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Model Number 1000 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/22/2019 |
Event Type
malfunction
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Event Description
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It was reported by the tc that an unusual error code was seen with an m1000 that was implanted a year prior.The error code indicated upon interrogation that the generator was deactivated due to error code 6.The error code was obtained upon interrogation with 2 different programmers.The device was turned back on but the autostimulation was not.The data was reviewed and it was determined that the generator had reset approximately a month and a half prior to detection during easter holiday.No obvious anomalies were identified.At the next patient appointment approximately 3 weeks later, the patient's generator was again found to be disabled due to error code 6.Per the session report, the generator had provided normal mode stimulation 15% of the time since the last visit.The generator was programmed to provide 16% normal mode stimulation.Reboot reason of 6 means that a non-maskable interrupt (nmi) occurred.It was determined that out of the possible causes of the nmi only fram (ferroelectric random access memory) bit error or oscillator fault are considered possible causes in this particular case.It should be noted that an oscillator fault may be transient as a result of emi or repeating, due to component failure.The generator's device history records were reviewed.The generator passed final functional and quality specifications prior to release.No further relevant information has been received to date.
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Event Description
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It was found that the reason for the 2nd error code 6 message was that the first error code message was never cleared since the settings were never explicitly programmed.Although a m1000 generator will turn back on upon system diagnostics/advanced interrogations, a reboot is only cleared after an explicit programming operation has completed.However, even though the error code wasn't cleared, the generator was still re-enabled and working after the first time the error code 6 was seen.The day of the reset, the patient did not go anywhere.No further relevant information has been received to date.
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Event Description
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Internal investigation identified possible causes of the reset.While no conclusive root cause was identified, a comprehensive review of device design identified several potential root causes.These include rare single bit upset corruption events within the device sram, firmware anomalies that could trigger automatic reset of the device under certain circumstances, or transient hardware faults.No further relevant information has been received to date.
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Search Alerts/Recalls
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