

    Report Number
    3013508647-2024-00069
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    June 7, 2024
    Report Date
    February 10, 2025
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    UDI-DI
    00850007764654
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A LETTER WAS RECEIVED FROM FDA MEDWATCH PROGRAM WITH REPORT # MW5162807; THE REPORT WAS REVIEWED IT AND WAS DISCOVERED THAT THIS REPORT IS THE SAME AS THE MW515979 REPORT SENT TO APOLLO ENDOSURGERY, INC. ON (B)(6) 2024. WE CONSIDER THIS A DUPLICATE REPORT AND WILL NOT DOCUMENT IT AS A NEW COMPLAINT. CONSEQUENTLY, A NEW MDR WILL NOT BE SUBMITTED. A RESPONSE WAS SENT TO FDA WITH THE EXPLANATION IN (B)(6), 2024.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT AVAILABLE FOR PHYSICAL EVALUATION. THE INVESTIGATION INVOLVED COMMUNICATION VIA EMAIL WITH THE REPORTER TO CLARIFY THE DESCRIPTION OF THE EVENT, AND THE ANALYSIS OF RELEVANT INFORMATION PROVIDED IN VIEW OF SUPPORTING THE IDENTIFICATION OF POSSIBLE CAUSES FOR THE ADVERSE EVENT. THE INVESTIGATION INVOLVED THE ANALYSYS OF THE LOT HISTORY RECORDS OF THE LAP-BAND DEVICE INVOLVED. LOT HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES OR NON-CONFORMANCE'S WERE RECORDED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. NO NEW RISKS IDENTIFIED, THE CURRENT RISK IS IDENTIFIED WITH A LOW RATE OF OCCURRENCE FOR THE REPORTED COMPLAINT CATEGORIES. NO CORRECTION OR CORRECTIVE ACTION REQUIRED. LIMITED INVESTIGATION DOES NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 0

    REPORT # MW5162807 WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE REPORT RECEIVED IS A DUPLICATE OF REPORT # MW5159479. THE PATIENT PRESENTED WITH MILD EPIGASTRIC PAIN AND REFLUX AND UPPER ENDOSCOPY WAS PERFORMED, WHICH REVEALED ERODED LAP-BAND AND LAP BAND REMOVAL WAS RECOMMENDED. LAP BAND WAS FOUND PENETRATING IN THE CARDIA ON THE GREATER CURVE SIDE. NO INFLAMMATION WAS REALLY NOTED. THE SURGEON CUT THE LAP BAND INTO PIECES TO REMOVE AND ONE WAS LEFT BEHIND, WHICH THEY HAD TO GO BACK TO RETRIEVE.

    Description of Event or Problem · 0

    REPORT, (MW5159479) WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE PATIENT PRESENTED WITH MILD EPIGASTRIC PAIN AND REFLUX AND UPPER ENDOSCOPY WAS PERFORMED, WHICH REVEALED ERODED LAP-BAND AND LAP BAND REMOVAL WAS RECOMMENDED. LAP BAND WAS FOUND PENETRATING IN THE CARDIA ON THE GREATER CURVE SIDE. NO INFLAMMATION WAS REALLY NOTED. THE SURGEON CUT THE LAP BAND INTO PIECES TO REMOVE AND ONE WAS LEFT BEHIND, WHICH THEY HAD TO GO BACK TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314066 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES 75EA2685 00850007764654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention