LEAD MODEL 304
Report
- Report Number
- 1644487-2025-00196
- Event Type
- Injury
- Date Received
- February 21, 2025
- Date of Event
- January 22, 2025
- Report Date
- May 30, 2025
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- UDI-DI
- 05425025750139
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 117
Narratives
LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.
B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT NOTE THAT THE PATIENT WAS EXPERIENCING AIRWAY ISSUES. B6 RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT OUT RELEVANT INFORMATION. F10 ADVERSE EVENT PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT OUT CODE E0717.
IT WAS REPORTED THAT THE PATIENT DEVELOPED ACUTE VOICE HOARSENESS/DYSPHONIA AROUND (B)(6) 2025. THE PATIENT WAS SEEN BY AN ENT AND THEY FOUND A COMPLETELY PALSIED LEFT VOCAL FOLD AND WERE WONDERING ABOUT NEUROPRAXIA INJURY CAUSING THE DYSPHONIA. THERE IS NO HEMATOMA ON CT. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT'S DEVICE WAS TURNED OFF FOR A FEW DAYS AND THEN THE HOARSENESS RESOLVED AND THEIR VOICE RETURNED TO NORMAL. THE DEVICE HAS SINCE BEEN TURNED BACK ON AT LOWER SETTINGS AND THERE HASN'T BEEN ANY HOARSENESS. IT IS BELIEVED THAT THE PATIENT'S NERVE WAS STILL SWOLLEN AFTER UNDERGOING SURGERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THE CAUSE OF THE AIRWAY ISSUES WERE ASSESSED TO BE RECURRENT ANGIOEDEMA FLARE (MOST LIKELY FROM MISSED MAINTENANCE MEDS & SUPERFICIAL INFECTIONS TO CHEST/NECK INCISIONS AND HANDS). THE CHEST AND NECK INCISIONS WERE SUPERFICIAL INFECTIONS THAT DID NOT MAKE CONTACT WITH THE VNS HARDWARE AS PER THE ULTRASOUND AND CT SCANS. THE PATIENT DIDN'T EXPERIENCE ANY LARYNGEAL NERVE INJURY OR HOARSENESS WITH THIS ADMISSION AND THE IMPEDANCE WAS WITHIN NORMAL LIMITS. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR AND LEAD PERFORMED. THE GENERATOR AND LEAD WERE CONFIRMED TO HAVE BEEN HP STERILIZED PRIOR TO DISTRIBUTION INTO THE FIELD. THE DEVICES PASSED ALL SPECIFICATIONS.
ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT IS BACK HAVING AIRWAY ISSUES BUT HER VOICE IS STILL GOOD AND THEIR IMPEDANCE IS WITHIN NORMAL LIMITS.
ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT IS STILL IN THE HOSPITAL AND THE CAUSE REMAINS UNKNOWN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
THE REPORTED INFECTIONS WERE ASSESSED TO BE RELATED TO THE PATIENT'S COMPLEX AUTOIMMUNE CONDITION AND A RESULTS OF SKIN ORGANISMS MIGRATING INTO THE WOUND WHICH IS A RISK WITH ANY SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1692902 | LEAD MODEL 304 | LEAD | LYJ | LIVANOVA USA, INC. | 304-20 | 206313 | 05425025750139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female | Disability| H |