MAUDE Adverse Event Report: ALLERGAN LAP-BAND APS; ADJUSTABLE GASTRIC BAND

Catalog Number B-2240

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Muscle Spasm(s) (1966); Pain (1994)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

Patient had adjustable gastric band placed in approx.11 years ago.Since then she has had several adjustments done but none during this past 5 years.Patient has been complaining of having pain in her pelvic area for the past five months and has stomach spasms that are random and not associated with anything.Procedure done approx.5 months ago: laparoscopic replacement of entire adjustable gastric band system, incision of cicatrix.Pre-op diagnosis: complication of gastric band procedure, morbid obesity.Post-op diagnosis: same as above.Findings: disconnected lap band catheter with end of catheter in pelvis.Not able to visualize pelvic structures due to excess omentum.Cicatrix incised along lesser curve lap-band was extracted in its entirety while slipping the new band through the old tract.

• Brand Name: LAP-BAND APS
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): ALLERGAN; 301 w howard ln ste 100; austin TX 78753
• MDR Report Key: 7769740
• MDR Text Key: 116656471
• Report Number: 7769740
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 118