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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Hernia (2240)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number was provided therefore a device history could not be done.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The patient underwent surgery, the operative report provided indicates patient had linx device implanted on (b)(6) 2018.Surgeon notes in the explant report on 5/14/2020 that the patient had a disruption of the linx device and recurrent gerd.The surgeon noted, ¿the linx was herniated on the left.The buckle was noted to be intact but the wire was fractured just to the left of the buckle.¿ the surgeon also stated, ¿patient was explicit that he wanted the linx device replaced and not a fundoplication¿.The device was replaced with another 15 bead linx device.¿.

Manufacturer Narrative

(b)(4).Date sent: 5/7/2021.Upon review it was identified that this is a duplicate report.All reported information for this event was reported under 3008766073-2020-00090.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11731172
• MDR Text Key: 247480583
• Report Number: 3008766073-2021-00077
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR