PULSE GEN MODEL 1000
Report
- Report Number
- 1644487-2022-00977
- Event Type
- Malfunction
- Date Received
- August 12, 2022
- Date of Event
- July 18, 2022
- Report Date
- April 17, 2023
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- UDI-DI
- 05425025750405
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- 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 UPON INTERROGATION, THERE WAS A LOW OUTPUT STATUS WARNING. THEY WAS UNABLE TO RUN DIAGNOSTICS. THEY CHANGED THE PULSE WIDTH SETTING. THE LEAD IMPEDANCE AND BATTERY LIFE WERE FINE UPON INTERROGATION. HE NOTED ERROR CODE 254 CAME UP AS WELL. IT WAS UNKNOWN IF PATIENT WAS ABLE TO FEEL NORMAL OR MAGNET STIMULATION. THE INTERNAL DATA WAS REVIEWED AND IT WAS DETERMINED THAT THE PATIENT WAS IN A STIM INHIBITED STATE DURING INTERROGATION, INDICATING THAT THE REED SWITCH OF THE GENERATOR WAS CLOSED EVEN THOUGH A MAGNET WAS NOT PRESENT. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. INTERNAL INVESTIGATION INTO SIMILAR EVENTS WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF REED SWITCH FAILURES. THE PRIMARY ROOT CAUSE IS BELIEVED TO BE REED SWITCHES STICKING IN THE CLOSED POSITION AFTER EXTENDED EXPOSURE TO MAGNETIC FIELDS. THE INVESTIGATION ALSO IDENTIFIED RESIDUAL MAGNETIC PROPERTIES OF THE GENERATOR BATTERY TO BE A POTENTIAL CONTRIBUTOR; HOWEVER, TESTING PERFORMED DURING THE INVESTIGATION FOUND THE EFFECT TO BE HIGHLY VARIABLE WITH EACH MAGNETIC FIELD EXPOSURE AND ANY CLOSURE OF THE REED SWITCH IMPACTED BY THIS PHENOMENON WOULD LIKELY BE REVERSED BY SUBSEQUENT SWIPING OF THE PATIENT MAGNET. THUS, THE MOST LIKELY CONTRIBUTOR OF THE IDENTIFIED COMPLAINTS IS CONSIDERED TO BE MECHANICAL STICKING OF THE REED SWITCH BLADES. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.
IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN AGAIN IN CLINIC. THE PATIENT'S DEVICE WAS DISABLED.
IT WAS REPORTED THAT PATIENT HAD A RESET SEEN ON THEIR GENERATOR IN CLINIC. THE GENERATOR DATA WAS SENT IN AND REVIEWED FOR THE KNOWN REED SWITCH MALFUNCTION, BUT UPON REVIEW, AN UNEXPECTED RESET ERROR CODE 6 WAS ALSO FOUND. ALTHOUGH THIS DEVICE ALSO HAS EXPERIENCED A STUCK CLOSED REED SWITCH, AT THIS TIME THIS IS BELIEVED TO BE COINCIDENTAL AS OTHER DEVICES HAVE HAD THIS SAME RESET SIGNATURE WITHOUT KNOWN STUCK CLOSED REED SWITCH ISSUES. IT WAS LATER REPORTED THAT PATIENT HAD SURGERY. IN SURGERY, PRE-OP DIAGNOSTICS SHOWED THE GENERATOR WAS DISABLED AND THE LEAD IMPEDANCE WAS LOW. THE SURGEON INSPECTED LEAD AND REPLACED THE GENERATOR WITH NEW MODEL 1000 GENERATOR. DIAGNOSTICS WERE RAN 3 TIMES AND ALL WERE LEAD IMPEDANCE WITHIN NORMAL LIMITS. THIS MDR HOUSES THE REPORT OF REED SWITCH MALFUNCTION ON THE PATIENT'S GENERATOR. MFR REF#: 1644487-2023-00155 HOUSES THE REPORT OF UNRELATED UNINTENTIONAL RESET ON THE PATIENT'S GENERATOR.
IT WAS LATER REPORTED THAT THE SUSPECT DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.
IT WAS LATER REPORTED THAT PATIENT WAS INTERROGATED AND IT STATED THAT DEVICE WAS DISABLED. WHEN DIAGNOSTICS WAS RAN, IT CAME BACK AS DISABLED AND SAID LEAD IMPEDANCE WAS LOW AND BATTERY LIFE OK. DEVICE RESET WAS THEN DONE AND ONCE COMPLETED IT STATED THAT DEVICE WAS STILL DISABLED. A REFERRAL FOR A GENERATOR REPLACEMENT WAS PLACED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
PRODUCT ANALYSIS (PA) WAS COMPLETED FOR THE GENERATOR. THE REPORTED REED SWITCH MALFUNCTION, CLOSED REED SWITCH, GENERATOR RESET, AND DEVICE FAILURE WERE ALL CONFIRMED IN THE PA LAB. 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. DURING THE 24-HOUR OUTPUT SIGNAL MONITORING PERIOD THE MAGNET CURRENT WOULD NOT MAINTAIN AS PROGRAMMED. AFTER EACH SWIPE WITH A LIVANOVA MAGNET, THE MAGNET CURRENT DID ACTIVATE. HOWEVER, WHEN THE MAGNET WAS HELD OVER THE GENERATOR FOR 26 MINUTES AND THEN REMOVED, THE OUTPUT SIGNAL DID NOT RESUME. WHEN THE PULSE GENERATOR WAS TAPPED THE OUTPUT SIGNAL WOULD RETURN. IF THE REED SWITCH RELEASED QUICKLY (WHEN TAPPED) THE MAGNET CURRENT MAINTAINED AS PROGRAMMED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED THE BATTERY WAS NOT DEPLETED. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION WAS PERFORMED. OTHER THAN THE REED SWITCH STUCK CLOSED CONDITION DURING THE 24-HOUR OUTPUT SIGNAL MONITORING PERIOD, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1995908 | PULSE GEN MODEL 1000 | GENERATOR | LYJ | LIVANOVA USA, INC. | 1000 | 204897 | 05425025750405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Female |