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dennis100
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« Reply #120 on: May 01, 2018, 12:14:15 AM »

Model Number MODEL 250
Event Date 07/12/2013
Event Type  Malfunction   
Event Description
On (b)(6) /2013, it was reported that a handheld device was not responsive to touch. Upon hard reset, the device would not advance past the align screen prompts. The other parts of the programming system were confirmed to be working normally. The handheld device and software flashcard were returned on (b)(6) 2013 and underwent analysis. An analysis was performed on the returned flashcard and the reported allegation was not verified. During the analysis it was identified that the flashcard contained two different sets of patient databases. The cause for the anomaly is associated with the flashcard being inserted into multiple handheld devices. No functional anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. An analysis was performed on the returned handheld. During the analysis it was identified that the touchscreen display was unresponsive. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3253817
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« Reply #121 on: June 14, 2018, 12:31:01 AM »

Model Number 250
Event Date 04/05/2010
Event Type  Malfunction   
Event Description
Initial reporter indicated that their (b)(6) handheld computer containing 7. 1 programming software was freezing on the interrogation successful screen. The 7. 1 programming software flashcard was reseated and the problem resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1659944
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dennis100
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« Reply #122 on: June 15, 2018, 12:42:15 AM »

Model Number 250
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the site that they were having problems with their handheld. It would not interrogate initially and if interrogation went through, then they would have problems with programming. This issue occurred with several different patients on the same day. Company representative talked to the site and indicated that the problem appears to be a screen freezing. He informed the site to remove the flashcard and re-insert it. After doing that, the problem was resolved; however, there was no pt at the office to interrogate. Good faith attempts to obtain add'l info have been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1655345
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dennis100
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« Reply #123 on: July 31, 2018, 03:31:27 AM »

Model Number MODEL 250
Event Date 10/05/2010
Event Type  Malfunction   
Event Description
It was reported that a physician's assistant was receiving sql errors on his dell x50 handheld device. The assistant performed a rest; however the screen would not progress past the error message and he was unable to perform interrogations. The assistant stated that a company representative had visited the site and put the flashcard from his previous handheld device into the dell x50 and that is when the error messages were obtained. A new handheld was sent to the physician and he was instructed to not insert the old flashcard into the new handheld. (b)(4) attempts to obtain the dell x50 with the error messages have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1893182
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dennis100
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« Reply #124 on: October 20, 2018, 12:11:32 PM »

Model Number MODEL 250
Event Date 07/13/2012
Event Type  Malfunction   
Event Description
During review of the product analysis for the explanted generator replaced on (b)(6) 2012 due to eri=yes, it was observed that the as-received settings in the product analysis lab were indicative of a faulted diagnostic test occurring. It is unknown with the information at this time if the faulted diagnostic test occurred on the date of surgery prior to explant or sometime prior to surgery. Attempts for a copy of the physicians' flashcards to review the programming/diagnostic history has been unsuccessful to date. The pulse generator module performed according to functional specifications during product analysis. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Analysis of programming history and as-received programmed settings in the product analysis lab.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2741882
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dennis100
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« Reply #125 on: October 31, 2018, 01:12:25 AM »

Model Number MODEL 250
Event Date 09/27/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Product analysis was performed on v8. 1 software, as captured in manufacturer report number: 1644487-2012-02691, which revealed that the flashcard software identified that the cyberonics. Cdb database was corrupt and that the file corruption occurred prior to the v8. 1 upgrade. A root cause for file corruption could not be identified based on the available information. The v8. 1 software performed as expected and transferred the corrupt database during the upgrade. It was also identified that the cyberonics80 did not match the databases in the handheld giving the indication that the flashcard was used to upgrade another handheld. No further anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852991
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dennis100
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« Reply #126 on: November 08, 2018, 01:16:47 AM »

Model Number MODEL 250
Event Date 12/20/2012
Event Type  Malfunction   
Event Description
Reporter indicated that the pins located on the handheld computer were bent and that the flashcard was unable to be inserted. The physician indicated that there was nothing that could have occurred that would have caused the pins to become bent nor were there any accidental attempts to place the flashcard in the handheld backwards. The handheld was returned to device manufacturer for analysis on (b)(6) 2013; however, analysis has not yet been completed to date.
 
Event Description
Two flashcards were returned on (b)(6) 2013 and analyzed with the handheld. Visual analysis of the handheld verified that five of the flashcard slot pins were bent. The cause of the bent pins is associated with mishandling of the device. Once the pins were straightened, no anomalies associated with the handheld performance were noted. Analysis of the flashcards revealed that the 8. 1 version flashcard had 3 bent pins and as a result of the bent pins, the returned handheld would freeze when the flashcard was inserted. Once the electrical shorts were removed and the pins were repaired, not further anomalies were identified. The 8. 0 version flashcard had no anomalies associated and performed according to functional specifications.
 
Manufacturer Narrative
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2902159
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dennis100
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« Reply #127 on: November 14, 2018, 07:49:55 AM »

Model Number 250-7.0
Event Date 01/09/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the physician's programming system "needs repair". He physician's nurse stated that the programming system is "not picking up a signal at all". The physician has other programming systems that they have been able to successfully use to interrogate patients. Attempts for further information are underway but no additional information has been received to date.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the programming system is now working properly. One of the physicians at the office found a couple of things wrong with the handheld; the back latch was open and the flashcard wasn't inserted all the way. He fixed these couple of things and now the programming system works fine and the office wants to keep it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950376
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dennis100
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« Reply #128 on: November 15, 2018, 07:41:29 AM »

Model Number MODEL 250
Event Date 01/07/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 the physician called for guidance on how to install the newest 8. 1 software. Prior to install, the physician verified that the front screen of the handheld indicated 7. 1 version software. After removing the flashcard from the handheld though, it was discovered that it was actually 8. 0 version software. When the 8. 1 version software was placed in the handheld, the software would not self install. An attempt was made to uninstall the previous software; however, the physician was unable to pull up the cf card file to do so. It appears the 8. 0 software was never initially installed, which would cause the issues in installing the 8. 1 software. Attempts have been made for the product return; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2945696
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dennis100
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« Reply #129 on: December 13, 2018, 03:50:49 AM »

Model Number MODEL 250
Event Date 08/12/2013
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the incorrect lot number was incorrectly reported on the initial mdr.

Event Description
On (b)(6) 2013 it was reported that the handheld showed the message, "unrecognized card error - enter name of the device driver for this card. For information, see the card manufacturer's documentation. " the device was turned on and off and the sd card was taken out and re-inserted. The error was intermittent, but would often show up within a minute of loading the card. The site has been using this sd card for the duration of the study, since at least (b)(6) 2012. However, the nurse stated that this error has only occurred on (b)(6) 2013. A new sd card was sent to the site. It is unknown if the error has resolved with the new card. Attempts are underway for additional information; however, no additional information has been received to date.

Manufacturer Narrative
New information received corrects the date reported on initial mfr. Report. Returned to manufacturer; corrected data: this information was inadvertently left off of supplemental mfr. Report #1. Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

Event Description
Follow up with the site found that the error previously reported did not only occur with interrogation. The physician was provided a new flashcard; however, it was reported that the same error occurred with the new card. When the old flashcard was placed in the hand held again, the same error appeared and a page came up that the site could not get off of. The handheld and flashcards were returned to the manufacturer and are pending product analysis.

Event Description
Analysis of the software was completed on (b)(4) 2013. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the handheld was completed on (b)(4) 2013. No software anomalies were identified during the analysis. During the analysis it was identified that the handheld would display an ¿unrecognized card¿ message when the flashcard was inserted into the handheld. The cause for the message is associated with a bent flashcard slot pin. Once the pin was straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3340158
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dennis100
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« Reply #130 on: December 15, 2018, 01:25:38 AM »

Model Number MODEL 250
Event Date 02/07/2012
Event Type  Malfunction   
Event Description
During review of product analysis results for this explanted generator, it was noted that the device was returned at faulted settings. It is unknown when the settings were changed to faulted settings, and no programming history is available. It is also unknown which handheld device and software flashcard were involved in the event. Attempts to obtain programming history for this patient are underway, but no information has been received to date.

Manufacturer Narrative
Analysis of product analysis results.

Event Description
On (b)(6) 2012, the physician reported that he would not provide a copy of his flashcard for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2582199
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dennis100
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« Reply #131 on: December 21, 2018, 08:56:40 AM »

Model Number MODEL 250
Event Date 10/07/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld software was not installed on the new handheld and would not allow for installation. An error message was received so you want to try to format this storage card to make readable this will permanently delete any files on the card. The handheld and flashcard were received for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3451997
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dennis100
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« Reply #132 on: January 16, 2019, 01:41:07 AM »

Model Number MODEL 250
Device Problem Operating System Becomes Nonfunctional
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
It was reported that a hospital handheld was expeirencing screen freezes and a new programming computer was requested. It is unknown if any troubleshooting was performed. The handheld is expected to be returned for analysis, but has not been received to date.
 
Manufacturer Narrative

Event Description
The suspected programming computer has been returned on 01/11/2016 for the analysis. The flashcard software has been not returned to date. An analysis was performed on the returned handheld and the reported "frozen screen" was not verified. During the analysis it was identified that a known good flashcard could not be fully inserted into the returned handheld. The cause for the anomaly is associated with a bent flashcard slot pin. Once the pin was straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. That malfunction, found during the analysis, is reported in the mfr. Report # 1644487-2016-00233.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3903071
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dennis100
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« Reply #133 on: February 24, 2019, 05:30:41 AM »

Model Number MODEL 250
Device Problems Screen; Computer Software Problem; Handpiece
Event Date 04/20/2015
Event Type  Malfunction   
Event Description
The flashcard was sent to the manufacturer and the cause for the anomaly is associated with a damaged connector pin. No other anomalies were identified.
 
Event Description
An analysis was performed on the returned serial cable and no anomalies associated with the serial cable were noted. The serial cable performed according to functional specifications.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
An analysis was performed on the returned flashcard and no anomalies associated with the vns software were identified. During the analysis it was identified that the vns software would not load into the handheld. The cause for the identified anomaly is associated with a defective flashcard. No further anomalies were identified. An analysis was performed on the handheld and no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications.
 
Event Description
It was reported that the physician¿s handheld computer did not install the vns programming software. The medical professional indicated that the handheld computer displayed the operating system¿s screen despite attempting a hard reset. It was reported that the vns software flashcard was properly inserted in its compartment of the handheld computer. The software flashcard and the handheld computer have been returned to the manufacturer. Analysis is underway but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4773717
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dennis100
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« Reply #134 on: February 26, 2019, 01:35:17 AM »

Model Number 250-7.1
Event Date 11/11/2010
Event Type  Malfunction   
Event Description
It was initially reported by a company rep that the physician was receiving an error message, failure to execute - sql error. The hand held computer and the software were returned to the mfr for eval. Product analysis on the software confirmed the error message that was reported and identified that the cyberoncbu. Cdb database on the returned flashcard was corrupt. The cause for the file corruption is unk and could not be determined during the analysis. The archive databases were not corrupted. No further anomalies were identified during the analysis of the software. Product analysis for the hand held computer showed no anomalies associated with the handheld during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1949181
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« Reply #135 on: March 01, 2019, 01:12:15 AM »

Model Number MODEL 250
Device Problem Device Operates Differently Than Expected
Event Date 05/08/2015
Event Type  Malfunction   
Event Description
A report was received from an overseas distributor regarding a provider's handheld device stating that the device does not detect. A reset of the handheld device was performed at a later date, however, it was reported that the handheld device does not recognize generators. It was stated that the programming wand is functioning properly. The handheld device and associated software have not been returned to the manufacturer for product analysis.
 
Event Description
The international distributor reported that when resetting the handheld device the device shuts down, restarts again and reinstalls the software. The distributor stated, "subsequently question test is performed with the generator and successful demonstration. " the handheld device and associated software have not been returned to the manufacturer for product analysis.
 
Manufacturer Narrative

Event Description
Analysis of the flashcard software indicated that the folder containing the vns installation files was missing. No anomalies associated with the vns patient databases were identified during the flashcard analysis. The report from the international distributor indicated that the vns software would reinstall properly following device reboots indicating that the properly installations files were on the flashcard during distributor testing. The root cause of the missing installation files on the flashcard could not be identified during analysis but it is deemed to be a user-related event.
 
Event Description
Product analysis was completed on the returned handheld device and no anomalies were anomalies; the handheld device performed according to functional specifications in the product analysis lab. The associated flashcard software was received by the manufacturer and is currently undergoing product analysis. Paperwork received with the software indicated, "damage hhd" however, no damage was noted with the returned handheld device (hhd).
 
Event Description
The suspect handheld device was received by the manufacturer and is currently undergoing product analysis. Paperwork received with the suspect device indicates that the reason for return was, "handheld damage" and "explant mode of silence return imported from usa. " the associated flashcard software was not returned with the handheld device. Attempts for additional relevant information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4943563
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dennis100
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« Reply #136 on: March 05, 2019, 05:23:44 AM »

Model Number MODEL 250
Device Problems Keypad; Device Inoperable
Event Date 07/29/2015
Event Type  Malfunction   
Event Description
The suspect device was received by the manufacturer. Analysis of the device is underway, but it has not been completed to date.
 
Event Description
An analysis was performed on the returned handheld and no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. An analysis was performed on the returned flashcard. During the analysis it was identified that the vns files had been deleted from the flashcard and were stored in the. Trashes folder. Evidence suggests the files had to have existed on the flashcard at one time. Additionally, it was identified that the flashcard contained 2 different sets of patient data. The cause for the multiple database anomaly is associated with the flashcard being using in multiple handheld devices. No other anomalies were identified.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Manufacturer Narrative

Event Description
It was reported that the touchscreen of the handheld computer would not respond to taps. The handheld computer was reset a number of times. It was verified that the lock button was not activated. The handheld computer's battery was removed and put back in. The reported event did not resolve. The suspect handheld computer has not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5017242
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« Reply #137 on: March 23, 2019, 12:41:15 AM »

Model Number 103
Device Problems Device Operates Differently Than Expected; Programming Issue
Event Date 11/25/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was seen by the physician and the vns showed ifi=yes. The physician stated that he has the patient at a 49% duty cycle but doesn't think the battery should be dying so soon. A battery life calculation (blc) was performed which showed 4. 1 years remaining until neos=yes. However, the most recent line of programming history was from (b)(6) 2013 which showed the device programmed to output=1ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=1. 1min which is not a 49% duty cycle and therefore the patient's settings have since been adjusted and the blc may not be accurate. Additional programming history was requested from the physician but has not been received to date.
 
Event Description
A copy of the physician's flashcard was received but it could not be read. Good faith attempts were made for another copy of the physician's flashcard but a copy has not been received to date. Clinic notes dated 12/14/2015 were received for review which indicated that the recent testing of the vns showed ifi=yes.
 
Event Description
On (b)(6) 2016 it was reported that the patient underwent prophylactic generator replacement. The explanted generator could not be returned for product analysis as the device was in the therapeutic consultant's bag that was stolen.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5306719
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« Reply #138 on: March 26, 2019, 01:20:13 AM »

Model Number MODEL 250
Device Problem Device Displays Incorrect Message
Event Date 12/15/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns physician handheld device displayed an "unrecognized card" error message. The flashcard was re-inserted and a hard reset was performed. After the "clear all data in memory" prompt was completed, the error message appeared again. The handheld device has not been returned to date.
 
Event Description
The handheld device and software flashcard were returned to the manufacturer for analysis which was completed on (b)(6) 2016 and identified that the vns software would not load when the returned flashcard was inserted. The cause for the anomaly was associated with a bent pin found in both the handheld flashcard slot and the software flashcard socket. Once the pins were straightened, no further anomalies the handheld and software flashcard were noted. Based on the information available, the root cause of the bent pin is most likely due to the user inserting the flashcard incorrectly. The manufacturer report capturing the software flashcard as the suspect device was reported in mfr. Report # 1644487-2016-00282.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5354854
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