PULSE GEN MODEL 1000
Report
- Report Number
- 1644487-2022-00857
- Event Type
- Malfunction
- Date Received
- July 15, 2022
- Date of Event
- June 7, 2022
- Report Date
- June 22, 2023
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- UDI-DI
- 05425025750405
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
- 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.
B5. DESCRIBE EVENT; CORRECTED INFORMATION ; INITIAL MDR INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION. H1. TYPE OF REPORTABLE EVENT; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION.
D6B. IF EXPLANTED, GIVE DATE; CORRECTED INFORMATION ; PRIOR MDR INADVERTENTLY INCLUDED INCORRECT INFORMATION KNOWN PRIOR TO SUBMISSION.
IT WAS REPORTED THAT AFTER COMPLETION OF BATTERY REPLACEMENT. ERROR CODE 14 WAS SEEN ON THE NEW GENERATOR. DIAGNOSTICS WERE RAN, AND SEEN TO BE OKAY. BATTERY LIFE WAS OK AS WELL. INTERROGATION WAS PERFORMED 2 WEEKS LATER AND NO ERROR CODE WAS SEEN. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
ERROR CODE 14 IS INDICATIVE OF THE DEVICE BEING PULSE DISABLED. THIS CAUSES THE GENERATOR TO RESET. ELECTROCAUTERY IS THE LIKELY CAUSE OF THIS RESET. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
PRODUCT ANALYSIS (PA) FOR THE GENERATOR WAS APPROVED. OTHER THAN THE NOTED EVENT (REBOOT DURING IMPLANT), THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REBOOT. 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 WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
IT WAS LATER REPORTED THAT THE BATTERY LIFE OF THE GENERATOR HAD SIGNIFICANTLY DROPPED. ADDITIONAL TABLET DATA WAS PROVIDED IN WHICH A DEPLETION EVENT LIKELY CAUSED BY ELECTROCAUTERY WAS CONFIRMED. THE PERCENT OF THE BATTERY LIFE CONSUMED DID NOT MATCH THE ACTUAL VOLTAGE READING FROM THE BATTERY. THIS SUDDEN VOLTAGE DROP IS AN EXPECTED EVENT WITH A BATTERY THAT REMAINS IMPLANTED IN A PATIENT AFTER BEING STRUCK BY ELECTROCAUTERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
IT WAS LATER REPORTED BY COMPANY REPRESENTATIVE THAT THE PATIENT DID NOT UNDERGO ANY OTHER SURGERY UNRELATED TO VNS, AND STATES THAT THE PATIENT WAS NEVER STRUCK BY ELECTROCAUTERY. THE DEVICE WAS REPORTED TO BE REPLACED. THE SUSPECT PRODUCT HAS NOT BEEN RETURNED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057340 | PULSE GEN MODEL 1000 | GENERATOR | LYJ | LIVANOVA USA, INC. | 1000 | 7144 | 05425025750405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male |