BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1841327 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00659
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    April 16, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. DEVICE ANALYSIS NOTED THE SHELL/RING AND BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE. ANALYSIS ALSO NOTES MISSING MATERIAL, PULLED MATERIAL, AND EVIDENCE OF CORING OF THE DAMAGED PORT SEPTUM LIKELY TO HAVE BEEN CAUSED BY THE USE OF A CORING NEEDLE. PUNCTURES AND DE-LAMINATION OF THE BELT OF THE BAND, DESCRIBED AS SURGICAL DAMAGE-LIKE, APPEARS TO BE DAMAGED BY A SURGICAL TOOL. THE TUBING APPEARS TO BE PULLED, CAUSING THE DELAMINATION/SEPARATION. EROSION AND PAIN ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ...ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN, AND...PORT SITE PAIN."

    Description of Event or Problem · 1

    ALLERGAN REP REC'D A VOICEMAIL MESSAGE FROM A HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE TO BE ABLE TO RETURN THE PRODUCT TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS REC'D BY ALLERGAN. EVENT DESCRIPTION STATES: "PT CAME IN WITH ABDOMINAL PAIN, [AND WAS] SENT FOR [AN] ESOPHAGRAM. RESULTS SHOWED EROSION. [THE] BAND/PORT WAS REMOVED AND REPLACED WITH A NEW ONE." NO INFO IF A REPLACEMENT WAS USED. THE DEVICE WAS RETURNED AND ANALYZED. THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE FROM THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention