MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Additional information: the device was implanted on (b)(6) 2015.The patient presented with reoccurrence of gerd symptoms, heartburn in (b)(6) 2018.A chest x-ray was taken on (b)(6) 2018 and discontinuous linx device was confirmed.Explant on (b)(6) 2018.Implanted new device (b)(6) 2018.Lxmc16.Lot 20395 from hospital¿s inventory.

Event Description

It was reported that an explant will take place due to the patient presented with reoccurring reflux.Chest xray showed discontinuous linx device.

Manufacturer Narrative

(b)(4).Device analysis: visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.The remaining device characteristics show no anomalies for a device that has been reasonably changed as part of the explant procedure.Analysis found that the returned device had an exposed weld ball visible paired with the washer side of the adjacent bead.The washer through hole was measured with computed tomography (ct) and found to out of specification.The paired weld ball diameter was found to meet specifications.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.As the device was tested to 250g tensile force in production, it is presumed that a certain geometric combination of the weld ball and the washer hole resulted in the device separation in vivo.The dhr for lot 8775 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8220450
• MDR Text Key: 132206302
• Report Number: 3008766073-2019-00231
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2019
• Device Catalogue Number: LXMC15
• Device Lot Number: 8775
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 03/12/2019
• Patient Sequence Number: 1