MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYS (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

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

Patient Problem Renal Failure (2041)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Company rep reported that the pt went into "kidney failure" after implant surgery.The device remains implanted and explant surgery has not been scheduled at this time.The event has not been confirmed by the doctor.

Manufacturer Narrative

The product associated with this report has not been returned as the device was not explanted.Based on the implant date provided by the reporter the connector type is assumed to be a taper ii.The reporter of the event was asked to return the product for analysis, if it is explanted in the future.The surgery has not occurred, so allergan has not received the device nor performed analysis at this time.Further information from the report regarding event, product, or pt details has been requested.No additional information is available at this time.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYS (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNK ALLERGAN; 71 south los carneros road; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3784156
• MDR Text Key: 4376880
• Report Number: 2024601-2014-00204
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P00008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• 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