PULSE GEN MODEL 1000
Report
- Report Number
- 1644487-2024-01560
- Event Type
- Malfunction
- Date Received
- December 20, 2024
- Date of Event
- November 27, 2024
- Report Date
- May 12, 2025
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5, DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY SUBMITTED WITHOUT DEVICE HISTORY RECORDS. H6, ADVERSE EVENT PROBLEM CODES, CORRECTED DATA: INITIAL REPORT INADVERTENTLY SUBMITTED WITHOUT B14 CODE.
H6, CORRECTED DATA: SUPPLEMENTAL REPORT #3 INADVERTENTLY UPDATED C AND D CODING AND HAS BEEN UPDATED.
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.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
ADDITIONAL INFORMATION WAS RECEIVED THAT RAPID MAGNET SWIPES WERE ATTEMPTED TO UN-STICK THE REED SWITCH HOWEVER THIS WAS NOT SUCCESSFUL. A GENERATOR RESET WAS UNABLE TO BE PERFORMED, AND THE PATIENT'S SETTINGS WERE NOT ABLE TO BE ADJUSTED. THE PATIENT WILL UNDERGO A GENERATOR REPLACEMENT, HOWEVER THE REPLACEMENT HAS NOT OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.
THE SUSPECT DEVICE UNDERWENT PRODUCT ANALYSIS. THE INITIAL DATA DOWNLOAD SHOWS INDICATES AN OPEN REED SWITCH. THE INITIAL DATA DOWNLOAD SHOWS NO LOW IMPEDANCE HISTORY. THE LAST MAGNET SWIPE RECORDED WAS ON (B)(6) 2024, PRIOR TO EXPLANT. IN ADDITION, THE INITIAL DATA DOWNLOAD SHOWS OFTTIME, FURTHER INDICATING AN OPEN REED SWITCH. AN INTERROGATION AND A SYSTEM DIAGNOSTIC TEST WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PRODUCT ANALYSIS WORKSHEET WAS REVIEWED AND SHOWED NO ANOMALIES. WANDCOMM DATA WAS REVIEWED AND SHOWED NO ANOMALIES. DATA DUMP WAS REVIEWED AND SHOWED NO ANOMALIES. DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION.
IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS SEEN WITH LOW OUTPUT CURRENT (IMPEDANCE WAS NOTED TO BE WITHIN NORMAL LIMITS). WHEN THE OUTPUT CURRENT WAS LOWERED, THE LOW OUTPUT CURRENT MESSAGE PERSISTED. THE PATIENT NOTED THE MAGNET DOES NOT WORK AND CANNOT FEEL MAGNET STIMULATION. THE PHYSICIAN DID ATTEMPT TO PERFORM DIAGNOSTICS ON THE GENERATOR; HOWEVER AN ERROR CODE 254 WAS SEEN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2146316 | PULSE GEN MODEL 1000 | GENERATOR | LYJ | LIVANOVA USA, INC. | 1000 | 205711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |