MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-2240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Fever (1858); Neurological Deficit/Dysfunction (1982); Pain (1994); Vomiting (2144); Ulcer (2274)

Event Date 01/24/2014

Event Type  Injury  

Event Description

Patient reported removal of "eroded lap-band due to "continuous vomiting, stomach hurt, chest pain, left shoulder pain", "liquid making its way outside of stomach", "could drink very little without hurting", "infection", "fever and severe pain", "huge ulcer", "after 14 hours still had a lot of food in stomach", and physician "informed" patient they "had vagus nerve damage from the band erosion".Prior to explant the patient was treated with medication for "infection" and patient is being treated currently with medication.These events have not been confirmed by a healthcare professional.

Manufacturer Narrative

(b)(4).Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the catalog number, implant date and explant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done."erosion", "ulcer", "infection", "pain", "vomiting", "fever", "liquid intolerance," and "vagus nerve damage" are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the serial number, the event date, patient data or further event details.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zona franca
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4914774
• MDR Text Key: 20062742
• Report Number: 3006722112-2015-00207
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Type of Report: Initial
• Report Date: 06/17/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/13/2015
• 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): Hospitalization; Required Intervention