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dennis100
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« Reply #30 on: January 06, 2017, 06:09:32 AM »

Model Number 106
Event Date 09/01/2016
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2016 were received in regards to the patient's generator replacement referral. It was noted the battery life was only at 20-25%, which is unexpectedly low since the generator was only implanted a little over a year prior. Additionally, the physician noted the patient was having breakthrough seizures, which were attributed to the low generator battery. It was noted the autostimulation had been programmed off. The diagnostic results were all ok and the impedance value was 2508 ohms, which is within normal limits. The battery status indicator was still showing and ifi = no (intensified follow-up indicator) condition. It was noted the patient was seizures free until the breakthrough seizures that happened twice in (b)(6) 2016. The programming history database was reviewed on 12/05/2016. The database contained programming history from date of implant, (b)(6) 2016 through (b)(6) 2016. No anomalies were noted. The patient was programmed to 1. 75/20/244/14/30 on (b)(6) 2015. The last diagnostics were performed on (b)(6) 2016, which showed ok/ok(1. 75ma)/ok(2308 ohms)/ok for system diagnostics. The information in the programming history database was decoded and reviewed. No anomalies were noted and it was confirmed that the device was not yet at the ifi condition as the device showed 2. 853v, which is above the ifi threshold. Additionally, the decoded information did show the patient had 16 completed magnet swipes between the (b)(6) 2016 visit and the (b)(6) 2016 visit, when prior to that there were zero. This indicates that between that time period, the patient may have been experiencing more symptoms related to a seizure and used the magnet for the on demand stimulation.

Manufacturer Narrative
(b)(4).

Event Description
It was identified through an internal investigation that the observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths. This finding is indicative that the generator will reach true end of service earlier than expected. A secondary cause for premature 25% battery life indicators in a small subset of associated generators may be high beginning of life (bol) battery impedance. Generators only affected by this secondary root cause would be expected to rebound back to normal battery life levels without substantial programming changes. A review of manufacturing records indicated that the generator underwent the trim test on (b)(6) 2015. Therefore the device was laser routed. The patient underwent generator replacement surgery. The explanted m106 is expected to be returned, but has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150677
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dennis100
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« Reply #31 on: January 06, 2017, 06:10:18 AM »

Model Number 106
Event Date 11/18/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's device was already at 25% battery status. The device was at 100% battery status in (b)(6) 2016. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6172271
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dennis100
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« Reply #32 on: January 06, 2017, 06:10:59 AM »

Model Number 106
Event Date 10/05/2016
Event Type Malfunction
Event Description
It was reported the patient's battery was low; however, the patient only had surgery about 1 year prior. It was noted the patient was not having any increase in seizures. The patient's generator had been implanted on (b)(6) 2015. A review of the device history record was performed on 12/08/2016 and identified that the generator passed all functional and electrical tests prior to release for distribution.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6154117
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dennis100
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« Reply #33 on: January 06, 2017, 06:11:53 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 12/01/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient reported that her physician communicated with her device, and it was already at 20% battery life only about 5 months after being implanted. The physician reduced the device settings, and he communicated to the patient that he was not concerned. The device history record of the device was reviewed, and the device performed according to specification prior to release. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6204272
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dennis100
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« Reply #34 on: January 12, 2017, 08:35:55 AM »

Model Number MODEL 250
Event Date 10/01/2012
Event Type Malfunction
Event Description
It was reported that the handheld would not power on after being plugged into the wall charging for four hours. A company representative was present at the site to performed troubleshooting. It was confirmed that the screen lock button was not engaged, the cord was replaced, a new wand was utilized, the batteries were changed and the handheld was attempted in different areas in the room which did not correct the issue. It was reported that a hard reset resolved the problem at first, but then the handheld stop communicating after a few uses. A new handheld was provided to the physician's office. The handheld is expected to be returned to device manufacturer for analysis; however, it had not been received to date.

Manufacturer Narrative

Event Description
Additional follow up found that the handheld is transported between hospitals via the neurologist, so it could be in cars exposed to (b)(6) heat during transport. Otherwise, the handheld is kept in the clinic. No other information was provided.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(4) 2013 the physician¿s handheld and flashcard were returned for product analysis. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented the main battery cover from seating properly and registering a false open battery latch condition. Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. No other anomalies were identified during analysis. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3090557
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dennis100
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« Reply #35 on: January 12, 2017, 08:36:56 AM »

Model Number MODEL 250
Event Date 06/12/2013
Event Type Malfunction
Event Description
The hhd and software flashcard were returned on (b)(6) 2013 for analysis. An analysis was performed on the returned handheld, and the reported allegation was not verified. An analysis of the main battery verified that it was able to hold a charge. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented the main battery cover from seating properly and registering a false open battery latch condition. Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. No other anomalies were identified during analysis. An analysis was performed on the returned flashcard, and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Event Description
On (b)(4) 2013 information was received from the reporter stating that the physician¿s handheld computer was not staying on. The company rep helped to perform the troubleshooting for the physician over the phone and it was confirmed that the power light would come on (orange in color) but when a hard reset was performed while the handheld computer was plugged into the wall, the screen would go blank after the initial steps of the reset were started. The physician reported that the hard reset was performed several different times and that the screen always went blank just after the screen queried the person to tap the screen to proceed. The company rep noted that the handheld computer had been plugged in the entire time during troubleshooting and overnight. Follow-up from the physician indicated that the handheld computer is not turning on. The computer was stored in a box in an air-conditioned room. The handheld computer is to be returned for analysis. Attempts for additional information are ongoing.

Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Manufacturer Narrative
Manufacture; corrected data: this information was inadvertently reported incorrectly on initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3204978
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dennis100
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« Reply #36 on: January 13, 2017, 03:41:40 AM »

Model Number MODEL 250
Event Date 06/19/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was reported that a physician¿s handheld device was not holding a charge. The physician swapped outlets, but the hhd would only hold a charge for one interrogation after being taken off of charge before the battery died. The product was returned on (b)(6) 2013 and is pending analysis.

Manufacturer Narrative

Event Description
An analysis was performed on the returned flashcard, and no 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 and the reported failure to hold a charge allegation was verified. An analysis of the handheld identified that the returned battery was defective, and unable to hold a charge. No further anomalies were identified using a known good dell battery. The returned battery was a replacement battery and did not contain the (b)(4) logo.

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=3227387
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dennis100
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« Reply #37 on: January 13, 2017, 03:42:31 AM »

Model Number MODEL 250
Event Date 07/01/2013
Event Type Malfunction
Event Description
It was reported that the reporting that the vns physician¿s handheld device had a swollen battery that prevents the device from turning on. The physician just noticed it recently, and the programming wand was functioning appropriately. Good faith attempts are currently in progress. Added that product return is expected, but the handheld has not been received to date.

Event Description
The handheld and software were returned to the manufacturer on (b)(4) 2013. An analysis was performed on the returned handheld computer for the allegation of battery failure, main battery swelling, handheld computer functionality impaired. The handheld computer was received with an ac adapter, serial cable, v8. 0 flashcard and with the main battery depleted. Visual inspection identified no anomalies. It was identified that the main battery was swollen. The handheld computer was performed using ac power supply with no anomalies and the initial setup process was performed. The back ¿up indicator read ¿very low¿, which is expected because the back-up battery will discharge if the unit is not supported by an external power source or main battery power. The handheld computer¿s main battery was fully recharged successfully using the power supply adapter. The power button light on the handheld computer was amber and then later turned green giving the indication that the main battery was fully charged. V8. 0 software was installed and interrogation and diagnostic tests were performed with no observed anomalies. The handheld was powered-on continuously using only the main battery for more than an hour. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5ma, then interrogated to verify the new settings, then a generator diagnostic test was performed during which the generator values were changed back to output currents of 0ma, and then the battery was interrogated to verify new settings. The handheld computer was tapped onto a counter and it was identified that it would suddenly power off. When the handheld computer was powered back on, a message appeared indicating that the battery latch had been opened. An inspection of the handheld identified that the battery cover was bent due to the swollen main battery and that as a result the battery cover was unable to make good contact with the battery latch switch that was on the main board. This resulted in the handheld computer receiving an intermittent false open battery latch condition. This condition can cause the handheld to power down while in use. It also can prevent the handheld computer from turning on. The main battery had a remaining charge of 1% at the conclusion of testing. This is a known issue that was previously investigated as part of (b)(4). The analysis performed on the returned handheld computer and the reported and it was identified that the battery would become swelling, preventing the main battery cover from seating properly and registering an intermittent open battery latch condition. This condition can prevent the handheld computer from powering on and intermittently powering off. Although the main battery was swollen, it was able to hold a charge and power the handheld computer for over an hour. No other anomalies were identified during analysis. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software 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=3250563
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dennis100
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« Reply #38 on: January 13, 2017, 03:43:10 AM »

Model Number MODEL 250
Event Date 02/04/2013
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013 product analysis was completed on the flashcard and handheld. An analysis was performed on the returned flashcard and no 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 and it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition (reported on mfr. Report # 1644487-2013-00521). Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. Also during the analysis it was identified that the serial cable had an open electrical connection in the power cable. As a result of the open wire connection, the handheld would receive power from the ac adapter intermittently. Product analysis determined that the cause for the break in the serial data cable is unknown. It was initially reported that the handheld does not hold a charge anymore and must be plugged into the outlet in order to use it. The manufacturer's consultant attempted to charge the handheld using his power adapter for quite some time but the device still would not hold a charge. It was noted that no user mishandling occurred; the handheld is always kept securely in the office when not in use.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3021285
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dennis100
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« Reply #39 on: January 13, 2017, 11:01:43 AM »

Model Number MODEL 250
Event Date 02/04/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the handheld does not hold a charge anymore and must be plugged into the outlet in order to use it. The manufacturer's consultant attempted to charge the handheld using his power adapter for quite some time but the device still would not hold a charge. It was noted that no user mishandling occurred; the handheld is always kept securely in the office when not in use. The handheld and flashcard were returned to the manufacturer on (b)(6) 2013 for product analysis. Product analysis is still underway and has not yet been completed. It was noted that the reason for the return of the programming system was because of the "faulty handheld. ".

Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the flashcard and handheld. An analysis was performed on the returned flashcard and no 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 and it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. Also during the analysis it was identified that the serial cable had an open electrical connection in the power cable (reported on mfr. Report # 1644487-2013-00811). As a result of the open wire connection, the handheld would receive power from the ac adapter intermittently. Product analysis determined that the cause for the break in the serial data cable is unknown.

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=2979157
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dennis100
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« Reply #40 on: January 14, 2017, 03:07:25 AM »

Model Number MODEL 250
Event Date 12/20/2012
Event Type Malfunction
Manufacturer Narrative
Event Description
On (b)(4) 2012, it was reported to the manufacturer that a (b)(4) handheld device used by the physician is not holding charge. A replacement handheld was sent to the physician and the handheld device in question was returned to the manufacturer on (b)(4) 2013. Product analysis is currently in progress and has not been completed at this time. It is currently unknown how the handheld device is stored when not in use and if any user mishandling or user error occurred.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that product analysis was completed on the handheld and flashcard. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. No further anomalies were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2921011
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dennis100
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« Reply #41 on: January 14, 2017, 07:58:57 AM »

Model Number MODEL 250
Event Date 09/01/2012
Event Type Malfunction
Manufacturer Narrative
The initial report inadvertently reported the date of event incorrectly as it was reported the event had occurred for about a month prior to the report on (b)(6) 2012. The supplemental report #1 inadvertently did not report the serial number.

Event Description
Was reported by a physician that his programming system would intermittently freeze on various screens. Per the physician this problem has been occurring over the past month. They explained that they have tried performing hard resets, but this sometimes doesn't resolve the issue right away. A new handheld was shipped to the physician, however the handheld in question has not yet been returned to the manufacturer for analysis.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Follow-up with the physician's office revealed that the handheld was usually stored inside a drawer. The handheld was not exposed to any extreme temperatures, stored or transported with any metal objects, or accidentally dropped/ mishandled.

Manufacturer Narrative

Event Description
The handheld and flashcard were returned to the manufacturer on (b)(4) 2012 and analysis has since been completed. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the returned handheld, it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. No further anomalies were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2807947
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dennis100
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« Reply #42 on: January 14, 2017, 11:39:58 AM »

Model Number 250
Event Date 09/10/2012
Event Type Malfunction
Event Description
A vns programming physician reported that his dell x50 handheld computer would not turn on. It was plugged into the charger and it had been charging for over 5 minutes, but still would not power on, even with the handheld plugged in. The lock switch was in the "unlocked" position. The screen was completely black, not just a dim image. A hard reset was attempted, but could not be performed, and the screen still remained black. The handheld has been returned and analysis completion is pending.

Manufacturer Narrative

Event Description
An analysis was performed on the returned handheld and a cause for the reported allegation was identified. During the analysis it was verified that the handheld would not power on the cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. No further anomalies were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard 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=2775529
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dennis100
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« Reply #43 on: January 16, 2017, 03:53:28 AM »

Model Number MODEL 250
Event Date 09/13/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the programming handheld will not hold a charge and keeps going flat. It was reported that the cables were changed out with another handheld; however, this did not correct the problem. It was reported that troubleshooting was performed by using a battery from another handheld and the handheld turned on without any problems. It was reported that the site has multiple programming systems so no patient's were affected. The handheld is expected to be returned, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3407828
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dennis100
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« Reply #44 on: January 16, 2017, 03:54:31 AM »

Model Number 201
Event Date 01/01/2013
Event Type Malfunction
Event Description
The physician's office reported that it is unsure if the vns programming system is working. No specific details were provided and troubleshooting was declined. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
New information changes the suspect device.

Event Description
Follow up with the physician found that the handheld was working fine as of (b)(6 2013. The only problem was the battery in the wand needed replacement. After the battery was replaced, the physician was able to successfully interrogate and program the patient with no further issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3348103
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dennis100
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« Reply #45 on: January 16, 2017, 03:55:17 AM »

Model Number 250
Event Date 03/13/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that physician's dell handheld computer contined to freeze during initial interrogation, indicating a possible software malfunction. The handheld and software were returned for product analysis. Analysis of the returned handheld found there was loose screw near the main battery terminal allowing for rapid loss of battery power. The loss of battery power made it appear the handheld was frozen. No anomalles were found in the product analysis of the 7. 1 software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948936
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dennis100
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« Reply #46 on: January 16, 2017, 03:56:05 AM »

Model Number MODEL 250
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated a handheld computer was not holding a charge, indicating a possible battery failure. Product analysis was completed on the returned handheld computer. No anomalies were found that could have contributed to the reported battery failure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948433
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dennis100
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« Reply #47 on: January 16, 2017, 03:57:14 AM »

Model Number 250
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
Event Description
Reporter indicated that display on laptop was faulty. Laptop was returned to the manufacturer. Product analysis indicated that the laptop computer's main battery would not hold a charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950147
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dennis100
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« Reply #48 on: January 16, 2017, 03:58:07 AM »

Model Number MODEL 250
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated a dell handheld computer would not hold a charge despite the computer being charged properly, indicating a possible battery malfunction. The handheld computer and flashcard are currently in product analysis.

Manufacturer Narrative
Device failure is suspected, 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=967125
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« Reply #49 on: January 16, 2017, 03:59:02 AM »

Model Number MODEL 250
Event Date 04/05/2007
Event Type Malfunction
Event Description
Reporter indicated that the site's battery from the hp jordana handheld is no longer holding charge. The handheld computer was returned for product analysis. Analysis of the returned product is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959861
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dennis100
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« Reply #50 on: January 16, 2017, 08:23:26 AM »

Model Number MODEL 250
Event Date 05/18/2012
Event Type Malfunction
Event Description
Additional information from the area representative indicated the handheld did not have a software and it would not sustain charge. Troubleshooting was performed but proved to be unsuccessful. Mishandling of the handheld computer is suspected from the physician. Complaint from received from territory manager, (b)(6) to report that: she has been informed on (b)(6), 2012 by a distributor that physician's hhd had a problem and it doesn't work anymore. The reported handheld and software remain underway to be returned to the manufacturer. The serial cable accompanying the handheld would not be returned for analysis as the physician disposed of the material.

Event Description
It was reported by a company representative that a physician's handheld computer had a problem and it would not work any longer. Additional information from the area representative indicated the handheld did not have a software and it would not sustain charge. Troubleshooting was performed but proved to be unsuccessful. Mishandling of the handheld computer is suspected from the physician. The reported handheld and software were returned to the manufacturer and remain under analysis. The serial cable accompanying the handheld would not be returned for analysis as the physician disposed of the material.

Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently listed incorrect summary of event. Type of report, corrected data: initial report inadvertently did not list type of report. Initial report should have had indicated 30-day report.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the flashcard and handheld. No 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 and a likely cause for the reported complaint that the battery would not hold a charge was verified. During the analysis it was identified that the main battery was swollen and not making good electrical contact with the handheld. As a result, the battery was unable to be charged using the handheld. The cause for the swollen battery is unknown. No further anomalies were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2605019
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dennis100
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« Reply #51 on: January 16, 2017, 12:46:05 PM »

Model Number MODEL 250
Event Date 05/01/2012
Event Type Malfunction
Event Description
On (b)(6) 2012, a vns treating neurologist reported that her handheld would not turn on after charging overnight. The physician was able to briefly use the handheld for an interrogation, but then the handheld turned off and would not come back on. The physician plugged the handheld back into the power outlet and still would not power on. A hard reset and a soft reset were both performed, but did not resolve the issue. The red power light was coming on and the hard reset had been attempted while the handheld was plugged into the power outlet. The lock button was reported not to be engaged. The manufacturer's consultant later reported that she thinks that the problem may be that the battery latch is not staying closed even though it is locked. Attempts are underway for the return of the handheld for product analysis; however it has not been received by the manufacturer to date.

Event Description
Additional information was received on (b)(6) 2012, when the handheld and flashcard were returned for product analysis. Product analysis on the handheld and flashcard was completed on (b)(6) 2012. During analysis it was verified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented the main battery cover from seating properly and registering a false open battery latch condition due to the slight bulge. No further anomalies were identified during the analysis. The cause for the swollen battery was unknown. No anomalies associated with the battery latch were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury. Type of report; corrected data: inadvertently did not check "30-day" on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2587622
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dennis100
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« Reply #52 on: January 17, 2017, 03:01:17 AM »

Model Number MODEL 250
Event Date 04/20/2012
Event Type Malfunction
Event Description
On (b)(6) 2012, a vns treating physician reported that his handheld was not working and that the battery cover of the handheld somehow fell off and they could not find it. The manufacturer's consultant verified that the battery cover was gone however it was not known whether the physician's office had dropped the handheld before. The handheld and flashcard were returned to the manufacturer for product analysis. Product analysis on the handheld revealed that the battery door was indeed missing, the main battery was installed backwards, and the handheld was unable to charge the main battery. The cause for the missing battery door and incorrectly installed battery are most likely associated with user error. The cause for the handheld not charging the main battery is associated with broken solder connections between the battery terminal and the main pcb. Once the solder connections were restored, no further anomalies were identified. Product analysis on the flashcard revealed no anomalies associated with flashcard software or databases. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2572594
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« Reply #53 on: January 17, 2017, 03:02:07 AM »

Model Number MODEL 250
Event Date 03/22/2012
Event Type Malfunction
Manufacturer Narrative
Suspect medical device, corrected data: the incorrect serial number was inadvertently reported on the initial mdr report. The correct serial number is provided. Report type, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.

Event Description
Reporter indicated a vns programming system (handheld computer, programming wand, and flashcard) was performing intermittently. The system would not interrogate vns patients consistently, the screen would freeze on an unknown screen, and the system would require recalibration. The reporter was able to use back-up vns programming systems successfully, and no patients were affected by the suspect programming system. Attempts for return of the vns programming system for product analysis are in progress.

Event Description
The vns programming wand, computer and flashcard were returned for analysis on (b)(6) 2012. Analysis of the wand did not reveal any anomalies, and the wand performed per specifications. Analysis of the computer and flashcard is pending.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis of the computer and flashcard was completed. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. No further anomalies were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2541214
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dennis100
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« Reply #54 on: January 18, 2017, 02:30:24 AM »

Model Number MODEL 250
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure suspected but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the physician's dell x50 handheld computer had a faulty battery latch. The handheld computer would sometimes work normally, however other times it would erroneously indicate the battery latch was open resulting in the handheld computer turning itself off. The faulty handheld computer and associated software has been returned and is currently undergoing analysis. No adverse events have been reported as a result of the issue.

Event Description
Analysis of the faulty handheld computer and associated software has been completed. A swollen battery was found that prevented the battery cover from being able to be completely secured. As a result, when the handheld computer was tapped on the counter, the battery door would shift slightly causing the handheld to incorrectly read that the battery latch was open. Otherwise, the handheld computer performed to specifications and no anomalies were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511679
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« Reply #55 on: January 18, 2017, 02:31:32 AM »

Model Number MODEL 250
Event Date 03/05/2012
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by a company representative that a handheld could not perform as intended as the battery cover for the device was not closing well in turn switching the handheld to standby. The area representative indicated that troubleshooting was performed as a hard reset and reinstating the battery without success. The reported handheld was returned to the manufacturer and currently undergoing analysis.

Event Description
Analysis was completed on the returned handheld and software. Analysis of the returned handheld indicated no anomalies associated with the battery latch were identified during the analysis. However, during the analysis it was identified that the main battery was swollen. The swollen battery prevented the battery cover from seating properly in the handheld case. As a result, when the handheld was tapped on the counter, the battery door would shift slightly causing the handheld to incorrectly read that the battery latch was open. No other anomalies were identified during the analysis. Moreover, analysis of the returned flashcard indicated no anomalies associated with flashcard software or databases were identified during the flashcard analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511549
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dennis100
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« Reply #56 on: January 19, 2017, 12:29:42 AM »

Model Number 250
Event Date 01/06/2012
Event Type Malfunction
Event Description
It was initially reported that the physician was having trouble with their handheld turning on. It was reported that the handheld was charged but would not come on. It was confirmed that the lock button was not engaged. A hard reset was attempted three times but nothing happened. A company representative went to the site to troubleshoot the issue further but was unable to resolve it. Good faith attempts for product return and additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received that the handheld and flashcard were returned to the manufacturer for evaluation. During the analysis it was identified that the handheld was received without a battery cover. As a result, the handheld would not power on. Additionally it was identified that the main battery was inserted backwards. The condition can prevent handheld from operating on battery power. No further anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2431915
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« Reply #57 on: January 19, 2017, 12:30:24 AM »

Model Number MODEL 250
Event Date 12/15/2011
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the physician¿s programming system was not functioning properly. The programming system was returned and analysis has been completed. An analysis was performed on the handheld. No functional anomalies associated with the handheld performance were identified during the analysis. A visual analysis of the handheld identified that the main battery was swollen; however this had no functional impact on the device performance. The handheld performed according to functional specifications. An analysis was performed on the flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414142
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dennis100
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« Reply #58 on: January 20, 2017, 07:26:09 AM »

Model Number 250
Event Date 07/26/2011
Event Type Malfunction
Event Description
It was reported by the physician that the hand-held device's (hhd) battery latch is open and would not close because the battery was "warped". Consequently, the hhd was not able to be used. The hhd was commonly stored on the top office counter and was not involved in any recent mishandlings. The product's return is expected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2258012
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dennis100
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« Reply #59 on: January 22, 2017, 03:01:26 AM »

Model
« Last Edit: February 11, 2018, 11:16:01 AM by dennis100 » Logged
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