1.5T LINX, 14B
Report
- Report Number
- 3008766073-2025-00073
- Event Type
- Injury
- Date Received
- June 11, 2025
- Date of Event
- January 1, 2025
- Report Date
- July 22, 2025
- Manufacturer
- TORAX MEDICAL, INC.
- Product Code
- LEI
- UDI-DI
- 855106005349
- PMA / PMN Number
- P100049
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 6/16/2025. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE DATE OF IMPLANT? (B)(6) 2017. 14 BEAD IMPLANT. WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. PLEASE SEND TO: [email protected] IMAGES COMING IN SEPARATE EMAIL. THERE WILL BE TWO WHAT IS THE DEVICE LOT NUMBER? 13077 CATALOGS # LXMC14 EXP 12/02/20 IMPLANTED IN ESOPHAGUS WHEN WAS THE DATE OF EXPLANT? (B)(6) 2025. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? REFLUX. DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? YES, OF SPINE (B)(6) 2023 IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? NO INFO ON STRENGTH. WHAT WAS ANATOMICAL POSITION OF THE MRI? MRI OF SPINE AND LUMBAR WITHOUT NO INFO ON POSITION. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? UPPER GI WITH CONTRAST ONLY ENDOSCOPY (B)(6) 2025 NO DILATION PLACED BRAVO CAPSULE TO MONITOR REFLUX 78 DEEMESTER SCORE. DID THE PATIENT RECEIVE ANY DILATIONS WHILE THE LINX WAS IMPLANTED? NO WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? UPPER GI DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? N/A WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES. WHAT IS THE MANAGEMENT PLAN? LINX REMOVED PERFORMED PARTIAL GASTRECTOMY WITH GASTROJEJUNOSTOMY. IS DEVICE REMOVAL SCHEDULED? HAS BEEN EXPLANTED. IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? WHEN AND IF THE EXPLANATION TAKES PLACE CAN WE ASK THAT THE PROCEDURE GETS VIDEO RECORDED AND THE VIDEO SHARED? NO VIDEOS. WHEN AND IF THE LINX DEVICE IS REMOVED, MAY WE ASK THAT THE DEVICE BE RETURNED FOR ANALYSIS? WE HAVE REQUESTED A SHIPPING BOX TO BE SENT TO (B)(6). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 13077, AND NO NON-CONFORMANCES WERE IDENTIFIED.
(B)(4). DATE SENT: 6/17/2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 13077, AND NO NON-CONFORMANCES WERE IDENTIFIED. PHOTO ANALYSIS: AN X-RAY IMAGE OF THE DEVICE IN VIVO WAS REVIEWED BY A MEDICAL SAFETY OFFICER. AS PER MEDICAL SAFETY OFFICER: DISCONTINUOUS DEVICE. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE MECHANISM/CAUSE OF FAILURE IS UNKNOWN AS A HANDS-ON ANALYSIS OF THE DEVICE IS NECESSARY TO DETERMINE THE CAUSE OF FAILURE. NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS POINT.
(B)(4). DATE SENT 7/9/2025. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
(B)(4). DATE SENT: 6/11/2025. B3: ONLY EVENT YEAR KNOWN: 2025. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHAT WAS THE DATE OF IMPLANT? WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. PLEASE SEND TO: [email protected] WHAT IS THE DEVICE LOT NUMBER? WHEN WAS THE DATE OF EXPLANT? WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? WHAT WAS ANATOMICAL POSITION OF THE MRI? DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? DID THE PATIENT RECEIVE ANY DILATIONS WHILE THE LINX WAS IMPLANTED? WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES. WHAT IS THE MANAGEMENT PLAN? IS DEVICE REMOVAL SCHEDULED? IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? WHEN AND IF THE EXPLANATION TAKES PLACE CAN WE ASK THAT THE PROCEDURE GETS VIDEO RECORDED AND THE VIDEO SHARED? WHEN AND IF THE LINX DEVICE IS REMOVED, MAY WE ASK THAT THE DEVICE BE RETURNED FOR ANALYSIS? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
(B)(4). DATE SENT 7/17/2025. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
(B)(4). DATE SENT: 7/22/2025. INVESTIGATION SUMMARY: A LINX DEVICE WITH A VISIBLE TWO WELD BALLS THAT DISCONNECTED FROM A WASHER WAS RETURNED TO THE ANALYSIS SITE. THE LINK LENGTH AND TENSILE FORCE MEASUREMENTS WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS DURING DEVICE ANALYSIS. THE REMAINING DEVICE CHARACTERISTICS, EXCEPTING THE VISIBLE WELD BALL, SHOW NO ANOMALIES FOR A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. THE DEVICE WAS SCANNED USING COMPUTER TOMOGRAPHY (CT), OPTICAL MICROSCOPY, AND SCANNING ELECTRON MICROSCOPY. THE WASHER THROUGH-HOLE 1 AT THE SEPARATION WERE MEASURED AND WAS GREATER THAN THE SPECIFICATION. THE WASHER THROUGH-HOLE WAS CONCENTRIC WITH AMOUNT OF MATERIAL DISPLACEMENT AT THE OUTER EDGE OF THE THROUGH HOLE. THE OVERALL APPEARANCE OF THE SURFACE OF THE WASHER THROUGH HOLE DIDN¿T EXHIBIT GROSS LOSS OF SHAPE. THE TOP VIEW OF THE DIAMETER OF THE EXPOSED WELD BALL 1 WAS MEASURED. THIS DIAMETER IS WITHIN THE SPECIFICATION. THE WELD BALL WAS CONCENTRIC WITH THE RESPECT TO THE WIRE. THE WASHER THROUGH-HOLE 2 AT THE SEPARATION WERE MEASURED AND WAS GREATER THAN THE SPECIFICATION. THE WASHER THROUGH-HOLE WAS CONCENTRIC WITH AMOUNT OF MATERIAL DISPLACEMENT AT THE OUTER EDGE OF THE THROUGH HOLE. THE OVERALL APPEARANCE OF THE SURFACE OF THE WASHER THROUGH HOLE DIDN¿T EXHIBIT GROSS LOSS OF SHAPE. THE TOP VIEW OF THE DIAMETER OF THE EXPOSED WELD BALL 2 WAS MEASURED. THIS DIAMETER IS WITHIN THE SPECIFICATION. THE WELD BALL WAS CONCENTRIC WITH THE RESPECT TO THE WIRE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION.
IT WAS REPORTED THAT THE PATIENT BEGAN HIS VISIT ABOUT 3 YEARS AGO FOR A HEART BURN. THE LINX WAS ALREADY IN PLACE, BUT IT STOPPED WORKING. THE LINX WAS BROKEN INTO TWO PIECES, WHICH WERE ABLE TO BE EXTRACTED WITH NO MAJOR ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85523 | 1.5T LINX, 14B | ANTI-REFLUX IMPLANT | LEI | TORAX MEDICAL, INC. | 13077 | 855106005349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |