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Author Topic: Handheld Computer/Programming Wand  (Read 125974 times)
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dennis100
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« Reply #1620 on: August 05, 2018, 02:03:23 AM »

Event Date 12/01/2010
Event Type  Malfunction   
Event Description
It was reported that a physician was not able to perform magnet mode diagnostics on a pt's device. The physician did not provide the pt name at the time of the initial report. Good faith attempts to obtain additional information from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1944039
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dennis100
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« Reply #1621 on: August 06, 2018, 02:16:20 AM »

Model Number 250
Event Date 12/29/2010
Event Type  Malfunction   
Event Description
It was initially reported in a neurologist's clinic notes on a vns pt that on (b)(6) 2010, the pt's "magnet recordings were odd today - it showed she had used it several times on (b)(6) and she states she only used it once". Further follow-up from the neurologist's office indicated that multiple activation times were listed per line in the magnet history display. Also, the office had referred the pt for battery replacement due to this error in conjunction with the pt's other clinical symptoms, although the clinical symptoms and the magnet display error had been explained to the office as mutually exclusive. Attempts to obtain programming history have been made, and the return of the information is expected by the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1975211
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dennis100
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« Reply #1622 on: August 06, 2018, 02:16:56 AM »

Model Number MODEL 250
Event Date 11/22/2010
Event Type  Malfunction   
Event Description
It was reported that the manufacturer representative's programming system was not functioning properly. The representative had just recently received a new programming wand, however, the reporter indicated that the wand battery was depleting very quickly and she was having to replace the 9v battery often. The programming system was returned to manufacturer for analysis. Analysis of the programming wand revealed no anomalies and performed according to specifications. During analysis of the handheld, it was identified that the sync (serial data cable) connector on the handheld was damaged. As a result of the damage, the loose sync cable created a condition that elevated the wand current to 336ma (placed wand in transmit state) thus causing the wand battery to rapidly deplete. Based on the damaged connector, it 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 printed circuit board (pcb) and attached cable receptacle.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1980013
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dennis100
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« Reply #1623 on: August 07, 2018, 12:48:56 AM »

Model Number 250
Event Date 12/09/2010
Event Type  Malfunction   
Event Description
It was initially reported that a pt went to the neurologist's office to have his device checked as he was experiencing chest pain by the generator site. The pain began after the pt had a seizure and fell on the area. The physician indicated (through clinic notes) that each time she tried to perform device diagnostics, the generator would be disabled. Therefore, she was not able to complete them as she did not want to program the generator off. The pt is being referred for generator revision surgery because the generator has been implanted for 6 years and the physician feels the generator probably needs to be replaced. Good faith attempts to obtain additional info have been successful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1961253
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dennis100
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« Reply #1624 on: August 07, 2018, 12:49:26 AM »

Model Number 250
Event Date 12/20/2010
Event Type  Malfunction   
Event Description
A vns treating physician reported to their field rep in (b)(4) that they had difficulty interrogating with their programming system. A new serial cable was sent to the site and ruled out as the cause of the event. The green light on the programming wand is illuminated for over 25secs indicating that it has power. At this time, good faith attempts are underway to determine the cause of the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1973523
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dennis100
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« Reply #1625 on: August 07, 2018, 12:50:04 AM »

Model Number MODEL 250
Event Date 11/30/2010
Event Type  Malfunction   
Event Description
It was reported that a vns patient had their generator replaced for eos. After surgery, a warning was displayed on the site's handheld that reported there could be problems with lead impedance or battery voltage. However, the battery had just been replaced and the lead impedance was stating ok. Other system diagnostic checks were also performed and found to be normal. The error message is due to an interruption in communication during the programming sequence. Breaks in communication between the handheld device and generator can be caused by either patient movement or rf interference. It is possible for communication disruption to prevent the generator from receiving the final command in the programming sequence without displaying an error on the handheld. This is due to a design flaw in the software. The programmed settings will be delivered correctly once the off time of the stimulation cycle expires. The generator is performing according to specifications. The cause of the error message is due to a design flaw in the vns software.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1973660
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dennis100
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« Reply #1626 on: August 07, 2018, 12:50:36 AM »

Model Number 250
Event Date 01/26/2011
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2011, that a magnet display error occurred when a doctor was visiting with a pt on (b)(6) 2011. The doctor claimed that "the date of the activations remained the same, but each time stamp would appear under the same date", that is a different index. Each index would contain the same date and time stamps, but one less time stamp than the previous index. F/u with the physician was made and the error was said to look like a pyramid shape - every entry line had one less time stamp than the previous entry. It was explained that this error was triggered by a roll-over in the counter of the patient's generator after it reaches 65536 hours, which causes the vns software to incorrectly display the magnet swipes; however a company rep stated that the patient's generator had not yet rolled over as the patient's counter was at 60698 hours on (b)(6) 2011. Good faith attempts to date for more info on the error have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2022965
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dennis100
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« Reply #1627 on: August 11, 2018, 12:09:32 AM »

Model Number 103
Device Problem Communication or Transmission Problem
Event Date 04/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a failure to program occurred when attempting to interrogate the patient's device. An error message stating "this software is not compatible with this model of generator" was observed. It was noted x-rays were performed to see if there was a possible lead discontinuity, but the physician could not identify any defects. Follow-up provided that the issue occurs ¿9/10 times¿, indicating it is successful sometimes, but fails in most of the attempts. It was confirmed that the device did interrogate successfully initially. It was reported that rooms were changed, to rule out electromagnetic interference, but had the same results. It was reported the output current was not high. The battery status was listed as full. The device was tested with 3 different tablets, handhelds, and wands, which were all reported to have new batteries. It was reported that all the cable connections between the wand and the programming computer were secure. It was reported that the patient was not exposed to radiofrequency after the implant. X-rays were performed and showed no discontinuity. The programming systems were reported to be used daily and have had no problems checking other patient¿s devices. The generator is easily palpated due to the patient being thin. The vns magnet was not near the generator during the attempt to interrogate. The wands were rotated 45 degrees left and right, and also kept parallel to the generator location and the result was the same with no communication. Replacement surgery has been scheduled, but no known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7683488
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dennis100
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« Reply #1628 on: Today at 02:12:22 AM »

Model Number 250
Event Date 03/07/2011
Event Type  Malfunction   
Event Description
It was reported by our local distributor that while performing a 8. 0 programming software upgrade on a dell x50 handheld computer the upgrade did not complete. No issue was noted with the handheld prior to the upgrade. Manufacturer is pending the product being returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061873
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dennis100
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« Reply #1629 on: Today at 02:12:53 AM »

Model Number 250
Event Date 03/20/2011
Event Type  Malfunction   
Event Description
It was reported to our local partner in (b)(4) from a vns treating physician that after their 8. 0 programming software upgrade on their handheld computer, it displayed a sql error. The product has been returned to the manufacturer and is in analysis pending completion. No patient adverse event was involved with this issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2074544
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dennis100
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« Reply #1630 on: Today at 02:13:27 AM »

Model Number 250
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported that during an attempt to upgrade a physician's dell x50 handheld device, a company rep noted that the handheld will not stay on. The rep observed that the power light will turn off when the handheld is moved. If the serial adapter cable and power cord are moved around, the light will come on but will not stay illuminated. The physician's office confirmed that this issue has been occurring for several months and they were using a different handheld on their vns patients. When the company rep used his own power cord and serial adapter cable, he was able to use the handheld without any issues. The site has been sent replacement cables/cords and good faith attempts to have the power cord and serial adapter cable returned to the mfr for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2062201
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