LEAD MODEL 303
Report
- Report Number
- 1644487-2022-00698
- Event Type
- Malfunction
- Date Received
- June 13, 2022
- Date of Event
- February 5, 2022
- Report Date
- February 2, 2023
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- UDI-DI
- 05425025750115
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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.
SUPPLEMENTAL #1 FAILED DUE TO A ¿DUPLICATE REPORT¿, THEREFORE THIS SUPPLEMENTAL REPORT IS A DUPLICATE OF SUPPLEMENTAL #1 REPORT TO ENSURE THE INFORMATION IS SUCCESSFULLY SUBMITTED TO THE FDA. A ¿PASSED¿ ACKNOWLEDGEMENT WAS NOT RECEIVED FROM THE FDA FOR SUPPLEMENTAL #1 DUE TO THE ESG OUTAGE THAT OCCURRED BETWEEN ON (B)(6) 2023.
IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE. X-RAY SHOWED NOTHING EXPLICIT AND SO A SURGICAL INTERVENTION PROCEEDED. DURING SURGERY THE HIGH IMPEDANCE WAS CONSISTENT AFTER RE-INSERTING AND CHECKING THE PORT CONNECTION. A NEW GENERATOR WAS TRIED AND HIGH IMPEDANCE WAS STILL RECORDED. THE DECISION WAS MADE TO REVISE THE LEAD AND WAS IMPLANTED SUCCESSFULLY WITH AN IMPEDANCE READING WITHIN NORMAL LIMITS. SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. X-RAYS HAVE NOT BEEN REVIEWED BY MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
IT WAS LATER REPORTED THE EXPLANTED PRODUCTS WERE RECEIVED INTO PRODUCT ANALYSIS. PRODUCT ANALYSIS (PA) FOR THE GENERATOR WAS COMPLETED. THE VISUAL OBSERVATIONS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. AN INTERROGATION AND SYSTEM DIAGNOSTIC TESTS WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED A LOW BATTERY CONDITION. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION AND A BATTERY LIFE CALCULATION WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. LEAD PRODUCT ANALYSIS WAS ALSO COMPLETED. THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS DUE TO FRACTURE OF LEAD(S), WHICH WAS CONFIRMED IN ANALYSIS. DURING THE VISUAL ANALYSIS, A PIN COIL BREAK MATE WERE OBSERVED NEAR THE ANCHOR TETHER. THE COIL ENDS WERE DARK AND PITTED. DUE TO THE CONDITION OF THE COIL ENDS, THE FRACTURE MECHANISM COULD NOT BE ASCERTAINED. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED DURING THE FUNCTIONAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. FIVE SETS OF SETSCREW MARKS WERE OBSERVED ON THE CONNECTOR PIN. THE MARKS PROVIDE EVIDENCE OF A PROPER MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF BOTH THE GENERATOR AND CONNECTOR PIN, THEREBY ENSURING A GOOD ELECTRICAL CONNECTION TO THE LEAD AT ONE POINT IN TIME. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
IT WAS LATER REPORTED THE EXPLANTED PRODUCTS WERE RECEIVED INTO PRODUCT ANALYSIS. PRODUCT ANALYSIS (PA) FOR THE GENERATOR WAS COMPLETED. THE VISUAL OBSERVATIONS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. AN INTERROGATION AND SYSTEM DIAGNOSTIC TESTS WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED A LOW BATTERY CONDITION. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION AND A BATTERY LIFE CALCULATION WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. LEAD PRODUCT ANALYSIS WAS ALSO COMPLETED. THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS DUE TO FRACTURE OF LEAD(S), WHICH WAS CONFIRMED IN ANALYSIS. DURING THE VISUAL ANALYSIS, A PIN COIL BREAK & BREAK MATE WERE OBSERVED NEAR THE ANCHOR TETHER. THE COIL ENDS WERE DARK AND PITTED. DUE TO THE CONDITION OF THE COIL ENDS, THE FRACTURE MECHANISM COULD NOT BE ASCERTAINED. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED DURING THE FUNCTIONAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. FIVE SETS OF SETSCREW MARKS WERE OBSERVED ON THE CONNECTOR PIN. THE MARKS PROVIDE EVIDENCE OF A PROPER MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF BOTH THE GENERATOR AND CONNECTOR PIN, THEREBY ENSURING A GOOD ELECTRICAL CONNECTION TO THE LEAD AT ONE POINT IN TIME. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1365557 | LEAD MODEL 303 | LEAD | LYJ | LIVANOVA USA, INC. | 303-20 | 204107 | 05425025750115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Male |