BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 16994552 · Received May 24, 2023

    Report

    Report Number
    3013508647-2023-00369
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    September 13, 2019
    Report Date
    May 24, 2023
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING, AND AS ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE MADE. AT THIS TIME, THE REPORTED ISSUE WILL BE TRACKED AND TRENDED. D6A: STUDY EXAMINED ERODED BANDS IMPLANTED BETWEEN OCTOBER 1995 AND JANUARY 2019, BUT DIDN'T IDENTIFY EXACT DATES FOR THE 3697 IMPLANTED DEVICES. D6B: STUDY EXAMINED EXPLANTED DEVICES FROM 2009 THROUGH 2019 BUT DIDN'T IDENTIFY DATES OF EXPLANT FOR THE 94 EXPLANTED DEVICES.

    Description of Event or Problem · 0

    LITERATURE REVIEW PERFORMED: TECHNICAL DETAILS AND RESULT OF A MINIMALLY INVASIVE MANAGEMENT OF GASTRIC BAND EROSIONS: A SERIES OF 47 PATIENTS. (B)(6) (1), (B)(6) (2), (B)(6) 3), (B)(6) (2), (B)(6) (2). 1 - GENERAL SURGERY, DEPARTMENT OF SURGERY, UNIVERSITY OF PISA, VIA PARADISA 2, 56124 PISA, ITALY. 2 - GENERAL AND LAPAROSCOPIC SURGERY, (B)(6) CLINIC, (B)(6) ITALY. 3 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, (B)(6) ITALY. OBESITY SURGERY 29, 3754-3761 (2019). HTTPS://DOI.ORG/10.1007/S11695-019-04170-2 PUBLISHED ONLINE: 13 SEP 2019. THIS PUBLISHED ARTICLE DESCRIBED A SINGLE-CENTER RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED DATABASE TO IDENTIFY PATIENTS WHO UNDERWENT LAGB REMOVAL FROM 2009 TO 2019 DUE TO BAND EROSION. THE AIM OF THE STUDY WAS TO DESCRIBE THE TECHNICAL DETAILS OF THE CENTER'S LAPAROSCOPIC MANAGEMENT OF BAND EROSION. AN ORIGINAL TECHNIQUE FIT FOR THE MOST WIDESPREAD LAP-BAND AP (ADVANCED PLATFORM) SYSTEM (ALLERGAN, IRVIN, CA) REOPENING CHARACTERISTICS WAS PROPOSED, AND INDICATIONS, PERIOPERATIVE, AND LATE OUTCOMES OF THE PROCEDURE WERE EVALUATED. A TOTAL OF 94 PATIENTS UNDERWENT LAGB REMOVAL DURING THE STUDY PERIOD, AMONG WHOM 22 (16.7%) PATIENTS WERE DIAGNOSED WITH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508853 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O