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

Model Number C-20360

Device Problems Leak/Splash (1354); Defective Device (2588); Contamination /Decontamination Problem (2895)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Pyrosis/Heartburn (1883); Nerve Damage (1979); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2020

Event Type  Injury  

Event Description

Information received by previous manufacturer (apollo endosurgery) in a uk manufacturer incident report (uk reference number: (b)(4)) in which patient states: "i have been suffering from abdominal pain dysmotility of the oesophagus bowel blockage chestpain breathing difficulties gerd" patient also states in 3.2f (remedial actions taken by healthcare facility, patient, or user subsequent to the incident: "recalled by fda for safety issues tissue damage rupture and leak mri dangers wording changed i am concerned with links to breast implants re silicone toxicity and lymphoma cancers due to overgrowth of scar tissue" no other relevant information was provided.

Manufacturer Narrative

Further information is expected from patient and associated healthcare providers.Codes specified in h6 health effect clinical code, health impact and h6: device problem codes are as reported from mhra mir report mir # ((b)(4)) and are being investigated pending further 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.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: maria jazmin quiroz ; 1001 calle amanener; san clemente, CA 92673 ; 8779377374
• MDR Report Key: 17020883
• MDR Text Key: 316131065
• Report Number: 3013508647-2023-00355
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2023

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?: Yes
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/30/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 140 KG