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

Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Vomiting (2144); Hernia (2240); Cough (4457)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device was not available for physical evaluation.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the reporter or surgeon 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 could not be reviewed as the lot number was not provided.Limited investigation does not lead to a clear conclusion about the cause of the reported adverse event.Note: the company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided by the reporter.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided.Note: only the year for the implanted date was provided by the reporter.
Event or Problem Description
Ap small band was implanted in 2008.Around (b)(6) 2024, the patient had the band slip and was vomiting, cough and gerd.In (b)(6) 2024, the patient had the band revision (replaced) with an ap large band with the flex 2.0.During the revision/retrofit, a hiatal hernia was found and repaired.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: 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: maria quiroz ; 18 technology drive, suite 110; irvine, CA 92618 ; 8449377374
• MDR Report Key: 20589007
• Report Number: 3013508647-2024-00065
• Device Sequence Number: 8796951
• Product Code: LTI
• UDI-Device Identifier: 00850007764654
• UDI-Public: 00850007764654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female