InjuryQJN

LINX

Received Oct 23, 2020 · Event occurred Sep 1, 2020

Report MW5097436 · MDR key 10733232

Device

Generic name

Laparoscopic Accessories, Esophageal Sizing

Manufacturer

Johnson & Johnson /ethicon Endo-surgery, Inc.

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

Nonstandard Device
Detachment of Device or Device Component

Patient

56 YR

Failure of Implant
Failure of Implant

Narrative

Description of Event or Problem

TORAX ETHICON (WAS TORAX) LINX ANTI REFLUX DEVICE IMPLANTED (B)(6) 2016. RECEIVED RECALL NOTICE 9/2018. GERD RETURNED (B)(6) 2020. LINX IMPLANT CONFIRMED SEPARATED (B)(6) 2020 (BARIUM SWALLOW). HAVE CONTACTED ETHICON BUT NO REPLY YET. FDA SAFETY REPORT ID # (B)(4).