1.5T LINX, 15B
Report
- Report Number
- 3008766073-2023-00066
- Event Type
- Injury
- Date Received
- April 17, 2023
- Date of Event
- January 26, 2023
- Report Date
- October 23, 2025
- Manufacturer
- TORAX MEDICAL, INC.
- Product Code
- LEI
- UDI-DI
- 00855106005356
- 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: 5/18/2023. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 28536, AND NO RELATED NONCONFORMANCES WERE IDENTIFIED.
(B)(4). DATE SENT: 3/31/2025. ADDITIONAL EVENT INFORMATION: AN ADVERSE EVENT HAS BEEN GENERATED. PLEASE REVIEW THIS EVENT AS SOON AS POSSIBLE. EVENT DETAILS START DATE: (B)(6) 2022 ALERT DATE: (B)(6) 2025 COUNTRY OF EVENT: US MODEL: LXMC15 DEVICE LOT NUMBER: 28536. DATE OF SURGERY: (B)(6) 2022. ADVERSE EVENT TERM: URINARY RETENTION. PATIENT DETAILS: PATIENT IDENTIFIER: (PLEASE REFER THE ATTACHED EMAIL) SITE COUNTRY NAME: UNITED STATES SEX: (PLEASE REFER THE ATTACHED EMAIL) AGE (AT TIME OF CONSENT): (PLEASE REFER THE ATTACHED EMAIL) ADDITIONAL EVENT DETAILS: SITE AWARENESS DATE: 17 MAR 2022 END DATE: (B)(6) 2022 SEVERITY: SEVERE IS THE ADVERSE EVENT SERIOUS? YES. DEATH: NO. DATE OF DEATH: BLANK. LIFE-THREATENING ILLNESS OR INJURY: NO. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES ADMISSION DATE: (B)(6) 2022 DISCHARGE DATE: (B)(6)2022 RESULTED IN MEDICAL OR SURGICAL INTERVENTION: NO LED TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE: BLANK RELATIONSHIP TO PRIMARY STUDY PROCEDURE: BLANK IF RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: INDEX INTERVENTION/TREATMENT: NONE: NO. DILATION PERFORMED: NO. INDICATE TYPE OF DILATION? BLANK. DATE OF DILATION: BLANK. DIAGNOSTIC INTERVENTION: NO. DIAGNOSTIC IMAGING: NO. DRUG THERAPY: NO. OBSERVATION: NO. LINX EXPLANT: NO. OTHER SURGICAL INTERVENTION: NO. OTHER INTERVENTION/TREATMENT: YES. IF OTHER SPECIFY: INDWELLING FOLEY PLACED WITH PLAN TO REMOVE WITH VOIDING TRIAL OUTPATIENT WITH UROLOGY. OUTCOME: RECOVERED/RESOLVED. ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: BLANK DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO. UPDATED. LOG LINE: 1. AWARENESS DATE: 03 APR 2023 = 26 JAN 2023.
(B)(4). LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION RECEIVED: PATIENT IDENTIFIER: (B)(6). (B)(6) MEDICAL CENTER SEX: FEMALE AGE (AT TIME OF CONSENT): 67 YEARS ALERT DATE: (B)(6) 2023 COUNTRY OF EVENT: US MODEL: LXMC15 DEVICE LOT NUMBER: 28536 DATE OF SURGERY: (B)(6) 2022 ADVERSE EVENT TERM: DYSPHAGIA REQUIRING TREATMENT ADDITIONAL EVENT DETAILS SITE AWARENESS DATE: (B)(6) 2023. END DATE:(B)(6) 2023. SEVERITY: MILD IS THE ADVERSE EVENT SERIOUS? NO. RELATIONSHIP TO STUDY DEVICE: CAUSAL RELATIONSHIP. INTERVENTION/TREATMENT: DILATION PERFORMED: YES. INDICATE TYPE OF DILATION? MECHANICAL. DATE OF DILATION: (B)(6) 2023. OUTCOME: RECOVERED/RESOLVED. ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: BLANK DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO. IF EVENT IS SERIOUS AND DEVICE RELATED, ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? : BLANK => N/A. ADVERSE EVENT TERM : DYSPHAGIA REQUIRING TREATMENT => DYSPHAGIA. 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: 4/23/2025. ADDITIONAL INFORMATION: RELATIONSHIP TO STUDY DEVICE: BLANK, NOT RELATED. ADMISSION DATE: 16 MAR 2022, 17 MAR 2022. RELATIONSHIP TO STUDY PROCEDURE: BLANK: PROBABLE.
(B)(4). DATE SENT: 5/9/2025 ADDITIONAL INFORMATION: IF OTHER, SPECIFY : INDWELLING FOLEY PPLACED WITH PLAN TO REMOVE WITH VOIDING TRIAL OUTPATIENT WITH UROLOGY INDWELLING FOLEY PLACED WITH PLAN TO REMOVE WITH VOIDING TRIAL OUTPATIENT WITH UROLOGY UPDATED LOG LINE: 2 UPDATED: IF EVENT IS SERIOUS AND DEVICE RELATED, ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? : BLANK N/A.
(B)(4). DATE SENT: 9/15/2025. ADDITIONAL EVENT INFORMATION. SEVERITY : MILD => MODERATE.
IT WAS REPORTED VIA CLINICAL TRIAL PATIENT TRX: (B)(6) EXPERIENCE, DYSPHAGIA REQUIRING TREATMENT. RELATIONSHIP TO STUDY DEVICE: CAUSAL RELATIONSHIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1819291 | 1.5T LINX, 15B | ANTI-REFLUX IMPLANT | LEI | TORAX MEDICAL, INC. | LXMC15 | 28536 | 00855106005356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Hospitalization| R |