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dennis100
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« Reply #30 on: December 20, 2018, 01:32:26 AM »

Model Number 103
Event Date 12/19/2014
Event Type  Injury   
Event Description
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On 03/11/2015 it was reported that the physician lacerated the carotid artery of the patient during the re-implant surgery. A vascular surgeon was called in to assist. After 7 hours, the patient appeared to be stable and was sent to the icu to stay the evening.

Event Description
It was reported that the patient developed an infection at the generator site and would undergo generator explant. It was reported that the surgeon would clean the generator pocket and then making a new generator pocket and implanting another generator. It was later reported that the patient presented to surgery with a badly infected generator pocket with an open wound and the generator missing. It was reported that the lead was sticking out of the pocket with the lead pins torn off. It was presumed that the lead pins were still connected to the missing generator. The surgeon decided to explant the lead and let the mrsa infection heal before re-implanting in 2-4 weeks. It was reported that the patient did not know what happened to the generator. The surgeon indicated that the chest wound broke down and extruded. The patient initially had a seroma, but that the generator eventually extruded through the skin. No additional relevant information has been received to date.

Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532501
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dennis100
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« Reply #31 on: January 01, 2019, 04:41:28 AM »

Model Number MODEL 250
Event Date 10/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the physician complained that he was having intermittent communication issues with various patients using the programming system and screen freezes that were resolved with resets. It was not clear when the screen freezes would occur. The physician was said to be "fed up" and wanted a new system. Per the physician, the issue was occurring for a few months; however, it was not previously reported to the manufacturer. Review of the device history records indicate no unresolved non-conformance issues were present. The physician was sent a new programming system. No other information has been provided.
 
Event Description
The handheld and related software/flashcard is unable to be located. Therefore, it is lost and will not be returned to cyberonics.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3554857
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dennis100
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« Reply #32 on: January 09, 2019, 08:29:24 AM »

Model Number MODEL 250
Event Date 02/10/2014
Event Type  Malfunction   
Event Description
It was later reported that the site no longer has the handheld and that it appears to have been lost. The physician could not recall any specifics about the problems he was having with the handheld.
 
Event Description
It was reported by the neurologist that he was having problems with his handheld. Troubleshooting was performed but was unsuccessful. The neurologist had to use his partner¿s handheld to complete the appointment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3674085
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dennis100
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« Reply #33 on: January 15, 2019, 01:21:06 AM »

Model Number MODEL 250
Event Date 04/23/2014
Event Type  Malfunction   
Event Description
The programming tablet is expected to be returned to manufacturer for analysis, but has not been received to date.
 
Event Description
It was reported that the neurosurgeon¿s tablet device could not be connected to the programming wand because the connection had been stripped and was no longer tight. The tablet device is expected to be returned to the manufacturer but has not been received to date.
 
Event Description
On (b)(6) 2014, it was reported that an exhaustive search of the reporting facility was unsuccessful in locating the suspect medical device. The device is not expected for return at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821329
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dennis100
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« Reply #34 on: January 19, 2019, 02:33:16 AM »

Model Number MODEL 250
Event Date 05/13/2014
Event Type  Malfunction   
Manufacturer Narrative
The handheld cannot be located and therefore will most likely not be returned.
 
Event Description
Additional information received revealed that the handheld cannot be located and therefore it is unlikely that the handheld and associated flashcard will be returned for analysis.
 
Event Description
It was reported that the neurologist was having issues with his handheld device. When attempting interrogation, the interrogation progress bar would appear but never successful completed the interrogation. The handheld device would not go past the interrogation successful screen. The programming wand was used with a tablet device and was able to successfully perform interrogations. The hard reset was performed on the handheld device but the issues were not resolved. The handheld device and software flashcard have not been returned to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855669
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dennis100
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« Reply #35 on: January 20, 2019, 01:14:09 AM »

Model Number MODEL 250
Event Date 01/14/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the physician's handheld was showing an error that the flashcard is unable to be recognized. A hard reset was performed, but the error showed up right after the dell screen. The flashcard was removed, and it was observed that a few of the pins in the flashcard slot were visibly bent. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Manufacturer Narrative
Manufacturer reviewed device history records. Review of the handheld device history records confirmed all quality specifications were passed prior to distribution.
 
Event Description
The physician's office reported that they no longer have the handheld device, and the location/disposition of the device is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3623251
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dennis100
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« Reply #36 on: January 23, 2019, 01:47:08 AM »

Model Number MODEL 250
Event Date 06/10/2014
Event Type  Malfunction   
Event Description
It was reported that there were communication issues with the programming system. The wand battery was replaced and the handheld was unplugged from the wall socket. The communication issues resolved when the serial cable was held in a specific orientation. The handheld serial cable has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr omitted that the new serial cable did not resolve the issue.
 
Event Description
The products are not expected for return as they are believed to be lost.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913621
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dennis100
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« Reply #37 on: January 24, 2019, 03:39:20 AM »

Model Number 105
Event Date 07/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator implant, the rubber septum plug over the set screw popped out when the surgeon was tightening the set screw. It was reported that the plug fell out of the sterile field. The plug was unable to be located within the or and a new generator was implanted. It was reported that the physician did not use any excessive force that may have caused the plug to come off. It was reported that the plug popped out easily as if it was not attached. The generator was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4042354
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dennis100
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« Reply #38 on: January 30, 2019, 08:56:25 AM »

Model Number MODEL 250
Event Date 08/18/2014
Event Type  Malfunction   
Event Description
Additional information was received indicating that the replacement serial cable had solved the reported programming issues. The suspect serial cable was lost; therefore, no analysis can be performed.
 
Event Description
It was reported that the physician's handheld was having intermittent trouble and that it would sometimes interrogate patient's generators and sometimes it would not. Additionally, it was reported that occasionally device diagnostics would not complete. A known working wand was connected to the handheld and the problem persisted indicating a possible handheld or handheld serial cable issue. It was reported that the message "failure to receive all bytes in sequence message" was seen. The physician has several programming systems and no patient's were affected by this issue. A new serial cable was provided to the physician. No additional relevant information has been received to date. The serial cable is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089126
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dennis100
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« Reply #39 on: February 06, 2019, 01:27:02 AM »

Model Number 302-20
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value = 10,000 ohms). A few months prior to the observed high impedance condition, the patient was experiencing shocking sensations at his neck which had recently resolved. No known surgical interventions have occurred to date. X-rays were taken and were reported by the physician to be unremarkable. 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. 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.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2015 to explant his device. The patient¿s family elected not to replace the system as the patient had been seizure-free for over a year. The explanting facility misplaced the explanted devices and was unable to return the devices to the manufacturer; therefore, no analysis can be performed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by 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=4348113
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dennis100
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« Reply #40 on: February 14, 2019, 01:06:58 AM »

Model Number TABLET MOT
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
Information was received from a company representative on 05/14/2015 that the cable is lost and will not be returned. The replacement cable resolved the issue.
 
Manufacturer Narrative

Event Description
It was reported that the physician's tablet usb cable was not working. A replacement cable was provided to the physician. The malfunctioning usb cable is expected to be received for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641096
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dennis100
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« Reply #41 on: February 14, 2019, 01:07:55 AM »

Model Number TABLET MOT
Event Date 03/06/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's office is unable to locate the tablet usb serial cable at this time. The cable has not been received to date.
 
Event Description
It was reported that the nurse practitioner's tablet was giving an "unable to open port" error message. A new usb cable was provided to the nurse practitioner. The malfunctioning usb cable is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4645343
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dennis100
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« Reply #42 on: February 14, 2019, 01:08:57 AM »

Model Number MODEL 250
Event Date 03/03/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Information was received from a company representative on (b)(6) 2015 that the tablet serial cable is lost and will not be returning to the manufacturer for analysis.
 
Event Description
It was reported that the company representative's programming system was unable to program a patient's device off. Troubleshooting was performed which identified that the programming wand was not functioning. The company representative was provided a new programming wand and the nonfunctional wand was received for analysis. It was later reported that the issue remained with the new programming wand. The company representative indicated that the "unable to open port" error message was still being received indicating a possible problem with the usb cable that connects the wand and tablet. The company representative was provided a new usb cable. The nonfunctional usb cable is expected to be returned for analysis, but has not been received to date. Analysis of the programming wand was completed on 03/26/2015. No visual or mechanical anomaly was identified. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638077
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dennis100
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« Reply #43 on: February 18, 2019, 01:06:25 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the explanted devices cannot be returned for product analysis as the hospital could not locate them.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had the vns generator and lead explanted on (b)(6) 2013 due to the patient lack of efficacy and pain at the sites. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444251
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dennis100
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« Reply #44 on: February 25, 2019, 01:25:14 AM »

Model Number MODEL 250
Event Date 04/17/2015
Event Type  Malfunction   
Event Description
The tablet was returned to the manufacturer. An analysis was performed on the returned tablet and it was noted that the device did not have the power button. No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the power button of a medical professional¿s tablet had detached from the device and it was lost. The tablet could not be switched on afterwards. Device manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The tablet has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4764437
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dennis100
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« Reply #45 on: March 02, 2019, 03:33:13 AM »

Model Number MODEL 250
Device Problem Device Displays Incorrect Message
Event Date 06/27/2015
Event Type  Malfunction   
Event Description
Additional information was received that the suspect serial cable was lost and is no longer available for return and analysis.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the manufacturer's sales representative was unable to program his demonstration generator with his programming system. He received an 34 error in establishing communication 34 message. Troubleshooting was performed by using another programming wand which successfully programmed the demo generator. The wand 39 s 9v battery was checked and was seen to be fully charged. There was no obvious damage to the usb to db9 serial adapter cable. The adapter cable and wand were tested on another tablet, and the same 34 error in establishing communication 34 message appeared. A new programming wand was sent to the sales representative and the error continued. Thus, a new adapter cable was sent to the sales representative which reportedly resolved the issue. The suspect adapter cable has not be received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4936444
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dennis100
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« Reply #46 on: March 05, 2019, 05:14:49 AM »

Model Number MODEL 250
Device Problem Device Displays Incorrect Message
Event Date 07/31/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that an "unable to open port" message was seen on a physician's tablet programmer. The sales rep replaced the usb cable and had no further issues. The serial cable is expected to be returned but has not been received for analysis to date.
 
Event Description
The sales representative states that she returned the serial cable for analysis but the device has still not been received to date. There is no tracking number available for the return of the device and the device has not been received to date. The cable is likely lost and not returning at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5028855
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dennis100
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« Reply #47 on: March 13, 2019, 12:37:40 AM »

Device Problem Device Displays Incorrect Message
Event Date 08/15/2015
Event Type  Malfunction   
Event Description
The suspect handheld and software have been determined to be lost at this point. The products were reportedly sent back via fedex but were never received by the manufacturer for analysis to date.
 
Manufacturer Narrative

Event Description
It was reported that the physician received an error message on his vns programmer. No additional relevant information has been obtained to date. The suspect handheld and software have not been received by the manufacturer for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5072983
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dennis100
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« Reply #48 on: March 17, 2019, 02:38:09 AM »

Model Number 304-20
Device Problems Low impedance; Component Missing ; Material Protrusion / Extrusion; Lead
Event Date 11/04/2015
Event Type  Malfunction   
Event Description
It was reported that a low impedance warning was received during diagnostic testing of a patient's generator. The patient had a bandage over his generator incision site. The patient underwent exploratory surgery to determine the cause of the low impedance. When the bandage was removed from the generator incision site, a portion of the lead was sticking out of the generator incision. Two surgeons spent 1. 5 hours searching for the rest of the lead, but they were unable to find it other than a small portion of one of the coils in the neck. There was an infection present at the generator site, so the surgeons decided to remove the generator and remaining portion of the lead that was attached to the generator. X-rays and ultrasound confirmed that no lead was present. The surgeons believed that the patient pulled the lead out of his body through the generator incision site. The device history record for the lead was reviewed, and the lead was sterilized prior to release. Attempts for further information regarding the infection were unsuccessful to date. The explanted generator and remaining portion of the lead have not been received to date. The patient has not had a new vns system implanted to date.
 
Event Description
Analysis was completed on the generator on 01/11/2016. The generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The explanted generator and remaining portion of lead were received on 12/14/2015. Analysis on the lead was completed on 01/05/2016. The portion of the lead containing the manufacturing id tag was not returned, thus the model and the serial number of the returned lead portion could not be verified. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis has not been completed on the generator to date.
 
Event Description
The cause of the infection was the patient picking at the incision site until it opened up and exposed the lead. It has been planned to replace the vns system in the future with the generator implanted on the patient's back. The patient has not had re-implant surgery to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5252502
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dennis100
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« Reply #49 on: March 19, 2019, 12:27:40 AM »

Model Number HHD, DELL
Device Problems Cable; Component Incompatible; Component Missing
Event Date 09/25/2015
Event Type  Malfunction   
Event Description
It was initially reported by the physician's office that some of the cables for the handheld programming system were lost and the device was not able to be used without the cables. It was later reported on the returned product form that the cord is older and does not work and that the tablet programming system does not have cords that match the handheld programming system. The handheld programming system was received on 10/26/2015 but it was discarded upon receipt as there was initially no report of a complaint, only that the cords were lost and that the programming system was unable to work without the cords. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
The aware date was incorrectly reported on the initial mfr. Report. Information found in mfr. Report # 1644487-2015-06185 was found to be duplicate information of this mfr. Report. Based on this information, the aware date was updated and the report is now housed in this mfr. Report. This information was inadvertently left off of the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5241802
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dennis100
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« Reply #50 on: March 20, 2019, 10:11:45 AM »

Model Number MODEL 250
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally; Application Program Problem
Event Date 10/16/2015
Event Type  Malfunction   
Event Description
It was reported by the physician that the tablet "freezes up". However, the company representative's demo generator was able to be interrogated and the physician's tablet worked without difficulties. The physician was not able to state what error message he saw and requested a replacement tablet. The physician's tablet was not replaced, but he was given a new serial cable. Since the time the physician received the new serial cable, the physician's programming system has worked as expected. The complaint serial cable is expected to be returned but has not been received by the manufacturer to date.
 
Event Description
The complaint serial cable has not been received by the manufacturer to date and is believed to be lost. As the complaint serial cable is no longer expected to be returned, no product analysis will be able to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5214243
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« Reply #51 on: March 21, 2019, 12:06:26 AM »

Model Number MODEL 250
Device Problems Battery; Housing; Component Missing
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a physician's hand held is missing a battery cover. The system will be returned and the physician requested a new tablet that can be upgraded to be sent to him. The physician cannot find the missing battery cover. It was stated from the sales representative that the functionality of the device was compromised due to the missing battery cover. The hand held was received for analysis on 11/02/2015. Analysis is underway but has not been completed to date.
 
Event Description
Product analysis for the handheld was completed and approved on 12/02/2015. The handheld was received with a battery cover. During the analysis it was identified that the handheld was unable to advance past the welcome screen. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. Product analysis for the software 8. 1 was completed and approved on (b)(6) 2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. It is unknown why the returned handheld had a battery cover as it was confirmed from the sales representative that the handheld was given to him without a battery cover and this was the same handheld returned. It was confirmed that the returned handheld did belong to this physician as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225199
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dennis100
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« Reply #52 on: March 23, 2019, 12:20:36 AM »

Model Number 103
Device Problems Device Operates Differently Than Expected; Programming Issue
Event Date 11/25/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was seen by the physician and the vns showed ifi=yes. The physician stated that he has the patient at a 49% duty cycle but doesn't think the battery should be dying so soon. A battery life calculation (blc) was performed which showed 4. 1 years remaining until neos=yes. However, the most recent line of programming history was from (b)(6) 2013 which showed the device programmed to output=1ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=1. 1min which is not a 49% duty cycle and therefore the patient's settings have since been adjusted and the blc may not be accurate. Additional programming history was requested from the physician but has not been received to date.
 
Event Description
A copy of the physician's flashcard was received but it could not be read. Good faith attempts were made for another copy of the physician's flashcard but a copy has not been received to date. Clinic notes dated 12/14/2015 were received for review which indicated that the recent testing of the vns showed ifi=yes.
 
Event Description
On (b)(6) 2016 it was reported that the patient underwent prophylactic generator replacement. The explanted generator could not be returned for product analysis as the device was in the therapeutic consultant's bag that was stolen.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5306719
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« Reply #53 on: March 24, 2019, 01:08:46 AM »

Model Number 302-20
Device Problem High impedance
Event Date 11/13/2015
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2015 note that high impedance was observed (>10,000 ohms). It was noted that the seizure control remains good and that the patient would be referred to neurosurgery. No known surgical interventions have been performed to date.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement. It was reported that the explanted devices were lost; therefore, no product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5285539
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dennis100
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« Reply #54 on: March 24, 2019, 01:09:39 AM »

Model Number 103
Event Date 07/18/2014
Event Type  Death   
Event Description
It was reported by the neurologist that the patient had passed away on (b)(6) 2014. It was stated the neurologist had no further information. An obituary search was performed and the nursing home where the patient passed away was found. Attempts for information were made to the nursing home; however, they stated they were unable to find that patient's chart. Attempts for further information have been unsuccessful to date.

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dennis100
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« Reply #55 on: March 31, 2019, 06:40:43 AM »

Model Number 250
Event Date 02/08/2016
Event Type  Malfunction   
Event Description
It was reported the physician was having a difficult time using his programming wand. It was later reported the company representative was having trouble interrogating a patient with the physician's handheld device. Troubleshooting was performed and it was found the battery cover on the wand was broken and originally thought to be the issue; however, this was ruled out as the physician had used the same handheld device with a new wand earlier in the date. Additional troubleshooting was performed and showed handheld device was able to be charged using a known working power cord. The handheld device was working properly after being charged. The faulty power cable was received by the manufacture. Analysis is expected; however, it has not been completed to date.
 
Event Description
Product analysis for the returned ac power adapter cabled was completed. Analysis was performed on the ac adapter; however, no anomalies associated with the ac adapter performance were noted during testing. The ac adapter performed according to functional specifications. The programming wand was reported to be lost and is not expected to be returned for analysis.

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dennis100
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« Reply #56 on: April 02, 2019, 12:08:35 AM »

Model Number MODEL 250
Event Date 04/19/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that the power button on a physician's tablet had come off and was lost. The device turned on when the metal connector in the hole where the power button used to be were pushed with a pen. The programming system has not been received for analysis to date. Additional relevant information has not been received to date.
 
Manufacturer Narrative
Event description, corrected data: the event description inadvertently stated that the device had not been received for analysis. Device evaluation, corrected data: the field was inadvertently provided as not having been received by the manufacturer in the initial report.
 
Event Description
The tablet was received for analysis on 04/29/2016, which is underway but has not been completed to-date.
 
Event Description
Analysis was completed on the returned tablet 06/07/2016. Visual analysis of the tablet was able to verify that the power button was missing. Further analysis also identified that the low profile tactile switch on the power board was damaged. When the power button is pressed, it applies pressure to the tactile switch and powers on the tablet. No further anomalies were identified.

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dennis100
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« Reply #57 on: April 13, 2019, 03:27:21 AM »

Model Number 304-20
Event Date 06/30/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that low impedance was observed at office visit on (b)(6) 2015. A subsequent diagnostic test was performed during the same visit and resulted with normal impedance levels. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the low impedance reading. Review of the programming data that captured the low impedance found that when the low impedance message presented the actual impedance value was measured as 384 ohms. Further follow-up found that the generator was still presenting with a low impedance message during a visit on (b)(6) 2016. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was experiencing a funny sensation in the neck and throat; which was attributed to vns stimulation. This change in perception was noted at the same time that the low impedance was observed and therefore appears to be related. The patient was referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent vns lead and generator replacement surgery. In pre-op, diagnostic testing resulted within normal limits. During surgery the surgeon observed approximately 1 inch of the lead insulation was stripped off of the lead. The missing piece of the lead insulation could not be located. The lead and generator were then explanted and later received by the manufacturer. Both products are currently pending product analysis.
 
Event Description
Product analysis on the generator was completed. During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed. The generator performed to functional specification.
 
Event Description
Product analysis was completed on the received lead portions. It was noted that the portion of the lead with the electrodes was not received therefore a complete evaluation could not be performed on the entire lead. The lead was received in 4 portions with the segment containing the lead connector pin still inserted into the generator. A continuity measurement verified electrical and mechanical contact between the generator and the lead pin. X-rays were taken and revealed that the canted spring of the generator was making contact with the connector ring of the lead. The continuity of the lead portions were evaluated and no discontinuities were identified within each portion. During analysis it was observed that the outer and inner silicone tubing had abrasions which would have made it possible for the quadfilar coils to come in contact with each other which would have caused a short circuit condition that would result in low impedance. Bodily fluids were observed inside the inner and outer tubing and coil fractures were observed in multiple areas however pitting was not observed. Analysis determined that the mechanism for some of the fractures appeared to be stress induced. However the mechanism for all of the fractures could not be determined. Based on the results of analysis it appears that the cause of the low impedance is related to a short circuit condition in the lead.
 
Event Description
It was reported that the patient experienced discomfort when the lead and generator were implanted.

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dennis100
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« Reply #58 on: April 13, 2019, 03:28:04 AM »

Model Number 303-20
Device Problem Difficult to Insert
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block. It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator. The grub screw was lost out of the head and both lead and generator had to be replaced. It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect. No further information was provided to date.
 
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis. It was reported that when the reported issue was found, another device was implanted instead. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.
 
Event Description
The suspected generator and lead were returned to the manufacturer on 09/26/2016. An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed. The connector pin section including the small front o-ring and large o-rings was not returned. A portion of the connector boot was returned. The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure. No obvious anomalies were noted. Continuity checks of the returned portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a product anomaly with the returned portions of the lead which may have contributed to the stated complaint. An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0. 136 inches minus (limits 0. 137 +/- 0. 002). The pulse generator header lead cavity, critical dimension 1, meets specification. In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016). The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016. This would suggest the lead pin was inserted into the pulse generator header. The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory. The septum was cored and damaged on the underneath side. This suggests that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) set screw". The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 0. 767% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of. 135 max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. Review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication. No further relevant information has been received to date.

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« Reply #59 on: April 14, 2019, 01:04:13 AM »

Model Number 106
Event Date 07/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the physician was in the process of implanting the patient with a new generator when the septum plug became detached from the generator and was lost. The physician also reported that the set-screw wasn't tightening prior to the septum plug becoming detached. It was confirmed that the septum plug was lost outside of the patient. The generator was received on 07/29/2016. Analysis has not been approved to date.
 
Event Description
Analysis was approved on 08/25/2016. The returned setscrew showed mechanical wear at the socket (suggesting numerous insertion attempts), but the socket was not stripped. The underneath side of the returned setscrew showed indention marks: suggesting a lead pin or test resistor was once secured by the setscrew and; the indention mark on the slanted edge of the setscrew suggests the setscrew caught the edge of the lead pin or test resistor. In addition, the returned setscrew showed mechanical wear on the threads. The mechanical wear on the returned setscrew threads (and based on the scratches / tool marks observed on the negative connector block) suggests re-insertion attempts of the returned setscrew. The negative connector block showed mechanical wear on the flat surface, at the edge before the threads. In addition, scratches and or tool marks (from an unknown source) were observed on the lead pin channel of the negative connector block, which is atypical to what is normally observed in the analysis lab. The septum was not returned for evaluation. The header septum cavity met specification requirements. Therefore, a root cause for the conditions could not be determined. A bench setscrew was inserted into the negative connector block and secured a bench in-line lead, which fully inserted into the generator header past the negative connector block (lab conditions). The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. Other than the mechanical wear and scratches/tool marks on the negative connector block, there were no performance or any other type of adverse condition found with the pulse generator.

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