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dennis100
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« Reply #30 on: August 04, 2017, 07:56:56 AM »

Device Problem No Known Device Problem
Event Date 05/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A nurse reported that a patient began experiencing bruising on his left hand, difficulty moving his left arm, jerking in his left arm, and some pain. The patient's symptoms had reportedly begun after the patient's device had been programmed up to a certain level. X-rays were reviewed for the patient having these issues by a company representative and it was found that the patient's electrodes had been inverted during placement. No other anomalies were identified in the x-ray images. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724226
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dennis100
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« Reply #31 on: November 01, 2017, 01:12:39 AM »

Model Number 302-20
Event Date 08/25/2009
Event Type Injury
Event Description
It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.

Event Description
On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.

Event Description
Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.

Event Description
It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.

Manufacturer Narrative
Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.

Event Description
Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845774
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dennis100
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« Reply #32 on: November 05, 2017, 02:44:26 AM »

Model Number 304-20
Event Date 08/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the lead being placed on the nerve upside down was confirmed during lead replacement surgery. Further follow-up revealed that the patient requested that the vns be explanted due to ear pain. The patient's device was programmed off, but the patient requested explant. It was reported that despite the lead replacement. The patient claims to still have a buzzing noise along with severe constant ear pain. It was reported that device diagnostics have been within normal limits and there is no belief of device malfunction. There is no relationship of the vns to the patient't buzzing noise and ear pain. The patient underwent vns explant on 12/12/2014.

Event Description
Additional information was received stating that the vns patient was referred for surgery to explant her generator. The patient reportedly was hearing a buzzing noise from her device. The patient¿s generator has not been explanted to date.

Event Description
It was reported that the vns patient¿s lead was implanted upside-down on the patient¿s nerve. It is unclear how the physician made this determination. An implant card was received stating that patient underwent lead replacement surgery on (b)(6) 2014 due to lead failure. The explanted lead has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4110421
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dennis100
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« Reply #33 on: November 08, 2017, 01:48:28 AM »

Model Number MODEL 250
Event Date 10/27/2014
Event Type Malfunction
Event Description
The user of the tablet reported that it was not believed that the device had been dropped, and the reason for the cracked screen was unclear. An analysis was performed on the returned tablet, and the reported allegation was verified. A visual inspection of the tablet verified that the display was cracked. Also during the analysis, it was identified that the tablet would not power on. The cause for the anomaly is associated with the power button being installed upside-down. As a result, when the power button was pressed, the post on the power button was striking the power board led and not the on/off switch, preventing the tablet from powering on. Based on this information, it appears that the button was likely accidently removed while in the field, which may have been a result of potentially dropping the tablet or pulling up on the power button. Once the power button was removed and reinstalled, no further anomalies associated with the tablet were identified during the analysis.

Manufacturer Narrative
The initial report inadvertently did not report the following: it was reported that the user did not believe that the device had been dropped, and the reason for the cracked screen was unclear. Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Event Description
It was reported that the tablet device was shattered due to unknown reasons. The tablet device has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274103
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dennis100
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« Reply #34 on: November 16, 2017, 02:05:40 AM »

Model Number MODEL 250
Event Date 02/13/2015
Event Type Malfunction
Event Description
It was reported that during an attempt to upgrade the physician's tablet it was identified that the tablet would not power on after being plugged into a power outlet for approximately one hour. It was reported that the tablet power button would not move when depressed. A new tablet was provided to the physician. The programming tablet was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the tablet was completed on (b)(6) 2015. The cause for the anomaly is associated with an upside down power button. Once the power button was installed correctly, no further anomalies associated with the tablet were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4596683
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dennis100
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« Reply #35 on: November 26, 2017, 03:11:52 AM »

Model Number MODEL 250
Device Problems Image display error; Failure to power-up
Event Date 07/24/2015
Event Type Malfunction
Manufacturer Narrative
The udi # was inadvertently left of the original mfr. Report; (b)(4).

Manufacturer Narrative

Event Description
Product analysis was performed which showed the cause of the reported power on issues was associated with an upside down power button. Once the power button was installed correctly, no further anomalies associated with the tablet were identified. The dhr was reviewed and it was noted the device passed all functionality tests and inspection.

Event Description
It was reported that the physician's tablet would not power on. Once the tablet finally did power on, the screen was noted to be full of lines. The complaint tablet was received on (b)(6) 2015. The physician was provided a new programming tablet. Device analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027315
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dennis100
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« Reply #36 on: December 05, 2017, 01:10:21 AM »

Model Number MODEL 250
Device Problem Break
Event Date 10/23/2015
Event Type Malfunction
Event Description
Further analysis was performed and determined that the root cause of the previously observed inability to access the sd card was due to a cracked solder connection between the main board and a lead of the sd memory card socket. Once the lead was soldered onto the main mother board, no further anomalies were identified.

Event Description
A company representative indicated she had been given a tablet programmer from an unknown provider and that the tablet was broken. When the company representative checked the tablet, it did not appear broken. Attempts for additional relevant information have been unsuccessful to date. The tablet programmer has been returned to the manufacturer and is currently undergoing product analysis.

Event Description
During the analysis of the returned tablet programmer, it was identified that the tablet would not power on. The cause for the anomaly is associated with an upside down power button which had been incorrectly reinstalled by the user after shipment. After reinstalling the power button properly the unit was able to be powered on. It was identified that the tablet was unable to recognize the sd card but limited tablet programmer functionality such as interrogation, programming, and performing diagnostic testing, was confirmed. The cause for the anomaly is associated with a hardware failure on the main board. No software anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5238047
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dennis100
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« Reply #37 on: December 11, 2017, 02:52:51 AM »

Model Number MODEL 250
Event Date 01/26/2016
Event Type Malfunction
Event Description
It was reported that the physician's tablet had been charging for over 24 hours with the orange/red light visible on the tablet, but the tablet would not power on when the power button was pressed. Troubleshooting did not resolve the issue. A new tablet was provided to the physician and the faulty tablet was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the tablet was completed on 03/08/2016. The cause for the anomaly is associated with an upside down power button. Once the power button was installed correctly, no further anomalies associated with the tablet were identified during the analysis.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5450507
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dennis100
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« Reply #38 on: December 17, 2017, 01:21:45 AM »

Model Number MODEL 250
Event Date 05/05/2016
Event Type Malfunction
Event Description
It was reported that the tablet will not turn on. It was reported that the tablet is fully charged and no light could be seen when pressing the on/off bottom. It was confirmed that the power button was placed correctly. Review of manufacturing records confirmed all tests passed for the device prior to distribution. The suspect tablet was received by the manufacturer. Analysis of the device is underway, but it has not been completed to date.

Manufacturer Narrative
(b)(4).

Event Description
An analysis was performed on the returned tablet and the reported failure to power on was verified. The cause for the anomaly is associated with an upside down power button. Once the power button was installed correctly, no further anomalies associated with the tablet were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5687632
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dennis100
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« Reply #39 on: December 18, 2017, 01:42:23 AM »

Model Number MODEL 250
Event Date 04/18/2016
Event Type Malfunction
Event Description
It was reported on (b)(6) 2016 that one of the sites handheld devices is not turning on. The hand held, (b)(4) x50 screen is not turning on when the physician pressed the power button. It was confirmed that the screen lock buttons were not engaged and the battery cover was on and the battery cover lock was fully engaged. The physician stated that there is no power light when plugged in but when he holds the serial adaptor cable a certain way, it will flash orange. He then pressed the power button and it seemed that the hhd was coming on, but if he lets go of the serial adaptor cable then it went off again. The hhd would not turn on probably because the battery is depleted and can't get charged up because of the serial cable connection. The hand held device has not been received for analysis to date.

Event Description
The hand held and software were received for analysis on 06/01/2016. Product analysis for the hand held and software was completed and approved on 06/23/2016. An analysis was performed on the returned handheld and during the analysis an open electrical connection in the serial cable was identified. As a result, the handheld was unable to powered using the ac adapter. Also during the analysis it was identified that the main battery was installed backwards. As a result, the handheld was unable to charge and receive power from the battery. No further anomalies were identified. Analysis on the software was completed and no device issues were noted and the software performed according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5656791
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dennis100
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« Reply #40 on: December 18, 2017, 01:43:10 AM »

Model Number MODEL 250
Event Date 04/01/2016
Event Type Malfunction
Event Description
The tablet was received on 07/28/2016. An analysis was performed on the returned tablet and the reported allegation of "mechanical problem, failure to power on or off" was verified. The cause for the anomaly is associated with an upside down power button. It appears that the power button had been accidently removed while in the field. When the power button was replaced, it was replaced upside-down in the tablet. As a result, when the power button was pressed, the post on the power button was striking the power board led and not the on/off switch, preventing the tablet from powering on. Also the digitizer pen had a depleted battery. Once the power button was installed correctly and the battery was replaced in the digitizer pen, no further anomalies associated with the tablet were identified during the analysis.

Manufacturer Narrative

Event Description
It was reported that the physician's tablet was not turning on despite being charged with the cable. When the tablet was plugged in, the light on the side lit up. This confirmed that the tablet was charging but the tablet still wouldn't turn on when the power button was pressed. Information was later received that all the trouble shooting measures were taken. It was mentioned that the power button will not depress as it normally would. A replacement tablet was provided to the physician as a result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5656529
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dennis100
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« Reply #41 on: January 04, 2018, 01:50:43 AM »

Model Number MODEL 250
Event Date 01/01/2016
Event Type Malfunction
Event Description
The physician gave a livanova therapeutic consultant a hand held programming device (hhd) stating that it was not working. The therapeutic consultant was not able to get the hhd to turn on, even after charging it over night. The hhd was received on 11/17/2016. Analysis is underway, but hasn't been completed to date. No additional relevant information has been received to date.

Event Description
Per a livanova representative, the hand held computer was received with the battery cover from the physician, but the representative did not send the cover in for analysis. The battery on the hand held device was inserted backwards upon receipt from the physician by the livanova representative. It is believed that the battery being inserted backwards is likely the reason the hand held computer would not power on.

Event Description
It was discovered that a company therapeutic consultant returned the handheld programming computer without a battery cover. An analysis was performed on the returned handheld programming computer. During the analysis it was identified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Also, during the analysis it was identified that the main battery was installed backwards. As a result, the handheld was unable to charge and receive power from the battery. Once the battery was removed and installed correctly, no further anomalies were identified during the analysis. Analysis was performed on the flashcard software. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. No additional relevant information has been received to date.

Manufacturer Narrative

Manufacturer Narrative
Previous supplemental mdr #1 inadvertently did not include information received by a company representative who stated that the battery cover was received with the hand held programming computer from the physician, but was not sent in for analysis, and the battery was backwards upon receipt from the physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6140943
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dennis100
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« Reply #42 on: April 11, 2018, 02:32:51 AM »

Model Number 302-20
Event Date 05/14/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high lead impedance (dc dc ¿ 7). The patient¿s device settings were increased during the office visit. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in an abnormal arrangement. The second electrode appears to either be placed upside down or possibly has come off the nerve. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance may be due to detachment of the second electrode but no definitive conclusions can be made. Further follow-up revealed that the patient¿s device had been disabled and the patient still had good seizure control. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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=3857029
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dennis100
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« Reply #43 on: April 22, 2018, 12:44:21 AM »

Model Number 304-20
Event Date 04/29/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that high impedance was observed for this patient (impedance; 10. 000 ohms). The patient was recently implanted, and no trauma/manipulation was reported. The device was not disabled. X-rays were taken but have not been received. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
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.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient had generator and lead replacement and the explanted product were returned to the manufacturer for evaluation. When received, the ram and flash data were downloaded from the generator. The data in the diagaccumconsumed memory locations revealed that 3. 456% of the battery had been consumed. Visual examination showed tool marks on the pulse generator case and header most likely associated with manipulation of the device during the explant procedure. Burn marks were observed on the pulse generator case indicating that the pulse generator may have been exposed to an electro-cautery tool. The septum was not cored. No other surface abnormalities were noted on this device. An interrogation and system diagnostics test were performed, with a one inch spacer between the generator and the programming wand. Resulting status checks for; communication were ok, lead impedance and current delivered were normal for all diagnostic tests performed. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 974 volts as measured shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 3. 456% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator. The lead was returned for the allegation of explanted due to high lead break/high impedance. No obvious anomalies were noted. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The lead assembly was returned in two portions and the tie downs were not returned. On the returned 4234mm portion, setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. Continuity testing could not be performed during the decontamination procedure because the returned lead was not connected to a generator when received into pa. Incisions were made to allow for continuity checks. Abrasions were observed on the inner silicone tubes, but did not penetrate. Incision marks were observed on the inner silicone tubes and the marks penetrated the insulation and the quadfilar coils appeared to be kinked, in these areas. No discontinuities were identified during the continuity check. An analysis performed on the returned lead portions did not confirm the allegation. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance.
 
Event Description
Clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient was seen and complained of a vns system malfunction of high impedance. The patient felt he was not improving.
 
Event Description
X-rays were received on (b)(4) 2013. The generator was seen in the left chest area in normal orientation. The filter feedthru wires appear intact and the lead appears intact at the connector pin. The lead pin could not be seen past the second connector block indicating that it may not be fully inserted into the generator. The electrodes were observed in the neck, but do not appear to be in proper alignment. In the images it appears that the electrodes are placed in the opposite alignment with the positive electrode on the bottom, followed by the negative electrode on top. The lead is routed upwards from the electrodes then down toward the generator. No gross discontinuities or sharp angles were observed in the portion that could be assessed. Clinic notes dated (b)(6) 2013 indicated that the patient was seen for vns system malfunction of a high impedance error. The patient did not feel that he was improving, the patient¿s vns incisions were well-healed. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122782
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dennis100
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« Reply #44 on: May 14, 2018, 02:14:08 AM »

Model Number 250
Event Date 02/23/2009
Event Type  Malfunction   
Event Description
Initial reporter indicated that their (b) (4) handheld computer was having screen freezing issues. It was reported that it was suspected to be on the interrogation successful screen. The handheld computer contained 7. 1 programming software. The nurse at the site was asked to reseat the flashcard since screen freezes were a known event with x5 and 7. 1 programming software. The nurse was unable to get flashcard back out of the handheld computer. It was attempted multiple times with multiple people. It is believed flashcard was somehow installed in the handheld by being inserted upside down. Good faith attempts have been made for the product for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386188
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« Reply #45 on: May 14, 2018, 02:14:44 AM »

Model Number 103
Event Date 09/16/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing pain because her vns generator had "flipped. " the surgeon took x-rays and indicated that her vns was upside-down. The surgeon took her into surgery and readjusted the pt's generator. Diagnostics taken by a manufacturer representative on (b)(6) 2011 found no anomalies. Attempts for additional information are in progress.
 
Event Description
Additional information was received that the patient's vns was re-sutured by the surgeon and there have reportedly been no complaints since. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported that the patient came to the emergency department complaining that the generator was moving and causing pain. Device diagnostics were within normal limits. The patient underwent surgical revision at which time the surgeon moved the generator under the muscle to keep it from migrating. It was reported that a non-absorbable suture was used during the revision surgery in (b)(6) 2011. The physician believes that the patient manipulates the device through the skin. The surgery was performed for patient comfort.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301695
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« Reply #46 on: May 14, 2018, 02:15:31 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had a revision surgery on (b)(6) 2016. The generator found to be "completely floating around" in the generator pocket and was "upside down". It was reportedly loose enough that the surgeon could spin it in a circle. During the surgery, the surgeon observed that a tie-down was not attached and was re-attached. The generator was also re-secured, and more slack was given in the neck for the lead. In the previous generator implant, the surgeon reportedly did not place a suture to secure the generator. The patient did not have an issue with vns placement until the mammogram. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was reportedly still experiencing pain. The device was reported to still be set to not deliver current at the time the patient experienced the pain. No additional pertinent information has been received to date.
 
Event Description
Follow up with the office of the surgeon who performed the revision surgery showed that he likely used a suture to secure the generator in the previous generator replacement surgery. Attempts for additional pertinent information regarding the revision surgery have been unsuccessful to date. Further information showed that the patient was still experiencing pain and ¿shocking¿ sensations. The device was reported to be off at the time of this report. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient had her vns generator and lead explanted due to discomfort and painful stimulation. The explanted devices have not been returned to the manufacturer to date. No additional pertinent information has been received to date.
 
Event Description
Communication from the treating physician showed that the patient¿s pain had continued following cessation of stimulation. Settings and device diagnostic results were provided from the appointment where the device was disabled. The physician reportedly endorsed that the pain began following a mammogram procedure which pulled the vns lead. The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned lead portion. The returned portion measured 336 mm. The continuity measurements taken during decontamination verified an electrical and mechanical contact between the generator and the connector block to the end of lead. Visual analysis showed that the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at least at one time. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. Various electrical loads were attached to the pulse generator, and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 051 volts during functional testing and showed an ifi=no condition. The internal device data showed that 12. 492% of the battery had been consumed. Review of the remainder of the internal device data showed no anomalies. There were no performance or any other type of adverse conditions found with the pulse generator. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient was experiencing pain, device protrusion and generator migration following a mammogram procedure. The pain and protrusion were stated to be at both the lead and generator sites. The patient stated that she was thin and that her lead was always visible, but since the mammogram it protruded more than it had previously. A revision surgery was reported to have been scheduled at the time of the report, but has not been known to occur to date. No additional pertinent information has been received to date.
 
Event Description
The patient reported that the stabbing pain she previously reported was still present. Her vns was subsequently turned off. The pain in the neck was reported to have resolved with the generator disabled. The patient reportedly still experienced occasional sharp pain at the generator site not coinciding with stimulation. This pain cannot be predicted and does not appear to happen with any specific movement or body position. The patient expressed that she wanted the generator explanted. She feels the m106 generator is too large for her thin body. No known additional surgical intervention has occurred to date. No additional relevant information has been received to date. ¿.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5909344
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dennis100
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« Reply #47 on: May 14, 2018, 02:16:14 AM »

Model Number 103
Event Date 12/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient has been referred for generator revision surgery due to the device being "flipped" and migrated. The patient suffered trauma to the area and the device has moved. Clinic notes dated (b)(6) 2013 were received which indicated that after the patient was implanted with the vns in (b)(6) 2012, the patient was subsequently hospitalized with dvt (deep vein thrombosis) for which he was hospitalized and is on coumadin. The patient reported that his daughter grabbed his shirt and grabbed the vns which made it stick up on its side. Then the prior evening, for three hours, he worked to change the position of the vns and caused considerable chest pain in the process. The patient came in on (b)(6) 2013 for x-rays, he feels like the device is still functioning well. The physician reviewed the x-rays and stated that it appears that the patient has flipped the device upside down. The physicians stated that apparently he has either torn the suture or the attachment to the fascia working with manipulation of the device the night prior. The physician reported that the wire appears intact and on firm and feels like it is functional. The physician stated that they will re-open the patient and re-anchor the generator. It was stated that no further information would be provided by the physician. The patient was scheduled for surgery on (b)(6) 2013 but it is unknown whether the generator was replaced or if the implanted generator was just sutured back in place.
 
Event Description
Additional information was received on (b)(4) 2013 when it was reported that during surgery, the generator was just re-sutured down and was not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043887
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dennis100
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« Reply #48 on: May 14, 2018, 02:17:03 AM »

Model Number 103
Event Date 08/20/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem; corrected data: inadvertently stated "on (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time" instead of "on (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time" on supplemental report #1.
 
Event Description
On (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time.
 
Event Description
On (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time.
 
Event Description
It was again reported that since his vns implant, the patient has had serious stomach issues and has lost a considerable amount of weight. The patient, however, has had an improvement in seizure reduction. The patient was noted to have had persistent vomiting, changes in appetite, and weight loss.
 
Event Description
Additional information was received on (b)(4) 2013 when it was reported that the patient had a follow-up visit with her nurse practitioner that day. The first interrogation of the device indicated that the device was "off, the output current was 0. 0ma, however the magnet output current was at 0. 25ma. The vomiting has "slowed up some" since (b)(6) 2012 and the patient has lost 40 pounds and has little appetite. There were 3,746 magnet activations captured on the device. The device was then programmed "on" to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec. System diagnostics were "ok" and the ohms was noted to be 3,580ohms.
 
Event Description
Additional information was received on (b)(6) 2013, when it was reported that the patient had the vns device turned off over a month ago by the surgeon because of vomiting. There are no plans to turn it on until the patient sees a gastro physician.
 
Event Description
It was reported that shortly after the patient's vns stimulation was enabled immediately following initial vns implant surgery, the patient began vomiting. The physician indicated that he was unsure if the vomiting was occurring with stimulation, but he indicated it was likely. The patient was noted as not vomiting when the family swipes the magnet over the generator to activate extra stimulation to abort a seizure. The patient's family believes the patient is having a sensation in his stomach however the patient is nonverbal. The patient's vns was disabled for 3-4 days however when the stimulation was re-enabled, the patient was vomiting so much he became dehydrated and had an increase in seizures requiring hospitalization as a result. Vns diagnostics had not been run since surgery which were noted as within normal limits at that time. The patient's vns has been turned back off for the time being. Follow-up with the patient's neurologist found the patient has a dental abscess which she and the surgeon believe may be contributing to the vomiting with stimulation. They have asked the patient to have resolved and then they will resume vns stimulation. No medication changes were believed to have caused or contributed to the events. Attempts for the missing product information are in progress.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vns patient has lost 40 pounds and is vomiting. The patient's device was shut off except for the magnet settings. The physician questioned whether the leads could possibly be placed upside down. The patient was stated to have profuse vomiting when the device is on. It was reported that the patient's device has sporadically been on and off based on the patient's vomiting events. Currently the physician is thinking about turning the magnet mode off as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766219
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dennis100
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« Reply #49 on: November 15, 2018, 08:26:31 AM »

Model Number 304-20
Event Date 01/10/2013
Event Type  Injury  
Manufacturer Narrative

Event Description
It was initially reported that the patient went back into surgery following implant. The surgeon believed that he placed the electrode on the nerve upside down and took the patient back in to surgery to correct the placement. Diagnostics were within normal limits at implant surgery and were within normal limits following the electrode placement correction. There were no adverse events, the surgeon simply recalled that he placed them upside down and schedule the patient for surgery to correct them. There were no x-rays taken to confirm the event prior to the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2942632
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dennis100
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« Reply #50 on: January 09, 2019, 08:55:44 AM »

Model Number MODEL 250
Event Date 02/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the handheld device was most likely dropped or misused and the button may have been repositioned incorrectly.
 
Event Description
It was reported that the physician's tablet does not power on when the power button is pressed. It was reported that the tablet charges, but does not power on. Troubleshooting performed by a company representative identified that the power button did not feel like it was engaging when pressed. It was reported that the physician has two other tablets so no patients were affected by this. The tablet was returned for analysis. Analysis of the tablet was completed on (b)(4) 2014. During the analysis, it was identified that the tablet¿s power button was installed upside down. As a result, when the power button was pressed, the post on the power button was striking the power board led and not the on/off switch. Further analysis of the power button also identified that one of the legs were bent. The bent leg allowed the power button to be loose inside the tablet and also made it easy to remove (as compared to a known good tablet). This condition most likely allowed to power button to be accidently removed from the tablet. When the button was replaced, it was most likely positioned upside down. No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677268
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