Pages: 1 ... 22 23 [24] 25   Go Down
Print
Author Topic: Chest Pain  (Read 220818 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #690 on: December 07, 2018, 11:35:07 AM »

Model Number 103
Event Date 03/19/2013
Event Type  Malfunction   
Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002
« Last Edit: December 16, 2018, 09:29:47 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #691 on: December 08, 2018, 02:46:35 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2007
Event Type  Injury  
Manufacturer Narrative

Event Description
It was reported that the patient's vns had been removed in the past due to having pain and to no longer having seizures. Follow up with the patient's neurologist confirmed the date of vns explant, that the pain occurred in the left upper anterior chest over the site of the vns, and that it was assessed to be caused by the presence of the vns device. The pain reportedly began sometime in (b)(6) 2007, and it was noted that the device was disabled sometime in 2005. The explanted device had not been received by the manufacturer to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8043736
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #692 on: December 08, 2018, 02:48:08 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury   
Event Description
The patient's mother reported that the patient had been in the hospital due to vomiting, gagging, pain under each arm, hiccups and hypotension. The patient's vns was disabled for 24 hours in the hospital. When the device was off, there was no gagging and vomiting. When it was turned back on, the gagging and vomiting was less. The patient had reportedly lost 5 pounds since the vomiting started. After a full gi work-up, nothing but gastric irritation was found. The treating physicians in the hospital didn't think that the vns was the cause, but they wanted to further investigate and confirm this. The patient's mother reported that the treating physician said that her daughter was using the magnet too often. The patient was in the hospital for approximately 2 weeks. The patient's mother also reported that the patient was now experiencing pain at the generator site. When the patient saw another doctor for follow-up, he did believe that the patient's vomiting, nausea, pain at chest, under arms, hypotension and hiccups were related to the vns stimulation. He indicated that the patient's output current was too high at 2. 75 ma, so he decreased it to 2. 5 ma due to the vomiting and hiccups. No device error was noted by the physician. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8036490
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #693 on: December 10, 2018, 03:26:32 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury   
Event Description
It was reported that the patient was referred for vns explantation surgery due to irritation along the chest and left axilla, which the patient attributed to the vns. The vns was previously disabled for reasons unrelated to the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8091038
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #694 on: December 21, 2018, 10:04:39 AM »

Model Number 304-20
Event Date 07/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, an image of a patient¿s neck/chest area was provided where it appeared that the generator was sideways and protruding. Follow-up showed that the patient was implanted on (b)(6) 2013. The patient was seen on (b)(6) 2013 and reported that the device had been the way it was for a couple of weeks. Thee surgeon manipulated the device with some improvement of the protrusion. The patient was advised to continue to observe, but no intervention was recommended. There was no reported patient manipulation, trauma, or physiological changes that may have caused/contributed to the event. Follow-up with the surgeon showed that there was slight protrusion/flipping of the patient¿s generator. Clinic notes dated (b)(6) 2103 indicated that the patient had pain at the generator site when lying prone and on her side. The generator was mildly painful to palpitation. The device appeared rotated within the surgical pocket and was protruding beneath the skin. The device had not been programmed on. Clinic noted dated (b)(6) 2013 indicated that the patient returned for titration. The patient had continued pain at the generator site when lying prone or on her side. The device was interrogated: 0. 50/30/500/30/5/0. 75/60/500. The patient¿s pain would continue to be observed. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have discomfort intermittently with stimulation, particularly when lying down at night. A system diagnostic was performed with results of 3282 ohms. The patient was unable to tolerate an increase in output current, so stimulation was returned to the previous settings. Device settings were provided: 0. 50/30/500/30/5/0. 75/60/500. A revision referral indicated that the patient was to be revised due to discomfort and slightly elevated lead impedance. Follow-up showed that the referral was for patient comfort. On (b)(6) 2013, the patient underwent lead revision. At the time of surgery, fluid was seen in the outer tubing. The generator was briefly soaking in betadine. It was also noted that the lead was placed on the wrong nerve (anysa) by the previous surgeon. The new surgeon fixed the issue and notified the neurologist. The implant card indicated that the replacement was due to an "adverse event" and "malfunction". No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444285
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #695 on: December 24, 2018, 08:53:18 AM »

Model Number 302-20
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient was experiencing chest pain associated with magnet stimulation. It was reported that the physician did not program the device off after observing the high impedance because the patient has good seizure control and the patient's mother did not want the device disabled. The magnet output current was reduced and the magnet mode stimulation did not cause the patient pain. X-rays were ordered and a lead revision was discussed. It was reported that the patient's family did not recall a fall, accident or manipulation that could have caused or contributed to the high impedance. It as later reported that x-rays were performed and surgery was scheduled. It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. It was noted that pre-operative diagnostics resulted in high impedance (>=10,000 ohms) and that device diagnostics with the new lead and existing generator were within normal limits (1259 ohms). The lead has not been received for analysis to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement; however, only a small portion of the generator is visible. The filter feed-through wires and the lead pin cannot be assessed with the images provided. 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 remains unknown.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed 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=3523405
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #696 on: January 03, 2019, 09:07:13 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. During the surgery, the surgeon saw fluid in the lead so completed a lead revision during the prophylactic generator replacement surgery. Attempts for product return have been unsuccessful to date. The products have not been received by the manufacturer. Previously, it was reported in (b)(6) 2013 that the patient was experiencing painful stimulation in the chest and neck areas. The painful stimulation resolved when the vns was disabled with the vns magnet. X-rays dated (b)(6) 2013 were later received and reviewed by the manufacturer. There was no evidence of lead twisting, or sharp angles suggestive of a lead break. It is noted the lead appears to be ¿stretched¿ across the chest, as if it may be pulled if the head was turned to the right. No obvious lead anomalies were seen. There was no known trauma or manipulation. The painful stimulation was reported to be positional and was thought to have resolved prior to referral for surgery, and the cause of the painful stimulation was unclear to the physician.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of the lead device history records confirmed all quality tests were passed 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=363940
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #697 on: January 04, 2019, 11:43:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2018
Event Type  Injury   
Event Description
It was reported by a patient that they were experiencing chest pain upon swiping her magnet. She stated that this improved a little when her arm is moved back, but that it would take her breath away. It was stated that her neurologist explained it to be "high voltage", likely referring to high output current. Pulse width had previously been altered for tolerability. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141355
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #698 on: January 04, 2019, 11:45:28 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #699 on: January 04, 2019, 11:46:20 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8127177
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #700 on: January 05, 2019, 04:00:55 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via clinic notes received that the patient was referred for vns explantation surgery due to chest and jaw pain and the desire for mris. It was stated that the patient was seizure free for a year even with the vns disabled. Follow up revealed that the reason the vns was disabled was due to chest cramps experienced by the patient. The surgery to explant the vns was reported as both for the patient's comfort and to preclude serious injury as the patient had experienced pain and no longer used the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8163186
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #701 on: January 05, 2019, 04:01:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital for right sided weakness and chest pain and the patient reported that he had had chronic problems with the vns. The patient also reported focal seizures, the last of which was in (b)(6) 2018. Upon follow-up with the patient, it was reported that the patient was experiencing shortness of breath, chest pain, and pain in his throat which had reportedly been occurring on and off for the past few weeks. The on-call physician did not seem to think these symptoms were related to the vns. System diagnostics and normal mode diagnostics were ok. The patient's vns output frequency was lowered from 30 to 20 hz at the direction of the neurologist, who thought this would alleviate some of the symptoms. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8153856
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #702 on: January 10, 2019, 02:16:42 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3666903
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #703 on: January 14, 2019, 04:43:26 AM »

Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #704 on: January 14, 2019, 04:44:14 AM »

Model Number 300-20
Event Date 03/01/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012, that a vns patient thought his device was malfunctioning as it was sending electrical impulses to other parts of his body. The patient elaborated by saying he has been experiencing abdominal cramping, chest pain and should pain that was occurring every 5 minutes so he believed it as occurring with stimulation. The patient was also experiencing a shocking pain down his left arm and abdomen. When the patient met with his physician, he described the issues as a sharp pain in the left neck area, and sometimes it affects the left upper extremity, causing it to twitch, almost like a shock. At other times the pain is a funny sensation also in the right upper abdomen going to the right side of the abdomen. This lasts for about 30 seconds and occur every 3-5 days. Overall the pain is not and symptoms are not as severe, but they are still recurring, and strangely they do not occur every rhythmic beat with different time periods in between. The patient has not had any new weakness or numbness. No bowel or bladder changes. No trauma that could explain the symptoms. The patient does not have much of neck pain follow up with the physician revealed that the pain as subsided and the vns settings were lowered. The physician stated that the chest pain, should pain, and abdominal cramping were all related to vns however he did not indicate the relationship. There was no trauma or manipulation prior to the onset of any of the events nor was there any causal or contributory programming or medication changes. The physician will be programming the device off as a result of the reported events. The patient does not have a medical history of chest pain, shoulder pain, or abdominal cramping. When asked if there were any suspected device issues the physician responded "lead break?" however there were no diagnostic results available that indicated a device issue. X-rays were taken and sent to the manufacturer for review however no cause for the patient's adverse events was found. Additionally, no lead break or sharp angles were observed. The patient is going to be referred for revision surgery.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient denies having any pain with the device programmed off and there has not been any seizure activity either. The patient feels that the medications he is taking are controlling the seizures and he did not want to have his vns replaced at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2565708
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #705 on: February 09, 2019, 04:04:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient believed she experienced issues with her vagus nerve that caused stomach pain, pain in her neck that radiates down to the chest, migraines, and black out spells. The company representative indicated that the patient's generator system diagnostics were within normal limits. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8224067
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #706 on: February 09, 2019, 04:06:12 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/29/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported in clinic notes that the patient¿s lead was exposed and the patient had pain at the vns area. The lead had been exposed through the skin near the left armpit for the last four weeks. During surgery, a knot was found in the lead, surrounded by scar tissue. The surgeon was unable to remove enough scar tissue to detangle the knot, and chose to create a strain relief loop in the chest to prevent pulling on the knot. This knot was believed to be due to patient manipulation. The patient¿s generator was replaced. The device diagnostics on the new generator were within normal limits. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8262818
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #707 on: February 11, 2019, 02:45:27 AM »

Model Number 103
Event Date 02/01/2010
Event Type  Injury   
Event Description
Reporter indicated that she was experiencing shortness of breath and chest pain, for which she went to the er. At the er it was found that she also had an elevated heart rate and decreased oxygen saturations. A number of tests were run which all confirmed that the issue was not likely heart or pulmonary related. Information was later received that the pt's neurologist decreased the pt's programmed output current which has resolved the issues, as per the pt.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1641399
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #708 on: February 14, 2019, 02:34:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2016
Event Type  Injury   
Event Description
Information was received from the physician regarding the reported events. The patient¿s seizures did not worsen on vns, but instead the patient was a nonresponder to treatment. The patient reported pain in their chest at their last appointment, however the device was not disabled as the magnet mode has remained on. Surgery is likely but has not occurred to date. No additional information has been received.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: the type of report field was inadvertently not marked as ¿follow-up#¿1 on follow-up report#1. Corrected data: the date reported to manufacturer was inadvertently provided as 11/10/2017 on follow-up report #1 when it was intended to be provided as 12/05/2017.
 
Event Description
It was reported that a physician disabled a patient's generator because the patient was experiencing "too much chest wall pain with radiation into her left arm. " the physician programmed the normal output current off, but left the magnet output programmed on. No additional intervention has been taken for the patient's pain. The painful stimulation started about a month prior to the report. Diagnostics were within normal limits at the patient's last two office visits. The patient's settings were adjusted at the last office visit, so the diagnostics were performed after the painful stimulation began. Later follow-up was received (b)(6) 2017 from the surgeon's office that the patient was referred by the neurologist for explant of the device as the patient seemed unwilling to accept the side effects. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
The incorrect patient code was inadvertently provided on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6996132
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #709 on: February 16, 2019, 03:25:12 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
Follow up with the surgeon's office revealed that the surgical intervention was for the patient's comfort.
 
Event Description
The explanted generator and lead were received by the manufacturer. Analysis on the lead was approved. Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary 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 portions. Analysis on the generator has not been approved to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain. The diagnostics were found to be within normal limits. It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns. The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient. The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns. The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children. The patient underwent vns explantation surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
Generator product analysis was completed. The reported pain, painful stimulation, and dyspnea could not be evaluated in the product analysis, or pa, lab. However, proper functionality of the generator was verified in the pa lab. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids, which addresses the allegations of pain and painful stimulation. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No signs of variation in the signal were observed and diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance of other adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544133
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #710 on: February 17, 2019, 06:32:56 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #711 on: February 18, 2019, 01:33:02 AM »

Model Number 102
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient went to the er due to choking, shortness of breath, chest pain and an accelerated heart rate. The er physician placed the magnet over the device and the events resolved. Patient visited his treating physician after that and his device was disabled and patient was referred for removal surgery. Physician stated that the patient had no history of heart problems. Physician stated that the patient was set at 01/30/1000/60/180. Additional information received stated that the patient underwent a vns explant surgery. Explanted products were returned to manufacturer for analysis. Analysis is currently in progress for the explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888980
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #712 on: February 19, 2019, 04:00:20 AM »

Model Number 102
Event Date 06/16/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's cardiologist reported that the patient has a history of mitral valve regurgitation with replacement and cardiomyopathy. There were no medication changes or other factors that could have caused or contributed to the arrhythmia. The patient also has a history of first degree av block and sinus bradycardia. The patient the patient experienced atrial flutter with a heart rate of 122 bpm. The patient experienced dyspnea and palpitations during the atrial flutter. The patient underwent tfe with cardioversion. The atrial flutter did not recur. The patient's neurologist indicated that there is no relationship between the atrial flutter and vns.
 
Event Description
It was reported that the patient was hospitalized for five days on (b)(6) 2014 for rapid ventricular rate, atrial fibrillation and flutter. On (b)(6) 2014 the patient was admitted to the hospital for chest pain. The patient underwent transesophageal echocardiogram on (b)(6) 2014 and no clots were observed. The patient received cardioversion on (b)(6) 2014 and the heart rate returned to normal. The patient indicated that his inr was high and he had undergone pulmonary and gi testing. The patient's inr dropped below 2 and the patient underwent cardiac catheterization. The patient was released from the hospital on (b)(6) 2014. The relationship of the cardiac events to vns are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166277
« Last Edit: February 19, 2019, 04:47:42 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #713 on: February 22, 2019, 08:35:26 AM »

Model Number 302-20
Event Date 03/12/2015
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Adverse event or product problem; corrected data: the previously submitted mdr inadvertently provided incomplete information, as it did not specify that the event was both an adverse event and product problem. Outcomes attributed to adverse event; corrected data: the previously submitted mdr inadvertently provided incomplete information.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient reported pain in the chest area during device stimulation. The device was programmed off after observing the high impedance. The patient was referred for x-rays. The patient has been referred for surgery. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
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 patient underwent lead and generator replacement on (b)(6) 2015. It was reported that a keloid had developed around the explanted lead. The generator was replaced prophylactically. It was reported that the explanted lead was discarded. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664846
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #714 on: February 28, 2019, 03:43:36 AM »

Model Number 302-20
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2015, patient's vns device was disabled due to painful stimulation and lack of efficacy. Patient experienced headache, pain in the chest, neck and radiating pain in the left ear with stimulation. Systems diagnostics were performed and high impedance was observed. On (b)(6) 2015, the patient came back and wanted the device turned on. The patient had reported initially that she did not receive much benefit from vns. Once the device was disabled, the patient returned and said that she did receive benefit from it and therefore the vns was turned back on. Patient was referred for x-rays but it is unknown of the device was turned on again. Patient had previously reported headaches, painful stimulation in the neck and face and pulsating at the generator site since (b)(6) 2014. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. 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=4957000
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #715 on: March 02, 2019, 04:39:10 AM »

Device Problem High impedance
Event Date 06/26/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient reported having painful stimulation in the neck after walking in front of an mri suite with the door to the magnet open. Thus, the manufacturer's sales representative interrogated the patient's device and completed a diagnostic test which revealed high impedance on the patient's vns system. Two more diagnostic tests revealed normal impedance following the initial high impedance result. The patient's device settings were subsequently lowered but the patient continued to experience the painful stimulation, this time in the chest pocket. Thus, the patient's device was programmed off. The pain in the patient's neck returned following the device being programmed back on (b)(6) 2015, characterized as a pulling sensation in the left neck and ear. Thus, the device was again turned off, with only magnet mode current remaining on. Device diagnostics were run again which revealed normal impedance. X-rays were reviewed by the neurologist which showed the vns leads were intact. There has been no reported trauma or manipulation. The physician does not know how this high impedance event began occurring. No known surgical interventions have been performed to date.
 
Event Description
Additional programming history was received and reviewed. The data obtained shows programming events from the date of the event, (b)(6) 2015, as well as a follow up visit with the treating physician on (b)(6) 2015. On (b)(6) 2015, the patient came in with the device disabled and left with device disabled as well. System diagnostic performed on (b)(6) 2015 resulted in normal impedance. The internal data decoded from the vns generator was reviewed as well. The data shows that impedance changed from 2356 ohms to 21822 ohms on (b)(6) 2015 from a 24-hour impedance measurement. System diagnostics performed later on (b)(6) 2015 showed an impedance change from 21822 ohms to 2089 ohms. Thus, the high impedance appears to have appeared and resolved all on (b)(6) 2015. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4936447
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #716 on: March 03, 2019, 11:23:46 AM »

Model Number 100
Event Date 12/27/1997
Event Type  Injury   
Event Description
During the investigation of a vns patient's reported event, it was noted that the patient had her leads removed in 1997. There was no reported reason for this removal at this time of the discovery. Follow-up revealed that the patient had been a part of an epilepsy study, which she exited in 1996. However, information from the patient's last known following physician indicated that the patient had in fact undergone a full explant in 1997 due to "chest pain and difficulty breathing. " no more information on the issues could be given by the site. A search of the manufacturer's programming history database showed last known diagnostics were performed on (b)(6) 1997. Results were within normal limits at this time. Furthermore, last known settings on this date show the device's being disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069297
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #717 on: March 07, 2019, 02:33:00 AM »

Model Number 302-30
Device Problem Positioning Problem
Event Date 09/03/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient was hyper-sensitive to the pain, so initially it was believed that there was nothing wrong other than the presence of the device causing pain. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 due to the chest pain as well as painful stimulation. Pre-operative diagnostics revealed normal impedance of 1,590 ohms. During the replacement surgery, the surgeon observed a crack in the lead insulation with some fluid inside. There was no known trauma which caused this. The lead was not revised.
 
Event Description
It was reported that the patient was having pain at her vns generator implant site and thus was wanting the device repositioned. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5106217
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #718 on: March 07, 2019, 02:34:06 AM »

Model Number 103
Device Problem Material Protrusion / Extrusion
Event Date 05/13/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received that the patient was referred for a generator repositioning surgery due to generator discomfort. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a vns pocket revision surgery on (b)(6) 2015 due to the discomfort he was experiencing. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was complaining of pain around the vns generator. It was also reported that the generator is protruding more from the chest than it has in the past. These events reportedly began occurring following a recent vns generator implant on (b)(6) 2015. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4962338
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #719 on: March 07, 2019, 02:34:53 AM »

Model Number 300-20
Event Date 07/15/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.
 
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=4959601
Logged
Pages: 1 ... 22 23 [24] 25   Go Up
Print
Jump to: