PULSE GEN MODEL 1000
Report
- Report Number
- 1644487-2025-00233
- Event Type
- Malfunction
- Date Received
- February 28, 2025
- Date of Event
- December 1, 2024
- Report Date
- December 17, 2025
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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.
IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED INCREASED EPILEPTIC ACTIVITY. PER THE PT.'S MOTHER SEIZURES HAVE INCREASED IN DURATION AND INTENSITY. SESSION REPORTS AND EXPORTED DATA WERE PROVIDED FOR REVIEW. REVIEW OF THE DATA SUGGESTS THAT THE GENERATOR'S REED SWITCH HAS LIKELY BECOME STUCK. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
THE SUSPECT DEVICE WAS RECEIVED FOR ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.
ADDITIONAL PROGRAMMING DATA WAS PROVIDED FOR REVIEW.
ADDITIONAL INFORMATION RECEIVED. PRODUCT ANALYSIS WAS COMPLETED AND REVIEWED. THE DATA FROM THE GENERATOR WAS ABLE TO CONFIRM REED SWITCH MALFUNCTION BUT THE TESTING OF THE ACTUAL GENERATOR COULD NOT CONFIRM REED SWITCH MALFUNCTION. BASED ON THE INFORMATION PROVIDED, REED SWITCH MALFUNCTION WAS SEEN DURING THE IMPLANT, HOWEVER, THE REED SWITCH LIKELY BECAME UNSTUCK DURING EXPLANT AND OR TRANSPORTATION BACK TO THE MANUFACTURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
UPDATE WAS RECEIVED THAT THE GENERATOR WAS REPLACED. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031284 | PULSE GEN MODEL 1000 | GENERATOR | LYJ | LIVANOVA USA, INC. | 1000 | 897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Unknown |