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 Problems Abdominal Pain (1685); Fatigue (1849); Muscle Weakness (1967)

Event Date 07/13/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain and weakness leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation occurred in (b)(6) 2018 at (b)(6) by dr.(b)(6).-patient returned to physician complaining of pain and weakness such that she could not perform her duties at work.-patient took two weeks leave from work and returned to the physician several weeks later stating she was too weak to work.-patient received a dilation as dysphagia was a potential cause for the patient's chest pain.-dr.(b)(6) did not believe the patient's symptoms were related to the linx device or procedure.-patient attended physical therapy, and the source of weakness could not be determined.-dr.(b)(6) recommended patient see a doctor specializing in neuromuscular disorders.-patient was in the emergency room for over 14 hours on one occasion.-symptoms progressed causing the patient to resign from work.-patient saw surgeon at (b)(6) (dr.(b)(6)) who suspected a titanium allergy.No formal allergy testing was performed.-dr.(b)(6) reports that the patient began using a wheelchair due to progressive worsening of weakness and fatigue.-device explant due to pain and weakness occurred on (b)(6) 2018 at (b)(6) by dr.(b)(6).The device was cultured with results "negative to date" as of 08/01/2018.-device was found in the correct position/geometry.

Manufacturer Narrative

Updated device position at implant and patient status post implant.Updated with device analysis results.Updated for device return information.Updated follow up number.Updated for additional information checkbox.(b)(4).Updated report date.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain and weakness leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred in (b)(6) 2018 at (b)(6) center by dr.(b)(6).Patient returned to physician complaining of pain and weakness such that she could not perform her duties at work.Patient took two weeks leave from work and returned to the physician several weeks later stating she was too weak to work.Patient received a dilation as dysphagia was a potential cause for the patient's chest pain.Dr.(b)(6) did not believe the patient's symptoms were related to the linx device or procedure.Patient attended physical therapy, and the source of weakness could not be determined.Dr.(b)(6) recommended patient see a doctor specializing in neuromuscular disorders.Patient was in the emergency room for over 14 hours on one occasion.Symptoms progressed causing the patient to resign from work.Patient saw surgeon at the (b)(6) (dr.(b)(6)) who suspected a titanium allergy.No formal allergy testing was performed.Dr.(b)(6) reports that the patient began using a wheelchair due to progressive worsening of weakness and fatigue.Device explant due to pain and weakness occurred on (b)(6) 2018 at (b)(6) by dr.(b)(6).The device was cultured with results "negative to date" as of (b)(6) 2018.Device was found in the correct position/geometry.Patient reported on (b)(6) 2018 that "within hours after having the linx out i started feeling better and am starting to get some strength back." patient is reported on (b)(6) 2018 as "making slow but steady progress".

• 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
• MDR Report Key: 7759343
• MDR Text Key: 116371372
• Report Number: 3008766073-2018-00128
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/29/2021
• Device Model Number: LXMC14
• Device Lot Number: 17506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 26 YR