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dennis100
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« on: July 13, 2017, 03:07:29 AM »

Model Number 304-20
Event Date 11/01/2010
Event Type  Malfunction  
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a serious injury or death.
 
Event Description
It was initially reported by the surgeon that the pt's negative lead wire appeared to be bent when taken out from the sterile package during pt's initial implant surgery. Surgeon did not even attempt to implant the device and used another lead in stock. Lead was returned for analysis. Analysis was completed on the lead and the reported allegation was verified. The negative coil was found to be kinked. Other than the above mentioned observations, no anomalies were identified with the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937745
« Last Edit: February 26, 2019, 02:06:12 AM by dennis100 » Logged
dennis100
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« Reply #1 on: July 18, 2017, 08:48:03 AM »

Model Number 103
Event Date 03/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient was complaining of pain at the generator site. It was not tied to any cycle, and the mother stated it occurred randomly. It was noted that the patient was intellectually disabled. He had an x-ray that radiology thought looked like a kink in the lead, but the surgeon did not think so. The pain resolved when the device was turned off. The surgeon programmed the device to the lowest settings, and the pain returned. At the (b)(6) 2013 visit, the patient gave the impression that the pain occurred when he was handling other electronic devices (dvd player, handheld electronic devices) and receives a shock in his hand. This then was followed by pain at his device. The mother stated that the pain had lasted as long as 10 minutes or until she put a magnet over the generator. None of his parameters would give him 10 minutes of stimulation. The neurologist speculated if some static shock was leading to some fault in the vns programming. The neurologist increased the output current in the office, and the patient had no complaints for the 20 minutes he was there. The patient was seen again on (b)(6) 2013. The pain was better, but they pinpointed the pain occurring whenever he plugged a device into a power outlet. They no longer permitted him to do this. Otherwise he was tolerating his device settings well. The neurologist interrogated the device and noted that he has had 658 magnet activations since implanted in (b)(6) 2012, but the last activation appeared to have been on (b)(6) 2013. Notably, he has had a few episodes of pain since i last saw him on (b)(6) 2013. The output current was increased because he was still having multiple generalized convulsions weekly, which he tolerated. However, the neurologist was still concerned that the patient would have pain in the context described. The neurologist also noted that the patient tolerated the device fine as long as he was not plugging in some other device. The episodes had decreased in occurrence by avoiding plugging in objects. Additional information was received stating that the patient was seen in the (b)(6) 2015. The patient was experiencing painful stimulation at the generator and electrode sites as well as headaches. The neurologist believed that the patient¿s lead was kinked based on x-ray images. The patient underwent surgery on (b)(6) 2015 to explant his device. The explanted device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Information was received from a nurse at the neurologist's office. She indicated that the patient had pain near the vns site and had not complained of headaches. The pain started around (b)(6) 2013. The pain is related to vns and started after blood pressure cuff over chest near vns device. The pain was not associated with the duty cycle. The pain always stopped when magnet was taped over vns. The device was explanted because there is not a recurring benefit from device (initially there was) and due to pain. Explant of the lead was up to the surgeon. It is unknown if the lead was explanted. There is a plan for replacement. X-rays were received from the neurologist's office and reviewed by company representatives. One ap and one lateral view image was taken which included the lead and generator in each. The lateral image was unable to be assessed due to the image quality. The ap image was reviewed. The generator was placed normally in the left chest. The lead pin was fully inserted inside the connector block, and the filter feed-thru wires appeared fully intact. A short portion of lead was located behind the generator. The area of the electrode site could not be assessed as the angle of the image overlaid the wires such that the separate lengths of wire could not be distinguished. In the lead portions that could be visualized, there were no gross fractures or discontinuities observed. Based on the x-rays received, the cause for the reported pain and painful stimulation cannot be determined. There was nothing seen that would indicate there was any damage to the generator or lead, leading to a pain scenario. However, the presence of a micro-fracture in the lead or abraded insulation cannot be ruled out.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Event description; corrected data: the previously submitted mdr inadvertently did not include the information provided by the nurse. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4859662
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dennis100
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« Reply #2 on: July 18, 2017, 08:49:04 AM »

Model Number 300-20
Event Date 09/13/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Rptr indicated that he had rec'd high impedance during a systems diagnostics test of the vns. X-rays were sent to the mfr and reviewed. From x-rays, it appeared that the lead pins were not fully inserted. No other anomalies were noted but a lead fracture could not be ruled out. During surgery, the surgeon connected a new vns generator to the existing leads and still rec'd high impedance, ruling out the lead pins not being fully inserted as the cause of the high impedance. The lead and generator were replaced and the new vns system was confirmed as functioning properly. It was noted that the removed lead appeared to be kinked. A lead fracture is likely. The explanted products are currently being returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1881770
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dennis100
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« Reply #3 on: July 18, 2017, 08:49:44 AM »

Model Number 302-20
Event Date 08/27/2010
Event Type  Malfunction   
Event Description
It was initially reported that high lead impedance was observed during the pt's appt. The pt was programmed to 0. 25 ma and was increased to 0. 50 ma, but was unable to tolerate due to pain. The pt was referred for x-rays and disabled at that time. Diagnostics were not said to have been performed, but was instead seen as a warning message following interrogation of the device. Review of clinic notes received indicated that the pt was increased to 0. 50 ma on (b)(6) 2010 with only reported voice alteration and being uncomfortable. The pt was later decreased back to 0. 25 ma due to the adverse issues on (b)(6) 2010. The pt's duty cycle was increased on (b)(6) 2010 with no high impedance message mentioned at this time. Clinic notes dated (b)(6) 2010 show "high impedance of 9220 ohms was detected. " diagnostics were performed on (b)(6) 2010, which resulted in high lead impedance. The pt was referred for lead revision at that time. During revision surgery, it was noted that the pt was stated to be a twiddler and the leads were observed to be "kinked" due to manipulation. Good faith attempts to obtain the explanted pulse generator and leads have been unsuccessful to date.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury. Pt manipulation is believed to be the likely cause at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1859789
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dennis100
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« Reply #4 on: July 18, 2017, 08:50:37 AM »

Model Number 303-20
Event Date 04/01/2012
Event Type  Malfunction   
Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.
 
Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.
 
Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.
 
Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.
 
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=2667369
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dennis100
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« Reply #5 on: July 18, 2017, 11:47:02 AM »

Model Number MODEL 250
Event Date 02/07/2013
Event Type Malfunction
Event Description
The physician reported that the handheld was not functioning after a sql error message was on the screen. Troubleshooting was performed, but did not resolve the issue. The handheld and flashcard were returned to device manufacturer for analysis; however, analysis has not yet been completed.

Event Description
Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution which confirms that the pin was not bent in the handheld prior to distribution and that the bent pin was likely a result of troubleshooting.

Manufacturer Narrative

Event Description
Analysis of the flashcard identified that pin 16 was bent, causing the flashcard to be unreadable by the handheld. The cause of the bent pin is unknown, but most likely caused while troubleshooting out in the field. Once the pin was straightened, the reported sql error was verified. The cause for the error is associated with an incomplete installation of the version 8. 1 software. The cause for the installation anomaly is associated with a potentially corrupt vns v8. 0 autorun. Exe file that was on the handheld. The autorun. Exe file was located in the 2577 folder of the handheld with a vns71. Arm. Cab file. This is unexpected behavior since the autorun. Exe file associated with the v8. 0 software is not typically transferred onto the handheld, but remains on the flashcard (the autorun. Exe file is transferred during a v7. 1 install, but not v8. 0 or v8. 1). The cause for the 2577 folder being on the handheld is associated with either an incomplete uninstall of the v7. 1 software during a v8. 0 upgrade or a v7. 1 flashcard being inserted into the handheld following a v8. 0 upgrade. A cause identifying why a v8. 0 autorun. Exe file was in the handheld 2577 folder could not be identified based on the available information. No other anomalies were identified during the analysis. Analysis of the handheld did not identify any anomalies associated with the sql error. The handheld performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2994723
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« Reply #6 on: July 18, 2017, 11:47:42 AM »

Model Number MODEL 250
Event Date 06/26/2007
Event Type  Malfunction   
Event Description
Reporter indicated that a flashcard would not seat properly into a dell handheld computer. The reporter removed the flashcard and examined the computer, noticing that one of the pins was bent. The handheld computer has been returned and product analysis is pending.
 
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=885323
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« Reply #7 on: July 18, 2017, 11:48:18 AM »

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

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

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3340158
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« Reply #8 on: July 18, 2017, 11:48:50 AM »

Model Number 302
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized; however, the sharp angle and a suspected lead break between the electrodes contributing to the high lead impedance cannot be ruled out.

Event Description
Our country rep for (b)(4) was contacted by a vns physician reporting a vns pt with high lead impedance on their system diagnostic and normal mode diagnostic testing. Prior to the pt's high impedance being attained, they participated in (b)(4) olympics. The pt's vns is not programmed off at this time. The pt is being referred for surgery to access the cause of the high impedance. One x-ray view was received for review. The alignment of the positive and negative electrodes appeared to be normal; however, the anchor tether did not appear to be on the vagus nerve. There appeared to be a suspected area between the positive and negative electrode as no lead could be visualized in this section; however, a lead break cannot be confirmed due to poor image quality. A strain relief bend and loop could not be assessed due to absence of neck x-rays and poor image quality. There appeared to be a sharp angle near the anchor tether; however, quality of image was poor and therefore, it cannot be confirmed. Only one tie-down was visualized. The filter feed-thru wires appeared to be intact. The generator is placed in the left chest in a normal orientation. The connector pin appeared to be fully inserted. The lead appeared to be intact at the connector pin and there was some lead behind the generator. Based on the x-ray received, no obvious fractures could be visualized; however, the sharp angle and a suspected lead break between the electrodes contributing to the high lead impedance cannot be ruled out. Good faith attempts will be made for product return if product is explanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872504
« Last Edit: February 04, 2018, 01:49:08 AM by dennis100 » Logged
dennis100
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« Reply #9 on: July 18, 2017, 11:49:24 AM »

Model Number MODEL 250
Event Date 02/01/2012
Event Type Malfunction
Event Description
Reporter indicated a vns dell x5 serial cable was causing intermittent communication problems. One of the teeth in the serial cable was visibly bent, and prevented a secure connection to the computer. Troubleshooting with the vns computer and programming wand identified the serial cable as the likely cause of the communication problems. Attempts for return of the serial cable are in progress.

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

Event Description
The computer serial cable was returned for analysis. During testing it was identified that the serial cable was unable to establish communication using a known good wand and handheld. The reason for the communication difficulties is associated with 2 bent pins in the dell axim connector plug; however, a cause for the condition is unknown. Once the pins were straightened, no further anomalies were identified. It was confirmed the bent pins in the handheld computer serial data cable caused a short circuit condition; following repair of the pins, full product functionality was restored.

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=2466354
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« Reply #10 on: July 18, 2017, 11:49:53 AM »

Model Number MODEL 250
Event Date 01/01/2013
Event Type Malfunction
Event Description
It was reported that the physician's handheld serial cable had bent pins at the wand connection and was loose at the handheld connection. A manufacturer representative attempted to bend the pin back to fit the wand connection back together, which was unsuccessful. The handheld and flashcard were returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

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=3360797
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« Reply #11 on: July 18, 2017, 11:50:26 AM »

Model Number 102
Event Date 06/30/2010
Event Type  Malfunction   
Event Description
On (b)(6) 2011, it was reported by a vns treating physician through clinic notes received by case management that the vns patient was being referred to have their pulse generator replaced due to eri= yes. The patient was experiencing a recent increase in seizure frequency and intensity, believed by the physician to be related to the dead battery. The patient had surgery on (b)(6) 2011 where the generator was replaced. During surgery the surgeon accidentally cut the lead, leading to replacement of the lead as well. The explanted products were returned to manufacturer for analysis. Analysis of the lead revealed no anomalies. Analysis of the generator confirmed the eri=yes condition, and was found to be due to normal battery depletion based on the electrical test results, and the battery life calculation. The generator was not at complete eos condition (defined at 2. 2v) as the measured battery voltage was 2. 378v. During analysis, a magnet (cyberonics pager style) was applied to the pulse generator, at distance of one inch, but the magnet current would not activate. However, at approximately 0. 75 inches from the pulse generator the output current ceased when the magnet was applied to the pulse generator and the magnet current activated after the magnet was removed from the pulse generator. The plastic housing over the reed switch (s1) was substituted with an external reed switch. The pulse generator module then performed according to functional specifications. The reed switch functions do not affect the supply current, so this observed reed switch condition should have no adverse effect on battery longevity. The failure mechanism for the reed switch (s1) was not ascertained. Additionally during analysis of the generator, a visual assessment on the feed-thru assembly, performed at the product analysis test bench, showed possible excessive bends in the positive feed-thru wire. In addition, separation of the silver polyimide to positive and negative feed-thru wire connections was observed. Verified at the bench, when either of the feed-thru wires (of the feed-thru assembly) were manipulated, the capacitance value was variable and periodically measured an open (electrically open) or 3. 7nf (limits are 2. 7nf to 5. 4nf). The most probable root cause for the backup capacitor tests was identified to be an open capacitor, which manipulation of the feed-thru wires may have been a contributing factor. The vns programming history database was reviewed for the patient's generator to review magnet activation history. There is diagnostic history available from the date of implant on (b)(6) 2006 up thru (b)(6) 2010, where all diagnostics were noted to be within normal limits. There was no indication in review of the history of any magnet mode diagnostics test results performed on this device. Review of the magnet activation history revealed that there were magnet activations recorded on (b)(6) 2008, indicating that the reed switch was functional for a period of time after the device was implanted. The most recent history was uploaded into the in house database in nov 2010, and the last magnet activation recorded was from (b)(6) 2008. The last interrogation setting available in house is dated (b)(6) 2008, where the magnet mode output current was programmed to 3. 25ma. Good faith attempts for additional information have been to no avail thus far. It is unknown if the patient was not using the magnet to initiate magnet mode stimulation, or if the reed switch failed at some point in time while implanted (after (b)(6) 2008). Review of the m102, sn (b)(4) manufacturing records was performed and all line items were signed off prior to distribution. All electrical tests and visual inspections were passed prior to shipment. If additional information is received, it will be reported.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death. Review of manufacturing records for the generator revealed that all line items were signed off prior to distribution and all electrical tests and visual inspections were passed prior to shipment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2090739
« Last Edit: July 24, 2017, 12:56:21 AM by dennis100 » Logged
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« Reply #12 on: July 18, 2017, 11:51:00 AM »

Model Number MODEL 250
Event Date 09/17/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury. Additionally while device failure occurred, the likely cause is user error/ mishandling of the device.

Event Description
Follow up was performed with the manufacturer's representative; however he was unable to say if the flashcard inadvertently inserted backwards before or during the upgrade attempt.

Event Description
It was reported by a representative, that during the upgrade of the physician's handheld he was receiving a message stating "unrecognized card, enter device driver for card. " or "enter name of device. " two different flashcards were tried with the same result. The software could not be installed, so the handheld was returned. Analysis on the handheld has since been completed. During the analysis it was identified that the vns software would not install into the handheld when the retuned flashcard was inserted. The cause for the anomaly is associated with 2 bent pins in the handheld flashcard slot. Once the pins were straightened, no further anomalies were identified. During analysis of the returned flashcards, no anomalies associated with flashcard software or databases were identified. The returned flashcards and software performed according to functional.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2785335
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« Reply #13 on: July 18, 2017, 11:51:31 AM »

Model Number MODEL 250
Event Date 08/01/2011
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that her handheld would not power on. The nurse first noticed on (b)(6) 2011 that the handheld would not power on even though she had charged it overnight. The nurse then tried two different electrical outlets known to successfully provide electrical power and tried to do a hard reset each time which did not resolve the problem. The nurse reported that she always keeps the handheld in the office at room temperature and was not aware of ever dropping it. The handheld and flashcard were returned to the manufacturer for product analysis which was completed on (b)(6) 2011. An analysis was performed on the returned handheld and the reported allegation that the handheld could not power on was not verified. No anomalies that could have contributed to the reported complaint were identified during the analysis. However, it was identified that one of the flashcard slot pins was bent. The cause of the bent pin is unknown, but is most likely associated with mishandling of the device. Once the pin was straightened, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2226503
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« Reply #14 on: July 18, 2017, 11:52:02 AM »

Model Number 250
Event Date 05/24/2011
Event Type Malfunction
Event Description
It was reported that the physician was having problems with his vns handheld computer. The handheld was on the beginning windows screen and would not progress to correct screen. A hard reset was performed and a screen that said "unrecognized card, enter the. ," and "unk card in socket 1" appeared. The handheld had previously undergone a software upgrade. Attempts for further info have been unsuccessful to date.

Event Description
The handheld and software were returned to the manufacturer and underwent analysis. Upon analysis, no anomalies were found with the software. An analysis of the handheld identified that 2 of the flashcard slot pins were bent preventing the flashcard from fully seating in the handheld device. As a result, the handheld was unable to read or write to the flashcard. The cause for the bent pins is associated with mishandling of the device. Once the pins were straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2175465
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« Reply #15 on: July 18, 2017, 11:52:30 AM »

Model Number 250
Event Date 07/27/2010
Event Type Malfunction
Event Description
An office nurse in (b)(6) reported to our company representative that they had a dell x50 handheld charging cradle that is no longer working - the pins in the cradle socket were reported to be bent. The cradle has been received by our country representative in (b)(4) and is pending shipment to the (b)(4) office.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824910
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« Reply #16 on: July 18, 2017, 11:52:58 AM »

Model Number 250
Event Date 04/29/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
A handheld serial cable was returned to the manufacture for an unk reason. An analysis was performed on the returned serial cable and visual analysis of the returned serial cable identified that pin 9 of the db9 connector was bent and touching pins 8 and 3. The cause for the bent pin is unk, but is most likely associated with mishandling of the device. Once the pin was straightened using a pair of pliers, no anomalies associated with the serial cable performance were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1818560
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« Reply #17 on: July 18, 2017, 11:53:25 AM »

Model Number 250
Event Date 10/01/2008
Event Type Malfunction
Event Description
It was reported to the manufacturer that the user's serial cable adapter cable's pins were bent at the connection site at the handheld. The cause of this event is unknown. Good faith attempts to obtain product back for product analysis have been unsuccessful to date.

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=1237662
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« Reply #18 on: July 18, 2017, 11:53:57 AM »

Model Number MODEL 250
Event Date 09/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns programming system would not communicate with patients' generators. Troubleshooting was performed on the system and the dell hhd serial connection was found to be loose and when manipulated, communication was successful. The hhd, serial adapter cable, and flashcard were returned and analysis was performed. No anomalies were found with the serial adapter or flashcard as they were performed according to specifications. During analysis of the hhd, it was identified that the hhd had communication difficulties. The cause for the communication difficulties was associated with a bent pin in the hhd serial connector. After the pin was straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

Manufacturer Narrative
H. 6. 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=927161
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« Reply #19 on: July 18, 2017, 11:54:25 AM »

Model Number MODEL 250
Event Date 07/01/2006
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 his vns therapy programming handheld was not operating properly, in that it would not properly load the vns therapy software. Handheld was hand-delivered to manufacturer product analysis. An analysis was performed on the handheld and the reported complaint was verified. Visual analysis identified that one of the flashcard slot pins were bent. The pin was most likely bent during the training process involving the removal and re-insertion of the flashcard. As a result of the bent pin, the flashcard would not be fully inserted into the handheld preventing the programming software from being installed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902192
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« Reply #20 on: July 18, 2017, 11:54:56 AM »

Model Number 300-20
Event Date 02/18/2011
Event Type Malfunction
Manufacturer Narrative
Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution. Device failure is suspected.

Event Description
Reporter indicated a vns pt was to have routine generator replacement surgery on (b)(6) 2011. Upon opening the generator pocket in the surgery, it was noted the lead pins were bent, and the pocket area appeared to be green and black in color. It was stated there was a possibility of infection, and only the generator was explanted at that time. The pt's vns lead was later explanted and a new vns system was implanted on (b)(6) 2011. An implant card received to the mfr stated it appeared the pt had a reaction to a lead fracture. The explanted devices have been returned for analysis with paperwork indicating the pt had manipulated the vns by pulling at the generator during a seizure. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063270
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« Reply #21 on: July 18, 2017, 11:55:31 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type Malfunction
Event Description
It was reported that the patient's device has not been able to be checked because the physician's handheld has not been working. Further follow-up with the physician identified that an error executing run app message was observed. Troubleshooting was performed by performing a hard reset, but the message did not resolve. The flashcard was removed and reinserted and the device was powered off and then back on; however, the same message was received. Another hard reset was performed and the issue did not resolve. No additional relevant information has been received to date.

Event Description
The handheld, flashcard, and programming wand were received for analysis. Analysis of the programming wand was completed on 02/27/2015. The programming wand performed according to functional specifications. Analysis of the handheld and flashcard are underway, but have not been completed to date.

Event Description
The handheld and flashcard are expected to be returned, but have not been received to date.

Event Description
An analysis was performed on the returned programming handheld and flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the handheld, it was identified that the handheld was unable to load the vns version 8. 1 software. The cause for the anomaly is associated with a bent pin in the flashcard slot. Once the pin was straightened, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.

Manufacturer Narrative

Manufacturer Narrative
New information received corrects the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4417857
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« Reply #22 on: July 18, 2017, 11:56:06 AM »

Model Number MODEL 250
Event Date 10/30/2014
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 programming system was unable to interrogate a known working generator. Troubleshooting was performed which identified that the physician's programming system was found to not interrogate. The physician was provided a new programming system and the handheld and wand were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis an intermittent power connection associated with the serial cable was identified. The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector. The cause for the bent spring is unknown, but is most likely associated with mishandling of the device. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the wand was completed on (b)(4) 2014. The returned battery was depleted and was not the recommended type per labeling (battery type labeling recommends alkaline). After the battery was substituted, the programming wand performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392435
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« Reply #23 on: July 18, 2017, 11:56:39 AM »

Model Number MODEL 250
Device Problem Device displays error message
Event Date 12/15/2015
Event Type Malfunction
Event Description
The handheld device and software flashcard were returned to the manufacturer for analysis which was completed on (b)(6) 2016 and identified that the vns software would not load when the returned flashcard was inserted. The cause for the anomaly was associated with a bent pin found in both the handheld flashcard slot and the software flashcard socket. Once the pins were straightened, no further anomalies the handheld and software flashcard were noted. Based on the information available, the root cause of the bent pin is most likely due to the user inserting the flashcard incorrectly. The manufacturer report capturing the software flashcard as the suspect device was reported in mfr. Report # 1644487-2016-00282.

Manufacturer Narrative

Event Description
It was reported that the vns physician handheld device displayed an "unrecognized card" error message. The flashcard was re-inserted and a hard reset was performed. After the "clear all data in memory" prompt was completed, the error message appeared again. The handheld device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5354854
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« Reply #24 on: July 18, 2017, 11:57:08 AM »

Model Number 250
Event Date 06/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the site was having problem with their handheld and they could not interrogate. It was indicated that one of the prongs of the serial adapter that goes into the wand was bent. After squeezing and wiggling the connection part, the site could finally get the programming system to work. New programming system was mailed to the site. Good faith attempts to get the handheld back to manufacturer for product analysis is unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1470053
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« Reply #25 on: July 18, 2017, 11:57:49 AM »

Model Number MODEL 250
Event Date 06/01/2007
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 a flashcard would no longer seat inside the dell handheld computer. The handheld was returned and an analysis was performed. Four bent pins were found which would obstruct the seating of a flashcard. No other anomalies or adverse findings were identified with the device performance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=883213
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« Reply #26 on: July 20, 2017, 03:42:41 AM »

Model Number 302-20
Event Date 02/17/2011
Event Type  Malfunction   
Event Description
Rptr indicated a vns pt had high lead impedance readings with vns diagnostics at an office visit. The vns was disabled and the pt was referred to a surgeon. The pt had no trauma and does not manipulate the vns. The pt's depression has increased since the vns was disabled. X-rays were reviewed by the mfr which did not identify any lead fractures, but a suspicious area in the lead was noted just inferior to the clavicle that appears possibly kinked or twisted, but not frankly fractured. The lead pin was fully inserted into the generator header. Based on the x-ray review, the cause of the high impedance is likely a lead fracture. As the lead pin is fully inserted, a lead pin issue has been ruled out and a lead fracture appears more likely as a cause for the high lead impedance. Vns revision surgery appears likely, but a surgery date has not been set.
 
Event Description
On (b)(6) 2011 additional information was received when the vns patient's husband reported that their insurance won't cover the replacement and they can't afford a new vns system. The husband stated that this is a life or death matter. The patient's mother then reported that patient's depression is worsening and they are all worried about her. The different options with regards to the cost of the surgery and implant were discussed with both the patient's mother and husband.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2040866
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« Reply #27 on: July 22, 2017, 03:42:16 AM »

Model Number 103
Event Date 02/03/2010
Event Type  Malfunction   
Event Description
The explanted generator was returned to mfr due to a prophylactic replacement. During analysis, the generator did not pass the final electrical test, and the measurement for the backup capacitor was out of specification. Further visual exam revealed that the negative feedthru wire was bent, and there was separation between the silver polyimide and feedthru wire. This separation can result in an open connection in the feed-thru capacitor. A review of the device history record verified that the generator passed the final electrical testing and qc inspections prior to shipment from the mfr. The intermittent feedthru capacitor connection can potentially cause erratic output delivery when in an mri electromagnetic field. There were no reports of any pt adverse events in this case.
 
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=2030812
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« Reply #28 on: July 24, 2017, 12:57:18 AM »

Model Number MODEL 250
Event Date 12/20/2012
Event Type Malfunction
Event Description
Reporter indicated that the pins located on the handheld computer were bent and that the flashcard was unable to be inserted. The physician indicated that there was nothing that could have occurred that would have caused the pins to become bent nor were there any accidental attempts to place the flashcard in the handheld backwards. The handheld was returned to device manufacturer for analysis on (b)(6) 2013; however, analysis has not yet been completed to date.

Event Description
Two flashcards were returned on (b)(6) 2013 and analyzed with the handheld. Visual analysis of the handheld verified that five of the flashcard slot pins were bent. The cause of the bent pins is associated with mishandling of the device. Once the pins were straightened, no anomalies associated with the handheld performance were noted. Analysis of the flashcards revealed that the 8. 1 version flashcard had 3 bent pins and as a result of the bent pins, the returned handheld would freeze when the flashcard was inserted. Once the electrical shorts were removed and the pins were repaired, not further anomalies were identified. The 8. 0 version flashcard had no anomalies associated and performed according to functional specifications.

Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2902159
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« Reply #29 on: July 26, 2017, 12:41:04 AM »

Model Number 302-20
Event Date 03/24/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns treating physician reported to the manufacturer's consultant that the vns patient presented with an increase in seizures and low impedance during a systems diagnostics test that day. The patient was sent for x-rays and refered to a surgeon. The physician reported that the low impedance could be due to "one of the wires being loose. " the patient's x-rays were received by the manufacturer for review on (b)(6), 2011. Based on the x-ray review, possible gross fractures or discontinuities could exist since the lead could not be fully assessed due to tight coiling from patient manipulation. Sharp angles existed in the lead body from patient manipulation and could also be the cause of the low impedance. Also, the electrodes were placed upside down, opposite of labeling, and there was no strain relief loop or bend; therefore unable to rule out as potentially contributing to the patient's low impedance. Whether the connector pin appeared to be fully inserted into the connector block could not be assessed based on the generator not being fully visible in the x-ray views available. Good faith attempts for further information from the physician have been to no avail thus far. No surgery has been scheduled as of yet and the surgeon the patient was referred to has no record of the patient. If additional information is received, it will be reported.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. 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=2074640
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