BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEDISH ADJUSTABLE GASTRIC BAND

    MDR report key: 1556209 · Received December 8, 2009

    Report

    Report Number
    3005992282-2009-00363
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    January 1, 2007
    Report Date
    February 5, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. BAND WAS ADJUSTED AND LATER EXPLANTED. EVAL SUMMARY: THE TUBING AND THE SWEDISH ADJUSTABLE GASTRIC BAND (SAGB) BAND AND THE INJECTION PORT WERE RETURNED FOR ANALYSIS. VISUAL INSPECTION OF RETURNED DEVICE INDICATES THAT NO FAULT WAS FOUND IN THE BAND. FUNCTIONAL ANALYSIS WAS PERFORMED AND SUCCESSFUL RESULTS WERE OBTAINED FOR THE SWEDISH ADJUSTABLE GASTRIC BAND (SAGB). THE REPORTED EVENT WAS NOT CONFIRMED UPON VISUAL EXAM. THE PT PRESENTED WITH GASTROINTESTINAL REFLUX DISEASE (GERD), HAD THREE EPISODES OF ASPIRATION PNEUMONIA AND WAS DIAGNOSED WITH HIATAL HERNIA. REVIEW OF THE PRODUCTS INSTRUCTIONS FOR USE INDICATED THAT GASTROINTESTINAL REFLUX IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH ALL GASTRIC BANDING PROCEDURES. ALSO THE SWEDISH ADJUSTABLE GASTRIC BAND IS CONTRAINDICATED FOR BOTH GERD AND HIATAL HERNIA. ALTHOUGH GASTROINTESTINAL REFLUX IS AN ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING IT MUST ALSO BE CONSIDERED THAT THE OCCURRENCE OF GASTRIC REFLUX DISEASE, AND ASPIRATION PNEUMONIA ARE ALSO RECOGNIZED SYMPTOMS OF HIATAL HERNIA. WHILE IT'S NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING ROOT CAUSE IT MAY BE TENTATIVELY SUGGESTED THAT AN ASYMPTOMATIC HIATAL HERNIA MAY HAVE EXISTED PRIOR TO IMPLANTATION OF THE GASTRIC BAND. THE DISTAL RESTRICTION OF THE POUCH MAY HAVE CONTRIBUTED TO WORSENING SYMPTOMS OF THE HIATAL HERNIA. THE LOT# OF THE DEVICE WAS NOT COMMUNICATED; NO HISTORY DEVICE RECORDS COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED FOR CLINICAL STUDY THAT FOLLOWING LAPAROSCOPIC SAGB INSERTION, THE PT DEVELOPED GASTROESOPHAGEAL REFLUX DISEASE, AND HAD THREE EPISODES OF ASPIRATION PNEUMONIA (2007). THE PT PRESENTED TO THE ER IN 2007, WITH A DIAGNOSIS OF BILATERAL PNEUMONIA SECONDARY TO ASPIRATION. THE PT'S TREATMENT INCLUDED BAND ADJUSTMENT AND DRUG THERAPY. THE PT PRESENTED IN LATE OCT 2007, WITH INTRACTABLE GERD SYMPTOMS, INCLUDING NOCTURNAL REFLUX SYMPTOMS NOT HELPED BY FLUID REMOVAL FROM THE SAGB OR MEDICATIONS. THE PT UNDERWENT A LAPAROSCOPIC REPAIR OF A LARGE HIATAL HERNIA AND REPLACEMENT OF A NEW SAGB TWO MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEDISH ADJUSTABLE GASTRIC BAND LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R