MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number LXMC14

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/11/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced symptoms that, according to the patient's doctor, varied "from time to time" leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure and device implant on (b)(6) 2015.Egd with gastroesophageal balloon dilation conducted (b)(6) 2016 for mild dysphagia; patient reported dysphagia (score 3 of 5 on demeester scale) prior to anti-reflux procedure.Uneventful device explant (b)(6) 2016.Linx device found in the correct position/geometry.

Manufacturer Narrative

Per an email from dr.(b)(6) on (b)(6) 2016 the patient's dysphagia (patient stated reason for explant) has resolved.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced symptoms that, according to the patient's doctor, varied "from time to time" leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure and device implant on (b)(6) 2015.Egd with gastroesophageal balloon dilation conducted (b)(6) 2016 for mild dysphagia; patient reported dysphagia (score 3 of 5 on demeester scale) prior to anti-reflux procedure.Uneventful device explant (b)(6) 2016.Linx device found in the correct position/geometry.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 5645238
• MDR Text Key: 44886524
• Report Number: 3008766073-2016-00035
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

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: Physician
• Device Model Number: LXMC14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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; Other
• Patient Age: 41 YR
• Patient Weight: 84