PULSE GEN MODEL 103
Report
- Report Number
- 1644487-2024-01448
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- August 16, 2024
- Report Date
- May 2, 2025
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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.
THE GENERATOR WAS RETURNED DUE TO AN UNKNOWN REASON AND PRODUCT ANALYSIS WAS COMPLETED. THE DUT WOULD NOT INTERROGATE AND WAS OPENED AS USUAL WITH INITIAL CUTS. WHILE TEARING ALONG THE SEAM WELD, FLUID WAS SEEN INSIDE THE CAN. THE FEEDTHROUGH AREA OF THE HEADER WAS EXAMINED FOR EVIDENCE OF A BREACH AND NONE BREACH WAS IDENTIFED. THE HEADER WAS REMOVED AND THE FEEDTHROUGH WAS EXAMINED MORE CLOSELY AND NOTHING WAS SEEN. THE INSIDE OF THE FEEDTHROUGH WAS EXAMINED AND RESIDUE WAS SEEN ON THE FEEDTHROUGH ON THE INSIDE OF THE CAN. CORROSION WAS SEEN ON THE PCBA DUE TO THE UNKNOWN FLUID. THE WELD SEAM WAS REMOVED AND EXAMINED FOR PINHOLES, BUT NOTHING WAS CONCLUDED VISUALLY. BOTH CASE HALVES WERE EXAMINED FOR EVIDENCE OF A BREACH IN THE INTEGRITY OF THE METAL AND NOTHING WAS SEEN. BOTH CASE HALVES WERE EXAMINED VIA SEM. NO BREACH IN THE CASE OR SEAM WELD WAS SEEN. THE GOLD BRAZING AROUND THE FEEDTHROUGH WAS EXAMINED VIA SEM AND A VOID WAS SEEN, BUT IT IS UNKNOWN WHETHER THE VOID EXTENDS ALONG THE LENGTH OF THE FEEDTHROUGH WIRE TO THE INSIDE OF THE CAN. THE WHITE DEPOSITS WERE EXAMINED VIA SEM AND EDS AND SHOWED PEAKS OF CARBON, SODIUM, CHLORINE, AND LEAD. THE THIN FILM DEPOSIT WAS ALSO EXAMINED VIA SEM AND SHOWED PEAKS OF CARBON, OXYGEN, AND TIN. THE DENDRITIC GROWTH WAS EXAMINED VIA SEM AND SHOWED PEAKS OF LEAD, CARBON, OXYGEN, SODIUM, AND TIN. THE ORIGIN OF THE ELEMENTS SEEN OR TIMING OF THEIR INGRESS INTO THE ASSEMBLY COULD NOT BE DETERMINED. BATTERY VOLTAGE WAS MEASURED AND CONFIRMED AN EOS CONDITION. THE DUT WAS NON-FUNCTIONAL DUE TO THE CORROSION CAUSED BY THE UNKNOWN FLUID. THE DHR OF THE DEVICE WAS REVIEWED AND SHOWED NO ANOMALIES OR DEFECTS. ALL MANUFACTURING STEPS WERE COMPLETED AND MET REQUIREMENTS INCLUDING THE LEAK TEST, HELIUM LEAK TEST, VACUUM BAKE, AND CASE WELDING OPERATIONS. THE PASSING OF THE LEAK TESTS DURING MANUFACTURING INDICATE THAT THE SEAM WELD WAS LIKELY NOT THE ROOT CAUSE OF THE ISSUE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICE WAS EXPLANTED DUE TO PATIENT DEATH. THE PATIENT'S DEATH WAS NOTED TO BE DUE TO SUDEP AND NOT IN ANY WAY RELATED TO VNS THERAPY AND AS OF THE PATIENT'S LAST FOLLOW UP ON (B)(6) 2022, NO DEVICE MALFUNCTIONS WERE NOTED.
ADDITIONAL VENDOR ANALYSIS WAS COMPLETED ON THE BATTERY. NO VISUAL ANOMALIES WERE NOTED. EXTERNAL CELL SURFACE WAS INSPECTED AND NO DEFECTIVE CONDITIONS WERE SEEN. OPEN CIRCUIT VOLTAGE WAS MEASURED AT ROOM TEMP AND MID-CELL THICKNESS WAS OBTAINED. X-RAY ANALYSIS WAS PERFORMED AND NO DEFECTS WERE SEEN. DEVICE HISTORY AND ELECTRICAL BURN-IN RECORDS WERE REVIEWED. NO ABNORMAL OR DEFECTIVE CONDITIONS WERE NOTED DURING THE MANUFACTURE OF THE CELL AND MET SPECIFICATIONS FOR SHIPMENT. MICROCALORIMETRY AND COMPLEX IMPEDANCE SPECTROSCOPY WAS UNABLE TO BE PERFORMED DUE TO NEGATIVE VOLTAGE. ELECTRICAL TESTING WAS NOT PERFORMED DUE TO THE ADVANCED STATE OF DEPLETION. THE CATHODE AND ANODE SEPARATORS WERE THOROUGHLY INSPECTED TWICE AND NO DISTORTIONS OF THE ANODE OR CATHODE WERE SEEN. ALL WELDS WERE SATISFACTORY. THE GLASS TO METAL SEAL WITH INSPECTED AND A PARTICLE WAS OBSERVED ON THE FERRULE WALL EDGE UNDER THE ELASTOMETER. THE PARTICLE WAS SENT FOR SEM/EDS ANALYSIS AND NO FOREIGN ELEMENTS TO THE BATTERY COMPONENTS WERE SEEN AND THE PARTICLE IS BELIEVED TO BE GLASS. THE PRESENCE OF THE PARTICLE IS NOT CONSIDERED TO BE CONTRIBUTORY TO THE DEPLETED CONDITION OF THE BATTERY. THE HEADER ASSEMBLY PASSED THE HE LEAK TESTING. NO OTHER DEFECTS OUTSIDE OF THE PREVIOUSLY REPORTED GLASS PARTICLE WERE IDENTIFIED THAT WOULD ACCOUNT FOR PREMATURE DEPLETION AND NO DEFICIENCIES WERE SEEN. ADDITIONAL VENDOR ANALYSIS WAS ALSO COMPLETED ON THE FEED THROUGH ASSEMBLY. X-RAY CT WAS PERFORMED AND DID NOT SHOW ANY FEATURES THAT WOULD ACCOUNT FOR HERMETICITY FAILURE. DUE TO THE IRREGULARITY OF THE REMAINING ENCLOSURE FOLLOWING EXTRACTION OF THE FFT FROM THE DEVICE, HERMETICITY TESTING COULD NOT BE PERFORMED TO VERIFY THE PRESENCE OF A LEAK PATH IN THE FFT. EXTERNAL EXAMINATION OF THE FFT SHOWED NECKING OF THE LEAD WIRES AND CONTACT DAMAGE ON THE SURFACE OF THE ACCOMPANYING GOLD BRAZE SURFACE. TYPICAL BRAZES AT THE TWO LEAD WIRES WERE SEEN WITH NO INDICATION OF ANY CONDITIONS THAT WOULD RESULT IN A LEAK PATH OF THE FFT. DYE PENETRANT WAS APPLIED TO INTERNAL SURFACES OF THE FFT AND WAS MONITORED FOR TRANSFER OF DYE FOR 48 HOURS. NO DYE PENETRANT WAS FOUND ON THE EXTERNAL SURFACES OF THE FFT. HIGH MAGNIFICATION EXAMINATION OF THE GOLD BRAZE SURFACES SHOWED TYPICAL SURFACE MORPHOLOGY AND BRAZE FILLET FORMATION. THE FFT WAS SONICALLY CLEANED IN ACETONE AND DRIED. DYE PENETRANT WAS REAPPLIED TO THE INTERNAL SURFACES AND MONITORED FOR AN ADDITIONAL 48 HOURS. THE ISSUE WAS UNCONFIRMED.
ADDITIONAL PRODUCT ANALYSIS OF THE GENERATOR WAS PERFORMED AND SHOWED THAT FOLLOWING CT, NO FEATURES SUCH AS BRAZE VOIDS WERE SEEN THAT WOULD ACCOUNT FOR A HERMICITY FAILURE. DUE TO THE IRREGULARITY OF THE REMAINING ENCLOSURE, HERMICITY TESTING COULD NOT BE PERFORMED TO VERIFY THE PRESENCE OF A LEAK PATH IN THE FFT. EXTERNAL EXAMINATION OF THE FFT SHOWED NECKING OF THE LEAD WIRES AND CONTACT DAMAGE ON THE SURFACE OF THE ACCOMPANYING GOLD BRAZE SURFACE. THE EXTERNAL EXAMINATION FOUND TYPICAL BRAZES AT THE TWO LEAD WIRES AND AT THE OD OF THE INSULATOR WITH N O INDICATION OF ANY CONDITIONS THAT WOULD RESULT IN A LEAK PATH AT THE FFT. DYE PENETRANT WAS APPLIED TO THE INTERNAL SURFACE OF THE FFT AND WAS MONITORED FOR TRANSFER TO THE EXTERNAL SURFACES FOR 48 HOURS. NO DYE PENETRANT WAS FOUND ON THE EXTERIOR OF THE FFT AND HIGH MAGNIFICATION EXAMINATION SHOWED TYPICAL MORPHOLOGY AND BRAZE FILLET FORMATION. NO LEAKS WERE IDENTIFIED. VENDOR ANALYSIS OF THE BATTERY AND ORGANIC ANALYSIS IS STILL UNDERWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2421752 | PULSE GEN MODEL 103 | GENERATOR | LYJ | LIVANOVA USA, INC. | 103 | 2751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male |