MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Catalog Number LXC14

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2018.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported that the patient had a magnetic sphincter augmentation device implanted for medically refractory gastroesophageal reflux.It was reported a reoccurrences of heartburn symptoms (moderate intensity).The follow-up egd that took place (b)(6) 2018 - impression that linx slipped onto the cardia of the stomach.Per dr.(b)(6), he doesn¿t believe it is definitive the device has moved.The device was removed on (b)(6) 2019 and a toupet fundoplication was done.The patient was discharged after a 33-hour hospital stay.

Manufacturer Narrative

(b)(4).Additional information was received: lxc14, lot 4477.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot 4477 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information was received: interventions taken: office/clinic visit ((b)(6) 2018), egd ((b)(6) 2018), dilation ((b)(6) 2018), explant ((b)(6) 2019), surgical intervention ((b)(6) 2019).09may2019 update: reviewing the discharge note, all 14 beads were removed, and the subject was converted to a partial fundoplication.

• Brand Name: LXC14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8599645
• MDR Text Key: 144712869
• Report Number: 3008766073-2019-00340
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2019

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 Expiration Date: 03/05/2017
• Device Catalogue Number: LXC14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/23/2019; 05/14/2019; 08/20/2019
• Supplement Dates FDA Received: 05/14/2019; 06/10/2019; 09/16/2019
• Patient Sequence Number: 1
• Patient Age: 74 YR