MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Pyrosis/Heartburn (1883); Lymphoma (3263)

Event Type  Injury  

Event Description

Complainant stated, "reporter called to report that her gastric lap band was implanted approximately thirteen years ago (2011), and it has been causing her multiple health and medical issues since then.She is experiencing shortness of breath, swallowing problems, gastro-esophageal reflux disease (gerd), joint problems and not feeling well overall.Reporter also stated that in the same period of time she has had nonhodgkin's lymphoma where, there is no family history of any of the illnesses as listed above and that she was very healthy prior.Reporter stated that she is upset that before surgery, her doctor told her that there is less than a 1% chance of complications with this device but has recently learned that there is a 50% chance of complications with the device.Additionally, reporter was told that the lap band is a device that would last her a life time where, she learned that it has a 7 to 10 year lifespan and her lap band is now 13 years old.She was never contacted by the manufacturer or her healthcare professional(s) about any of this information.Reporter states that now she will need to have additional surgery to have it removed.".No other relevant information was provided.

Manufacturer Narrative

Attempts to contact the poster to follow-up or obtain additional information were unsuccessful and thus, the company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided in the post.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided, as is.No information is available regarding the product that was involved, the authenticity of the complainant, or the veracity of the information provided by the complainant.Lapband dfu contains the rates of adverse events where the overall rate is listed as (b)(4) and aligns with the information reportedly provided by the surgeon.The lifetime of the lapband is minimum 20 years per test report (b)(4).The surgeon's contact information was not provided and the reported event of misinformation could not be confirmed.Unable to determine if the complaint is about the lap-band or about another band which was available in the us and phased out at the end of 2016.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the patient responds with more information.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.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.If additional information becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.Complaint initially reported by allergan.Mdr report # mw5145608.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer Contact: robert banner ; 18 technology drive, suite 110; irvine, CA 92618 ; 8779377374
• MDR Report Key: 18000088
• MDR Text Key: 326446874
• Report Number: 3013508647-2023-00563
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other