1.5T LINX, 14B
Report
- Report Number
- 3008766073-2021-00145
- Event Type
- Injury
- Date Received
- July 28, 2021
- Date of Event
- July 9, 2021
- Report Date
- October 9, 2025
- Manufacturer
- TORAX MEDICAL, INC.
- Product Code
- LEI
- UDI-DI
- 00855106005349
- PMA / PMN Number
- P100049
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 8/23/2021. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THE DHR FOR LOT 26971 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND.
(B)(4). DATE SENT: 10/29/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THERE WAS A DEVICE EXPLANT ON THE (B)(6) THAT IS ENTERED IN THE DATABASE. THE CRA INSTRUCTED THE SITE TO SEND IN THE PAPER COMPLAINT REPORTING FORM FOR THIS EXPLANT LAST WEEK. WE¿RE ALSO REPORTING VIA EMAIL BECAUSE WE ARE REPORTING THESE WITH THE FORM PER CHU POLICY AND VIA ALERTS/EMAIL. INABILITY TO SWALLOW, PARTICIPANT HAD ANXIETY ABOUT IMPLANT. EXPLANT WAS LAPAROSCOPIC.
(B)(4); DATE SENT: 4/4/2022. ADDITIONAL INFORMATION RECEIVED: PARTICIPANT HAD ANXIETY ABOUT IMPLANT: NO. DESCRIBE ANY NOTABLE OBSERVATIONS DURING THE EXPLANT PROCEDURE: THICK CAPSULE. SURROUNDING LINX CAPSULE DENSELY ADHERENT TO UNDERSURFACE OF LEFT LIVER LOBE.
(B)(4); DATE SENT: 4/20/2022. ADDITIONAL INFORMATION PROVIDED: UNABLE TO SWALLOW AFTER LINX PLACEMENT. NO CHANGE AFTER DILATION X2. SYMPTOMS MAY BE RELATED TO A NEUROLOGIC DISORDER UNDIAGNOSED PRIOR TO LINX IMPLANTATION. PARTICIPANT HAD ANXIETY ABOUT IMPLANT : NO => YES. PARTICIPANT HAD ANXIETY ABOUT IMPLANT : YES => NO. DESCRIBE THE TECHNIQUE USED FOR EXPLANT (CHECK ALL THAT APPLY):LAPAROSCOPIC : YES => NO.
(B)(4). DATE SENT: 8/20/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD WE PLEASE OBTAIN A COPY OF THE DIAGNOSTIC IMAGE(S)? NO. WHAT IS THE NAME OF THE HOSPITAL FACILITY? GENERAL SURGERY ASSOCIATES, INC WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? NO ANSWER. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? NO ANSWER. WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 WHEN DID THE PATIENT GET DISCHARGED? NO ANSWER. WHAT IS THE CURRENT STATUS OF THE PATIENT? SHE HAS BEEN DISCHARGED FROM THE HOSPITAL.
(B)(4) DATE SENT: 2/5/2024 ADDITIONAL INFORMATION RECEIVED: DIAGNOSTIC IMAGING : YES => NO DILATION PERFORMED : YES => NO OBSERVATION : YES => NO INDICATE TYPE OF DILATION? : MECHANICAL => BLANK UPDATED LOG LINE 2: IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO : BLANK => INDEX DATE OF DILATION : BLANK => (B)(6) 2021 OBSERVATION : YES => NO UPDATED LOG LINE 3: IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO : EXPLANT => BLANK UPDATED LOG LINE 3: ADVERSE EVENT TERM : DYSPHAGIA 2 WEEKS AFTER LINX EXPLANTATION => DYSPHAGIA 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? : YES => N/A UPDATED LOG LINE 3: RELATIONSHIP TO STUDY PROCEDURE : POSSIBLE => NOT RELATED RELATIONSHIP TO STUDY DEVICE : CAUSAL RELATIONSHIP => NOT RELATED INACTIVATED LOG LINE 3 NEW LOG LINE 4: EVENT DETAILS START DATE: (B)(6) 2021 ALERT DATE: (B)(6) 2024 COUNTRY OF EVENT: US MODEL: LXMC14 DEVICE LOT NUMBER: 26971 DATE OF SURGERY: (B)(6) 2021 ADVERSE EVENT TERM: DYSPHAGIA PATIENT DETAILS PATIENT IDENTIFIER: (B)(6) SEX: FEMALE AGE (AT TIME OF CONSENT): 47 YEARS ADDITIONAL EVENT DETAILS SITE AWARENESS DATE: (B)(6) 2021 END DATE: (B)(6) 2021 SEVERITY: MILD IS THE ADVERSE EVENT SERIOUS? NO 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: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK 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: CAUSAL RELATIONSHIP RELATIONSHIP TO PRIMARY STUDY PROCEDURE: CAUSAL RELATIONSHIP 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: YES LINX EXPLANT: YES OTHER SURGICAL INTERVENTION: NO OTHER INTERVENTION/TREATMENT: NO IF OTHER SPECIFY: BLANK OUTCOME: RECOVERED/RESOLVED ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: NO DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO UPDATED LOG LINE 4: 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? : NO => N/A NEW LOG LINE 5: EVENT DETAILS START DATE: (B)(6) 2021 ALERT DATE: (B)(6) 2024 COUNTRY OF EVENT: US MODEL: LXMC14 DEVICE LOT NUMBER: 26971 DATE OF SURGERY: (B)(6) 2021 ADVERSE EVENT TERM: ODYNOPHAGIA PATIENT DETAILS PATIENT IDENTIFIER: (B)(6) SEX: FEMALE AGE (AT TIME OF CONSENT): 47 YEARS ADDITIONAL EVENT DETAILS SITE AWARENESS DATE: (B)(6) 2021 END DATE: (B)(6) 2021 SEVERITY: MODERATE IS THE ADVERSE EVENT SERIOUS? NO 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: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK 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: CAUSAL RELATIONSHIP RELATIONSHIP TO PRIMARY STUDY PROCEDURE: CAUSAL RELATIONSHIP 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: YES LINX EXPLANT: YES OTHER SURGICAL INTERVENTION: NO OTHER INTERVENTION/TREATMENT: NO IF OTHER SPECIFY: BLANK OUTCOME: RECOVERED/RESOLVED ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: N/A DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO UPDATED LOG LINE 5: DATE OF DILATION : BLANK => (B)(6) 2021 DILATION PERFORMED : NO => YES INDICATE TYPE OF DILATION? : BLANK => MECHANICAL UPDATED EXPLANT NOTIFICATION: IF YES, CHOOSE THE PRIMARY AE LOG LINE, START DATE AND TERM: : #005 (B)(6) 2021-ODYNOPHAGIA => BLANK UPDATED EXPLANT NOTIFICATION: IF YES, CHOOSE THE PRIMARY AE LOG LINE, START DATE AND TERM: : #001 (B)(6) 2021-INABILITY TO SWALLOW => #005 (B)(6) 2021-ODYNOPHAGIA WAS THE LINX EXPLANT A RESULT OF AN ADVERSE EVENT PER PROTOCOL DEFINITIONS? : YES => NO.
(B)(4), DATE SENT: 5/13/2024. ADDITIONAL INFORMATION RECEIVED: UPDATED EXPLANT NOTIFICATION. IF YES, CHOOSE THE PRIMARY AE LOG LINE, START DATE AND TERM: BLANK => #004, 17SEP2021-DYSPHAGIA. WAS THE LINX EXPLANT A RESULT OF AN ADVERSE EVENT PER PROTOCOL DEFINITIONS? : NO/YES, EXPLANT SUBJECT.
(B)(4). EVENT DATE UNKNOWN; CAPTURED AS AWARENESS DATE. ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT WAS READMITTED TO THE HOSPITAL FOR INABILITY TO SWALLOW AND DEHYDRATION 10 DAYS AFTER SURGERY. I HAD NOT SEEN HER FOR HER FIRST POST OPERATIVE FOLLOW UP VISIT. SHE WAS TREATED WITH HYDRATION AND IV METHYLPREDNISOLONE 40 MG IV TWICE DAILY. HER SWALLOWING IMPROVED IN 36 HOURS AND SHE WAS DISCHARGED HOME ON A SOFT DIET AND PREDNISONE 20 MG DAILY FOR AN ADDITIONAL 5 DAYS. ALL MEDICATIONS WERE PRESCRIBED BY ME. ESOPHAGRAM WAS PERFORMED AND THE LINX DEVICE IS IN THE PROPER LOCATION AND THERE WAS NO IMPACTED FOOD. PROBLEM SEEMED TO BE RELATED TO POST OPERATIVE SWELLING. ADDITIONAL INFORMATION WAS OBTAINED: WHAT WAS THE MEDICAL TREATMENT YOU RECEIVED? HOSPITAL ADMINISTRATION. WAS THE ¿MEDICAL TREATMENT¿ JUST A SCHEDULE POST-SURGICAL FOLLOW UP? NO. IF THE MEDICAL TREATMENT WAS MEDICATION, WAS THE MEDICATION DOCTOR PRESCRIBED? YES. WAS THE MEDICATION ONLY OVER THE COUNTER MEDICATION? NO. ADDITIONAL INFORMATION RECEIVED: LXMC14, LOT # 26971, DATE OF SURGERY: (B)(6) 2021, FEMALE, (B)(6) YEARS OLD AT TIME OF CONSENT. ISSUE: INABILITY TO SWALLOW. REQUIRED IN-PATIENT HOSPITALIZATION. ADMITTED ON (B)(6) 2021. DISCHARGED ON (B)(6) 2021. NO DILATION WAS PERFORMED. DIAGNOSTIC IMAGING DONE. DRUG THERAPY PRESCRIBED. PATIENT IS STILL PART OF THE STUDY. ADDITIONAL INFORMATION RECEIVED: ADMISSION DATE: (B)(6) 2021, INABILITY TO SWALLOW, NO DISCHARGE DATE PROVIDED. 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. 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.
IT WAS REPORTED THE PATIENT EXPERIENCE, DIFFICULTY SWALLOWING. THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1133852 | 1.5T LINX, 14B | ANTI-REFLUX IMPLANT | LEI | TORAX MEDICAL, INC. | LXMC14 | 26971 | 00855106005349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Required Intervention |