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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

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APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10CM; ADJUSTABLE GASTRIC BAND Back to Search Results
Model Number 10CM
Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2015
Event Type  Injury  
Manufacturer Narrative
Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.The reporter stated the device was discarded, and did not have any further information on the device such as serial or catalog number.Without the device or additional device information, the connecter type associated with this event cannot be determined.Device labeling addresses possible outcomes of leakage as follows: adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.
 
Event Description
Reported as: the patient reported to their physician they heard a "pop" and lost restriction of their lap-band system 3 months ago.When the physician went to replace the band, they found that it was leaking at the belt/inner seam juncture.The entire lap-band system was removed and replaced.
 
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Brand Name
LAP-BAND SYSTEM 10CM
Type of Device
ADJUSTABLE GASTRIC BAND
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s capitol of texas hwy
bldg 1, ste 300
austin TX 78746
Manufacturer (Section G)
ALLERGAN
global park free zone
900 global park
la aurora de heredia, costa rica
CS  
Manufacturer Contact
laura leboeuf
1120 s capitol of texas hwy
bldg 1, ste 300
austin, TX 78746
5122795141
MDR Report Key5311735
MDR Text Key33907043
Report Number3006722112-2015-00587
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/19/2015
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 Physician
Device Model Number10CM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/19/2015
Initial Date FDA Received12/18/2015
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 Number1
Treatment
GABAPENTIN
Patient Outcome(s) Required Intervention;
Patient Age36 YR
Patient Weight100
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