MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BADING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Anemia (1706); Erosion (1750); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Scarring (2061); Seroma (2069); Vomiting (2144); Dizziness (2194); Regurgitation (2259)

Event Date 10/18/2014

Event Type  Injury  

Event Description

Pt reported that she almost died after implant with the lap-band system.The pt bled internally and had to get 5 units of blood and indicated that the lap-band system caused years of pain.The lap-band system was explanted; however, the pt continues to have problems due to the removal.Follow-up findings: pt reported "cord almost poking through skin" which physician "fixed." later "developed a seroma" and "cord and port were removed leaving the band around stomach." pt also reported "chronic indigestion, chronic nausea, vomiting, and serious pain." on an unk date the pt "began to feel faint passed out" and felt she "was going to fall over." "hemoglobin was 5 and had to get 5 units of blood." diagnostic testing showed "entire band had eroded through stomach" and "stomach was massively bleeding," which the physician tried to stop with medication and by burning but was unable." "blood pressure was dangerously low," and "when my hemoglobin was stable the physician removed the entire product." pt stated she has a "10 inch scar," was "in icu for many days," "out of work for 2 months," "don't think my stomach will ever be the same," and "have to take medication on a daily basis." the pt did not provide allergan permission to contact the physician.These events were not confirmed by a healthcare professional.

Manufacturer Narrative

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 explant date provided by the reporter and an approximate implant date of "ten years ago" 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.Hemorrhage, gastric erosion, anemia, hypotension, syncope, pain, seroma, vomiting, impaired lifestlye, dizziness, reflux, nausea, and hypertrophic scarring are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional info has been reported to allergan regarding the model number, serial number, event date, implant date, pt data or further event details.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BADING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4801012
• MDR Text Key: 5833997
• Report Number: 3006722112-2015-00059
• 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: Consumer
• Type of Report: Initial
• Report Date: 04/28/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAP-BAND ADJUSTABLE GASTRIC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/27/2015
• 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; Life Threatening; Required Intervention