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

Device Problem Insufficient Information (3190)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

This information was posted on social media.Additional information was provided by the complainant and attempts to contact the surgeon 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.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.

Event Description

Complainant stated in a social media post , customer reply "same" to another post " "i had to have my lap band removed started causing major health issues" also poster provided additional information "when my lap, bama's first put in a complaint of pain in my chest, that radiated up into my shoulder and down my left arm.I was told it was due to swelling and that overtime it would go away.After numerous complaints if it's still hurting me, i have a cat being told that i was over eating when i was barely eating anything at all, and i would get the pain in my chest, going up into my shoulder and down my arm.I finally found a surgeon who removed for me thank god.That pain went away as soon as my body healed from the surgery from the removal.It was definitely placed incorrectly".No other relevant information was provided.

• 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: maria quiroz ; 18 technology drive, suite 110; irvine, CA 92618 ; 8449377374
• MDR Report Key: 18279624
• MDR Text Key: 329890184
• Report Number: 3013508647-2023-00587
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2023

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
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/06/2023
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female