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Author Topic: Handheld Computer/Programming Wand  (Read 278689 times)
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dennis100
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« Reply #1830 on: January 28, 2019, 05:20:26 AM »

Model Number MODEL 250
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
The programming tablet was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the tablet was completed on 12/03/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the tablet could not charge the main battery, and as a result was also not able to be powered using the main battery. The cause for the identified anomaly is associated with a loose battery cable to the motherboard. Once the cable was reseated, no further anomalies were identified during the analysis. Visual analysis also identified damage to the back cover of the tablet. The cause of the damage could not be identified during the analysis.
 
Event Description
A company representative's programming tablet has been shutting off and will only stay operational if the device is plugged directly into the electrical outlet. The battery status indicator shows 100% charged and the battery status button illuminates red lights when charging as expected. When the tablet is disconnected the tablet powers down. The company representative was provided a new programming tablet. The non-functional tablet is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4116009
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dennis100
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« Reply #1831 on: January 28, 2019, 05:21:21 AM »

Model Number MODEL 250
Event Date 08/26/2014
Event Type  Malfunction   
Event Description
It was reported that there was physical damage to the physician¿s programming tablet that occurred on (b)(6) 2014. It was reported that the usb cable for the programming wand would not connect to the tablet usb port due to the port being bent. It was reported that no patient's were affected because another programming system was available. It was reported that the tablet was used the day prior without any difficulty and placed back in locked storage after use. It is unknown if any mishandling occurred. A new programming tablet was provided to the physician. The tablet was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the programming tablet was completed on (b)(6) 2014. During the analysis, it was identified that the usb port was damaged. As a result, the tablet was unable to establish communication and generating port error messages. No further anomalies were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the programming tablet confirmed all quality tests were passed prior to distribution.
 
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=4115931
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dennis100
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« Reply #1832 on: January 28, 2019, 05:22:40 AM »

Model Number MODEL 250
Event Date 08/27/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of the tablet was completed on 10/02/2014. The cause for the complaint is associated with a defective motherboard. Once the board was replaced, no further anomalies associated with the tablet were identified during the analysis.
 
Event Description
It was reported that the physician's new programming tablet would not power on when pressing the power button. It was reported that the power button was illuminated green when pressed. It was reported that within a few seconds of pressing the button the green light would disappear. This was attempted multiple times with no result. The tablet was left plugged into the electrical outlet for a few minutes and when it was attempted to power on again it did not power on. A new programming tablet was provided to the physician. The non-functioning tablet was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115781
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dennis100
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« Reply #1833 on: January 28, 2019, 05:23:25 AM »

Model Number MODEL 250
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
It was reported that a programming handheld was broken and needed to be replaced. A replacement was sent to the company representative. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115491
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dennis100
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« Reply #1834 on: January 28, 2019, 05:23:59 AM »

Model Number MODEL 250
Event Date 08/26/2014
Event Type  Malfunction   
Event Description
It was reported that there were problems with the handheld device. The problems were not specified and the handheld device has not been returned to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4111776
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dennis100
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« Reply #1835 on: January 29, 2019, 06:40:54 AM »

Model Number MODEL 250
Event Date 08/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the vns unit in the clinic is not functioning. The notes indicate that the physician used another programming system so no patient's were affected by this. No additional relevant information has been received to date.
 
Event Description
Additional information was received stating that the physician's vns programming unit has been fixed since initial report and he cannot remember details of the issue. The physician reaffirmed that no patients were affected by this as a different programmer was available for use.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096696
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dennis100
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« Reply #1836 on: January 29, 2019, 06:41:37 AM »

Model Number MODEL 250
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the handheld device had a frozen screen and was unresponsive. A hard reset was performed and the handheld battery was reseated; however, the handheld screen froze on startup. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was identified that the contacts button was unresponsive on the handheld device. As a result, a hard reset could not be completed. The cause for the anomaly is associated with damaged leads on the contacts button ribbon cable connector on the pcb. Once the leads were soldered on to the pcb, 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4100952
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dennis100
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« Reply #1837 on: January 30, 2019, 08:35:30 AM »

Model Number MODEL 250
Event Date 08/11/2014
Event Type  Malfunction   
Event Description
It was reported that the handheld device was not working properly. The handheld was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
The handheld was returned without a battery cover. As a result, the handheld would not power on. Once a known battery cover was installed, the handheld performed according to functional specifications.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was identified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Once a known battery cover was installed, the handheld performed according to functional specifications. 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=4077150
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dennis100
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« Reply #1838 on: January 30, 2019, 08:36:08 AM »

Model Number MODEL 250
Event Date 08/11/2014
Event Type  Malfunction   
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was identified that the handheld was received with the lock button in the locked position. Since the lock button was locked, the handheld buttons and touchscreen were unresponsive. Once the lock button was moved to the unlocked position no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. 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
It was reported that the handheld device was not working properly. The handheld was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Name and address, title, first name, last name, address, zip/postal, phone #; corrected data: the previously submitted mdr provided the wrong initial reporter. Occupation; corrected data: the previously submitted mdr provided the wrong initial reporter. Initial reporter also sent report to fda; corrected data: the previously submitted mdr provided the wrong initial reporter. It is unknown if the reporter also reported the event to fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4077155
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dennis100
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« Reply #1839 on: January 31, 2019, 01:22:17 AM »

Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
Analysis of the handheld was completed on 11/07/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the handheld would not power on. The cause for the anomaly is associated with fluid damage on the main pcb. Once the pcb was replaced, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Analysis of the flashcard was completed on 11/07/2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the physician's handheld will not charge. The physician left the handheld plugged into the electrical outlet for four straight days and it still would not charge. The battery was removed and reinserted, but this did not resolve the issue. The physician was provided a new programming computer. The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210382
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dennis100
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« Reply #1840 on: February 02, 2019, 07:54:36 AM »

Model Number MODEL 250
Event Date 09/11/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld would not load the vns software. Hard resets were performed and the battery was removed and replaced. The flashcard was removed and the pins were inspected and appeared to be fine. The flashcard was reinserted and the software would still not load. It was reported that the handheld was last used approximately two weeks prior. Another programming computer was available so no patient's were affected. A new programming computer was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.
 
Event Description
Analysis of the flashcard was completed on 02/06/2015. The cause for the allegation is associated with a missing 2577 folder that contained the vns v8. 1 installation files. A cause for the missing folder could not be identified during the analysis. No further anomalies were identified. Analysis of the handheld was completed on 02/06/2015. 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.
 
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=4163793
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dennis100
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« Reply #1841 on: February 02, 2019, 07:56:01 AM »

Model Number MODEL 250
Event Date 09/18/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld was not holding a charge and would shut down when unplugged from the electrical outlet. A new programming tablet was provided to the physician. The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the handheld was completed on 11/17/2014. During the analysis the main battery was able to hold a change and power the handheld for over an hour. 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. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). No further anomalies were identified. Analysis of the flashcard was completed on 11/17/2014. 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=4170973
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dennis100
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« Reply #1842 on: February 02, 2019, 07:56:44 AM »

Model Number MODEL 250
Event Date 09/23/2014
Event Type  Malfunction   
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was identified that the handheld was unable to establish communication with a known good wand and generator. The cause for the anomaly is associated with a broken wire connection in the serial cable. Once the wire was soldered onto the serial cable pcb, no further anomalies were identified. The handheld did not shut-down or power-off by itself 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.
 
Event Description
It was reported that the physician's handheld was not working properly. It was reported that the handheld was powering down without being prompted. Troubleshooting was performed, but did not resolve the issue. A new programming tablet was provided to the physician. The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4178457
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dennis100
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« Reply #1843 on: February 03, 2019, 03:12:50 PM »

Model Number MODEL 250
Event Date 06/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of a returned handheld was completed on 09/18/2014. 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. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on. No further anomalies were identified. Analysis of the flashcard was completed on 09/18/2014. 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=4171215
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dennis100
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« Reply #1844 on: February 03, 2019, 03:14:03 PM »

Model Number MODEL 250
Event Date 10/29/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was failing to interrogate a patient's generator. A different programming system was used which successfully interrogated the patient's generator. It was reported that the handheld that was unable to interrogate the generator was freezing at the interrogation in progress screen. No troubleshooting was able to be performed at that time. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
On 01/08/2015 the handheld and flashcard were received for product analysis. On 01/20/2015 product analysis was completed on a returned handheld. During the analysis it was identified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Once a known battery cover was installed, the handheld performed according to functional specifications. This event was reported on mfr. Report # 1644487-2015-03668. Product analysis was also completed on the flashcard. No anomalies associated with flashcard software 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=4281145
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dennis100
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« Reply #1845 on: February 04, 2019, 01:16:21 AM »

Model Number 103
Event Date 10/20/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device could not be interrogated. Attempts for additional relevant information will be made.
 
Event Description
It was reported that the failure to interrogate the patient¿s generator was due to the physician¿s wand battery being dead. The issue has been resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274221
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dennis100
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« Reply #1846 on: February 04, 2019, 01:17:12 AM »

Model Number MODEL 250
Event Date 10/22/2014
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The suspect handheld was returned for analysis. An analysis was performed on the returned handheld and the reported allegation was verified. 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. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). Additionally during the analysis, it was identified that the handheld was received with the lock button in the locked position. With the lock button in the locked position, the handheld buttons and touchscreen are unresponsive. No anomalies associated with flashcard software were identified during the flashcard analysis.
 
Event Description
It was reported that the physician's handheld has been working intermittently. It was reported that the serial cable port has become loose. It was reported that the physician has not had a situation where she was unable to interrogate a patient's device; however, it has taken several attempt to successfully interrogate several patient's generators. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4255875
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dennis100
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« Reply #1847 on: February 04, 2019, 01:18:03 AM »

Model Number MODEL 250
Event Date 10/31/2014
Event Type  Malfunction   
Event Description
It was reported that the physician¿s handheld device was not performing consistently and was unreliable. The handheld constantly required hard resets to temporarily return functionality. The suspect handheld device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
The handheld device and software flashcard were returned to the manufacturer for analysis. It was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. Once connection was re-soldered, full product functionality was restored. No anomalies associated with flashcard software 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=4280286
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dennis100
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« Reply #1848 on: February 04, 2019, 01:18:49 AM »

Model Number MODEL 250
Event Date 10/27/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's programming system was giving a "retry" message when trying to interrogate patient's devices. The wand battery was changed and the issue did not resolve. The wand was changed and interrogation was possible. It was later reported that the wand was working fine and that the issue was narrowed down to the usb connector. A new usb connector was used and there were no issues interrogating the generator. The usb was found to be kinked. The usb cable was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Analysis of the returned usb adaptor was completed. The cause for the reported allegation is associated with two disconnected wire connections in the returned serial cable. Once the wires were soldered onto the serial cable pcb, no further anomalies were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277704
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dennis100
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« Reply #1849 on: February 04, 2019, 01:19:55 AM »

Model Number 201
Event Date 10/31/2014
Event Type  Malfunction   
Event Description
It was known that the failure to interrogate was associated with a depleted 9v battery in the programming wand. Although it was not confirmed that the generator was successfully interrogated, it was known that the wand battery was depleted when the patient's device was checked. It is not expected that the programming system could communicate with a dead 9v wand battery.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the physician's programming system was unable to interrogate the patient's generator. It was reported that the wand battery was depleted, but there was no backup battery available. The patient left the office without being interrogated. Further follow-up revealed that the issues with the programming system resolved with wand battery replacement. The patient has not been seen again to see if the device is able to be interrogated. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281667
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« Reply #1850 on: February 04, 2019, 01:20:44 AM »

Model Number MODEL 250
Event Date 08/22/2014
Event Type  Malfunction   
Event Description
Additional information received revealed that the programming system is functioning properly with the new programming wand.
 
Manufacturer Narrative

Event Description
It was reported that the physician's wand was not working properly. A known working wand was used with the physician's programming computer and worked. It was reported that the wand data received light would not illuminate. The physician's office was provided a new wand and the wand was returned for analysis. Analysis of the wand was completed on 09/09/2014. Analysis confirmed the integrity of the serial data cable continuity was not compromised by the dislodged strain-relief grommet. Internal visual inspection found the j1/p1 connections were intact. It is not known why the strain relief grommet became dislodged from its intended location. Although there was a visual anomaly with the strain relief grommet, the programming wand performed according to functional specifications. It is unknown if the physician's computer serial cable was used when the troubleshooting was performed and whether or not the system is working with the new wand. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4153134
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« Reply #1851 on: February 05, 2019, 02:28:06 AM »

Model Number MODEL 250
Event Date 12/10/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The handheld and related software were received by the manufacturer. An analysis was performed on the returned handheld, and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. No anomalies were found with the software/flashcard.
 
Event Description
It was reported that the physician¿s programming handheld would not stay on when unplugged from the power source. The physician¿s office reported leaving the handheld plugged into the power source for weeks, but it dies when removed from the charger. Product return is expected, but the suspect device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4365021
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« Reply #1852 on: February 05, 2019, 02:28:45 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
Analysis of the handheld was completed on 01/05/2015. 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. Analysis of the flashcard was completed on 01/05/2015. An analysis of the handheld and flashcard software identified that the cyberonicsbu. Cdb database and 6 archive databases were corrupt. Further analysis identified that all the corrupt databases were 344kb in size, giving the indication that the archive databases are copies of the original corrupt cyberonics database. A root cause for file corruption could not be identified based on the available information. No further anomalies were identified.
 
Event Description
It was reported that the while attempting interrogations, the handheld device showed "vns therapy error. Error executing sql statement. " a hard reset was performed and the software flashcard was reseated; however, the issue did not resolve. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4367119
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« Reply #1853 on: February 06, 2019, 01:21:54 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that during a prophylactic generator replacement surgery, the handheld date and time were unable to be programmed and the patient's initials were unable to be set. A different programming system was obtained and successfully programmed the patient's generator. The physician was provided a new programming tablet. The handheld and flashcard are expected to be returned for analysis, but has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4338713
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dennis100
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« Reply #1854 on: February 06, 2019, 01:22:38 AM »

Model Number MODEL 250
Event Date 11/21/2014
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 handheld device was not functioning. The battery latch would not close and therefore the device could not be used. The wand was confirmed to not be causing or contributing to the issues. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and flashcard were completed where no issues were found with the flashcard or associated software. During analysis of the handheld it was observed that the battery latch was functioning properly however the handheld device would still not power on. The cause for the inability to power on was due to a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld device from powering on (this condition can also cause the handheld device to power off intermittently). Additionally it was identified that the main battery was unable to fully charge and power the handheld device for over 30 minutes. The cause for the anomaly is associated with a defective main battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347788
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dennis100
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« Reply #1855 on: February 06, 2019, 01:23:19 AM »

Model Number MODEL 250
Event Date 11/13/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the tablet device would not power off, but instead would go into stand-by mode. Troubleshooting determined that the tablet operating system settings were programmed to put the tablet into stand-by mode whenever the power button was pressed. The settings were adjusted and the issue resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325453
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dennis100
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« Reply #1856 on: February 07, 2019, 01:02:59 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
Additional information received indicated that the original suspect serial adapter cable was discarded and that the returned serial adapter cable is a different cable. During the analysis of the handheld programmer it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged solder connections between the handheld sync connector and the main pcb. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with the returned serial cable were identified during the analysis. No anomalies were noted with the software flash card. The software performed accordingly to functional specifications.
 
Manufacturer Narrative
Report source, corrected data: the initial report inadvertently indicated a health professional was also a report source. The only report source was the company representative.
 
Event Description
It was reported that the company representative's handheld was not holding a charge after charging. Troubleshooting was performed which identified that the handheld and charging cable had an incomplete connection and that when the connection was reconnected the handheld charged and held the charge appropriately. It was reported that the handheld and cable are touchy at times but the handheld is always able to be connected and charge properly. The company representative was provided a new cable. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The handheld computer programmer, software and serial adapter cable were returned to the manufacturer for product analysis on 6/11/2015. The ac power adapter was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4432294
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dennis100
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« Reply #1857 on: February 07, 2019, 01:04:13 AM »

Model Number MODEL 250
Event Date 01/05/2015
Event Type  Malfunction   
Event Description
Product analysis was completed on the flashcard on 02/12/2015. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Product analysis was completed on the handheld on 02/12/2015. Non-responsiveness from the handheld was found to be due to a damaged connector receptacle where the serial data cable normally attaches; receptacle became partially separated from the main pcb with some broken connector pins; most likely associated with wear or excessive cable manipulation. During the analysis on the handheld it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with bad solder connections between the sync connector and the main pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached sync connector. No other anomalies were identified.
 
Manufacturer Narrative
 
Event Description
It was reported that the serial cable connection to the handheld was loose. It was verified that the issue was with the handheld as the serial cable functioned fine with another handheld. Another serial cable was tried with the handheld and it was also found to be loose in the handheld. The handheld and flashcard were returned for product analysis on 01/27/2015. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460625
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« Reply #1858 on: February 07, 2019, 01:05:27 AM »

Model Number MODEL 250
Event Date 11/10/2014
Event Type  Malfunction   
Manufacturer Narrative
 
Manufacturer Narrative
Lot #, other, corrected data: previously submitted omitted these fields regarding the likely software information.
 
Event Description
It was reported that the physician's handheld was not functioning properly. It was reported that the screen fades in and out and the physician would like a new programming tablet. The physician reported that she would like to keep the handheld because it still works occasionally. The physician was provided a new programming tablet. The handheld is not expected to be returned; therefore, no product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318692
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« Reply #1859 on: February 07, 2019, 01:06:11 AM »

Model Number 250
Event Date 11/20/2014
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2014 that during the patient¿s generator replacement, prior to opening the new generator they attempted to interrogate it and was receiving a ¿failure to open port¿ message. The message displayed instantly when she selected the ¿interrogate¿¿ option on the first screen. It didn¿t advance to the screen with the options to ¿start interrogation¿ or ¿cancel¿. The wand was unplugged and re-plugged and still received the same message. The tablet was turned off and back on and still received the same message. It was noted that the programming system was finally able to interrogate the patient and the surgery was completed with no further issues. It was noted that the physician is going to keep the tablet and will send it back for product analysis if he experiences the same issues again.
 
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the udi on the initial report.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318602
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