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

Device Problem Device Slipped (1584)

Patient Problems Sepsis (2067); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported by the patient that the lap band got slipped and the patient experienced serious adverse event.Per report, the patient had the gastric band in 2014.The patient stated that the gastric band slipped and twisted.The patient also stated the gastric band did not help patient losing weight.No additional information was provided.

Manufacturer Narrative

Attempts to contact the patient for additional information were made; however, the patient refused to provide more information.No information available regarding the product that was involved.Multiple attempts to obtain additional information for an investigation were unsuccessful.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 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 for review.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 would be available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.Section d6a, only the year was provided.

Manufacturer Narrative

Reporting additional information that patient posted additional information on facebook.No additional information is available as the patient requests no contact from reshape.

Event Description

Additional information reported by patient on facebook on (b)(6) 2023.Patient stated that the lap-band twisted and made her go septic and almost died.No additional information was availalbe as the patient requested no further contact.

Manufacturer Narrative

Attempts to contact the patient for additional information were made; however, the patient refused to provide more information.Section d6a, only the month and year was provided.

Event Description

Additional informaiton reported by patient on facebook on 24feb23.Patient stated that the lap-band was implanted in (b)(6) 2014 and lost 140 pounds but started gaining weight back.The band was removed under emergency surgery because in the reporters's words, "the lap band had twisted".A sleeve gastrectomy was performed on (b)(6) 2016 and the patient reported losing 253 lbs and maintained weight at 180-183 at time of report.No additional information was availalbe as the patient requested no further contact.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: toan hoang ; 1001 calle amanecer; san clemente, CA 92673 ; 9492764349
• MDR Report Key: 16280885
• MDR Text Key: 308606475
• Report Number: 3013508647-2023-00003
• 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,Followup,Followup
• Report Date: 03/13/2023

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 Operator: Health Professional
• Initial Date Manufacturer Received: 01/02/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/02/2023; 01/02/2023
• Supplement Dates FDA Received: 03/09/2023; 03/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention; Other