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Author Topic: Unintentional Settings  (Read 218593 times)
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dennis100
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« Reply #1920 on: August 09, 2019, 11:27:08 PM »

Model Number 1000
Device Problem Energy Output Problem
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's vns generator was not programmed on despite the physician believing that she had programmed it on at one point. It was stated that the physician was previously able to interrogate the generator, but unable to program it. The patient was implanted in a separate territory in the state and, per the current company representative, the patient did not attend the follow up appointment and moved to the current location. Tablet data was received from the date of implant and no anomalies or indications of a reboot were noted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8809139
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dennis100
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« Reply #1921 on: August 09, 2019, 11:28:21 PM »

Model Number 1000
Device Problem Output Problem
Event Date 04/22/2019
Event Type  Malfunction   
Event Description
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764817
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dennis100
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« Reply #1922 on: August 09, 2019, 11:28:58 PM »

Model Number 106
Device Problem Energy Output Problem
Event Date 06/24/2019
Event Type  Malfunction   
Event Description
Nurse requested vns interrogation after a patient underwent defibrillation to ensure functionality of the device. The device was interrogated and the patient's settings were noted to have been changed. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8816883
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dennis100
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« Reply #1923 on: August 09, 2019, 11:29:35 PM »

Model Number 106
Device Problem Energy Output Problem
Event Date 02/27/2019
Event Type  Malfunction   
Event Description
Patient presented in the neurologist's office with the autostim output current unexpectedly programmed off. The normal and magnet mode stimulation remained unchanged and autostim output current was confirmed to not be >= magnet output current. Adjusting the heart rate threshold allowed the physician to program autostim to the desired output current. The lead impedance and battery status were ok. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444824
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dennis100
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« Reply #1924 on: August 09, 2019, 11:30:14 PM »

Model Number 3000
Device Problem Computer Software Problem
Event Date 01/19/2019
Event Type  Injury   
Event Description
It was reported that upon interrogation it appeared that the patient's m102 had been reprogrammed to 30 to incorrect settings. The physician wanted to know why this event occurred and if it could have contributed to the patient's increased seizures. Review of the data found that an interrupted communication had led to faulted diagnostics on the patient's generator at the last appointment. M102 generators change settings from programmed settings to diagnostics settings back to programmed settings to run system diagnostics; therefore, when the diagnostics were interrupted, the settings were left at the diagnostics settings. The physician did not run a final interrogation as recommended per labeling so this settings change was not found and corrected until the next appointment. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764707
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