Pages: [1]   Go Down
Print
Author Topic: Sodium Levels  (Read 715 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« on: October 26, 2018, 01:05:37 AM »

Model Number 101
Event Date 01/01/2007
Event Type  Injury  
Event Description
It was reported that the patient was scheduled for vns explant due to an unknown reason. Upon further follow-up, the nurse at the treating physician's office reported on (b)(6) 2012 that the patient's device is being scheduled for explant because it was turned off some time ago for an unclear reason. She thought it may have been due to a low heart rate. Follow-up with the nurse revealed the patient had generator replacement on (b)(6) 2001, and on (b)(6) 2001, the patient was admitted to the hospital with low sodium of 120 on carbamazepine and levetiracetam. She was taken off carbamazepine, and was readmitted on (b)(6) 2001, with cognitive abnormalities on levetiracetam and phenytoin. She has a history of episodic tachycardia and is on betablocker since 2007. Patient was started on ltg in 2008, and the vns was turned off on (b)(6) 2008, due to tachycardia without underlying cause. Per the nurse, after having her device turned off for several years, the "episodic tachycardia remains unexplained, but she is taking a beta blocker". A note from the cardiologist dated (b)(6) 2008, stated that the patient's seizure medications were reduced and she had one significant seizure episode. Since then, she had more palpitations and some vague chest pain. Patient returned on this day for a follow-up due to recent increase frequency of palpitations. Patient had episodes of seizures about every two to three weeks, and it was noted that the patient had a vagal nerve stimulator placed. After the seizure episodes, the patient had palpitations usually at night and lasted for less than minutes, most consistent with probable premature beat feelings. The metoprolol sode was increased to "25 mg daily for pac or inappropriate sinus tachycardia suppression. She also had some vague chest pain and was initiated for cad evaluations. She also has some exertional fatigue. Otherwise, she denied any other cardiac-related complaints". Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the supplemental report #1 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2012.
 
Event Description
Additional follow up with the nurse was performed who reported that the details regarding the events are not remembered. The patient was complaining and being treated for tachycardia. The vns was turned off for an mri on (b)(6) 2008, and the patient had it turned back on (b)(6) 2008 reportedly. When trying to turn the output current on, the nurse reportedly "could not get the output past 0. 75ma" due to extreme coughing. Although the previous output current was 2. 0ma, the site attempted to turn the current to 1. 75ma but the patient experienced violent coughing. Current decreased to 1. 5ma with on time every 3 minutes and off time at 1. 8 minutes. The settings were not tolerated, and continued to not be tolerated at 1. 25ma. Current was therefore decreased. Due to the tachycardia, the vns was turned off soon after per the nurse (which was observed on (b)(6) 2008). Later on (b)(6) 2009, the notes indicated that the device had been turned off with no exacerbation of seizures over 6 months. Patient requested to have the device removed for reasons of pain and discomfort at night. Patient was referred for surgical consult for vns explant. Notes dated (b)(6) 2009 revealed that the patient requested to have vns removed, "as it has not been helping and is somewhat uncomfortable moving around in the pocket".
 
Event Description
Follow-up with the implanting surgeon revealed that from the generator replacement in 2008 there was no mention of a suture being used in the operative note of use of suture to secure the generator to the fascia. Training was provided to the surgeon's office regarding labeling recommendations that a non-absorbable suture be used to secure the generator to prevent such occurrences of generator migration.
 
Manufacturer Narrative

Manufacturer Narrative
Suspect medical device, lot number, expiration date, corrected data: the initial report did not report this product information at that time. Device manufacture date, corrected data: the initial report did not report the manufacturer date at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883274
« Last Edit: February 14, 2019, 11:48:19 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #1 on: October 26, 2018, 01:06:44 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/14/2017
Event Type  Death   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as metabolic encephalopathy is not expected to be related to the vns.
 
Event Description
The patient's last hospital discharge report was received and indicated that the patient was discharged into home hospice care three days prior to death. The patient was reportedly admitted to the hospital for metabolic encephalopathy and worsening dementia. However, the patient had other active problems reportedly, as follows: generalized convulsive epilepsy, hypothyroidism, acute kidney failure, hypernatremia, hypokalemia, osteomyelitis of jaw, weakness, debility. The hospital encounter was reportedly included consultation with palliative care. The patient was discharged in poor condition with none of his problems resolved. No further relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
A company representative saw through a newspaper obituary that this patient passed away in his home due to an unspecified reason. The patient's neurologist did not know the patient's cause of death as they also found out through the newspaper. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6335581
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #2 on: February 15, 2019, 03:34:39 AM »

Model Number 102
Event Date 06/30/2013
Event Type  Death   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Follow-up with the funeral home showed that the patient was buried with the device.
 
Event Description
Additional information was received that indicated that the death was due to sepsis and respiratory failure. The death was not related to sudep or vns. The patient had 2 seizures on (b)(6) 2013 and was given diastat. The patient then had 3 more seizures and was sent to the emergency room and was admitted. The patient was diagnosed with recurrent seizures, a urinary tract infection, hyponatremia, hypothyroidism, hypotension and developed renal failure.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient died on (b)(6) 2013 due to multiple seizures. The patient was scheduled for a battery replacement in (b)(6) 2013 due to their device being at end of service. This death event has been reviewed and with the available information has been determined not to be sudep. With the available information, the death was due to multiple seizures. Good faith attempts are currently being performed for additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3253134
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #3 on: February 15, 2019, 03:35:17 AM »

Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient had a right frontal subcortical ischemic stroke that lead to bilateral hematomas, unknown relationship to vns. The patient was also experiencing an increase in seizures, unknown cause or relationship to vns. It is unknown if the increase in seizures is above or below baseline. The patient had a cluster of three seizures on (b)(6) 2011 and it was taken to the emergency room. Blood work showed mild hyponatremia. The patient had a prophylactic generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2196462
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #4 on: February 15, 2019, 03:36:06 AM »

Model Number 300-20
Event Date 08/20/2012
Event Type  Malfunction   
Event Description
The patient had full revision surgery on (b)(6) 2012. However, the explanted generator and lead were discarded after surgery by the hospital, so product analysis cannot be completed. Additional review of the clinic notes revealed that the patient's generator was turned off on (b)(6) 2012 due to the high impedance. The patient was instructed to continue with the current dose of aeds.
 
Event Description
Clinic notes dated (b)(6) 2012, revealed that normal mode diagnostics resulted in high lead impedance. The patient has a history of intractable seizures status post vns placement. The notes do not reveal that the patient experienced any clinical symptoms. The patient was hospitalized on (b)(6) 2012, due to seizures caused by hyponatremia, so the patient's medications were changed. Since being discharged, the patient had been doing well without recurrence of any seizure or seizure like activity. The patient's wife noticed that he appeared to be more alert and awake since stopping trileptal. The notes indicated that the patient tolerated these medication changes and current setting of vns well without any side effects. Attempts for additional information have been unsuccessful to date. A/p and lateral images of the neck and a/p images of the chest were reviewed by the manufacturer. The generator was able to be visualized in the left chest. The lead pins were seen past the second connector blocks, and the lead wire was intact at the location of the connector pins. The filter feed-through wires are intact. A portion of the lead is behind the generator and continuity in that portion of the lead could not be assessed. The electrode placement appeared to be normal. There appears to be a lead discontinuity in the portion of the lead body after the strain relief loop where the lead transitions from the neck to the chest. However, no other discontinuities were visualized. Based on the x-ray images provided, the cause of the reported high impedance appears to be a lead discontinuity. However, the portion of the lead located behind the generator could not be assessed and the presence of a micro-fracture cannot be ruled out.
 
Manufacturer Narrative
Corrected data: the initial report inadvertently did not report that the device was disabled and the additional information indicated on the clinic notes.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity in the lead wire following the strain relief after the electrodes. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2759188
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #5 on: February 15, 2019, 03:37:00 AM »

Model Number 102R
Event Date 07/30/2007
Event Type  Injury   
Event Description
On (b)(6), 2011, a vns treating physician reported that the vns patient was being scheduled for battery replacement for prophylactic reasons but that the patient was experiencing an increase in seizures, pre-vns baseline unknown. Since then, however, the generator has reached end of service. On (b)(6), 2011, the vns patient went for battery replacement. The explanted generator was returned for product analysis that has not yet been completed. Clinic notes from the physician were received through case management. Review of the clinic notes dated (b)(6), 2011 revealed that the patient was having 1 seizure every 2-3 weeks and that her last seizure was 2 weeks ago. The patient was status post an excision of acoustic neuroma and her seizures began after this surgery. The patient has a history of acoustic neuroma resection since 1980, a pre-vns condition. The patient's history also lists a stroke; it is unclear at this time its relationship to vns. Clinic notes dated (b)(6), 2011 report that the patient continues to have seizures at roughly the same frequency despite the introduction of vimpat. The patient felt that something was different or not quite right so her vns was checked and it was discovered that the vns was at eri = yes. The patient was then referred for battery replacement. Clinic notes dated (b)(6), 2010 state that the patient had more seizures; over the past two months she has had about 4 to 5 complex partial seizures with the most recent occurring the day before. Otherwise, the patient has been relatively free of seizures for the past few months compared to her typical frequency before this. It was discussed the possibility of increasing vimpat and decreasing carbatrol to see if that would help control her seizures better. Clinic notes dated (b)(6), 2007 reported that the patient had a slight increase in the frequency and duration of seizures with the most recent increase in her vns output to 3. 00ma. Previously she had seizures every 3 weeks, but after the change, she began to have seizures every two weeks. The patient asked to have the device returned to the previous setting of 2. 75ma output. A battery life calculation was performed which showed negative years until eri = yes. When additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted generator. The reported end of service allegation was duplicated in the product analysis laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. The case manager reported that the patient's baseline prior to vns was 3-7 seizures a month but the patient varies widely. Therefore, the patient's increases in seizures are below or at the same level as pre-vns baseline frequency. The case manager also said that the patient's sodium levels are not under control due to the antiepileptic drugs and this combined with stress make the patient have more seizures. She said the patient's recent increase in seizures and the change in seizure pattern is due to the vns being at end of service. There was a medication change on (b)(6) 2010 where the physician started her on vimpat. On (b)(6) 2010 the physician reported that he had asked her to decrease her carbatrol dose by 300mg while she increases vimpat to 150mg twice daily. The case manager reported that this medication change is likely what caused the patient's increase in seizures around that time period. The case manager then provided additional clinic notes from (b)(6) 2006 which showed that the patient had 10 small seizures and one event that was bigger than her usual small episodes in early (b)(6). The physician reported that this occurred when she was under a significant amount of stress however and has been her typical pattern over the past few years. He reports that he can't seemingly get any better seizure control for the patient despite changes in medication and the vns parameters. The physician reported that the patient's stroke that was listed in the clinic notes dated (b)(6) 2011 is a mistake. There was no stroke at all; the patient just had a cranial nerve injury stemming from a brain surgery performed many years ago. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2172590
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #6 on: February 15, 2019, 03:38:07 AM »

Model Number 302-20
Event Date 09/27/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012 it was reported that the patient was seen the day prior as the patient was not feeling magnet stimulation and had noticed this on (b)(6) 2012 when she tried to swipe the magnet. When diagnostics were performed on (b)(6) 2012, high impedance was observed. The physician stated that he was not aware of any patient manipulation or trauma that had recently occurred. X-rays were taken and ap and lateral views of the neck and chest for the patient were provided to the manufacturer. The images were dated (b)(6) 2012, (b)(6) 2011, (b)(6) 2001, and (b)(6) 2009. The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. No break was observed in the lead body; however, there is a questionable spot that was unable to be fully visualized due to the patient's ribs on the x-ray dated (b)(6) 2012. This was not seen on the previous x-rays. Based on the x-ray images provided, the cause of the high impedance cannot be determined as no discontinuity was identified. The questionable spot at the patient's ribs was not seen on the x-rays taken prior to the high lead impedance reading so this area cannot be ruled out. The presence of additional micro-fractures in the lead can also not be ruled out. A battery life calculation was performed on (b)(6) 2012 which showed 4. 55 years remaining until neos =yes. Clinic notes were also received dated (b)(6) 2012 that stated the patient was recently admitted to the emergency room with some nausea and vomiting. The patient was noted to have been tolerating the stimulator and doing well. The patient's vns was checked and the settings were the same as the previous visit and the battery indicated normal life. The patient¿s mother thought it was due to low sodium but her sodium was 133, which the physician thought was only minimally abnormal, not enough to cause symptoms. Clinic notes dated (b)(6) 2012 were also received which indicate that the patient has not felt magnet stimulation. It was reported that the magnet had been used three times but the patient had not felt these; the physician confirmed that there were three magnet swipes recorded for the device. The patient's device was disabled due to the high impedance and the patient¿s mother voiced concern that the device is turned off as the patient has aggressive seizures that hospitalize the patient and she goes into status. The patient underwent a full revision surgery on (b)(6)2012. Pre-operative interrogation confirmed the output and magnet currents were both set to 0. 0 ma. Pre-operative system diagnostics indicated dcdc=7/output=limit/lead impedance=high/eri=no. The surgeon first explanted the generator and stated there were no obvious discontinuities or anomalies with the visible portion of the lead. He then connected the new generator to the existing lead and preformed a system diagnostic test that resulted in high impedance (10,000 ohms). At this point the surgeon disconnected the new generator and continued to explant the old lead. The new lead was then implanted and connected to the new generator. Proper pin insertion was verified and a single click of the screwdriver was heard when tightening the set screw. Three system diagnostic tests (one out-of-pocket and two in-pocket) indicated output=ok/lead impedance=ok/impedance value=1605/eri=no, output=ok/lead impedance=ok/impedance value=1312/eri=no, and output=ok/lead impedance=ok/impedance value=1324/eri=no. Attempts for the return of the explanted products are underway but they have not been returned to the manufacturer to date. The patient's physician reported that he was unaware that the patient had experienced nausea or vomiting and was not able to provide any further information.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(4) 2013 when a review of the manufacturing records confirmed all manufacturing and qc inspection steps were signed off prior to distribution.
 
Event Description
Additional information was received on (b)(6), 2012 when it was reported that after surgery, the lead impedance was noted to be "ok". The explanted lead and generator were returned to the manufacturer on (b)(6), 2012 for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Product analysis on the lead was completed on (b)(4) 2013. The (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the partial detachment and bubble observed in the connector ring / connector boot area and insufficient adhesive observed inside the anchor tether silicone tube. 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, with no discontinuities identified. What appeared to be remnants of dried body fluids were observed inside the outer and inner silicone tubes in some areas. Product analysis observed a small area of tubing delamination near connector ring area and also insufficient adhesive backfill in anchor tether area; however, it appears to have no adverse effect on product functionality.
 
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.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed device met specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2863472
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #7 on: February 15, 2019, 03:39:09 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 04/09/2014
Event Type  Death   
Event Description
It was reported by the physician that the patient had deceased. An obituary was found which found the patient had passed away on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
It was found that in the state of (b)(6), vital records are not open to the general public and can only be obtained by the individual, guardian, or other legal party and the death certificate will not be able to be obtained from the state of missouri by the manufacturer.
 
Manufacturer Narrative

Manufacturer Narrative
Outcomes attributed to adverse event: death. Initial mdr inadvertently omitted outcome attributed to the adverse event and date of death. Type of reportable event: death. Initial mdr inadvertently marked the type of reportable event as serious injury instead of death.
 
Event Description
It was reported by the funeral home the patient had a graveside burial. It was noted the patient probably did not have the vns device explanted as it was just a burial. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported through hospital notes received by the manufacturer that the contributing factors to the patient's death were aspiration, refractory seizures, and history of renal cell cancer. The contributing factors for the patient's admission to the hospital were thrombocytopenia, seizure disorder, and hypernatremia. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5193626
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #8 on: February 15, 2019, 03:40:01 AM »

Model Number 104
Device Problem Insufficient Information
Event Date 10/04/2015
Event Type  Death   
Manufacturer Narrative

Event Description
Records received from the hospital that the patient passed away in indicate that the patient was admitted on (b)(6) 2015 and was found to be in acute renal failure. The patient was started on iv fluids. During the hospital stay, the patient's condition kept deteriorating. Palliative care consultation was done. The patient was scheduled to be discharged to a skilled facility with possible hospice, but the patient expired on (b)(6) 2015. The patient had a durable do not resuscitate request. The cause of death was noted to be chronic obstructive pulmonary disease, end-stage. Other diagnoses were listed as acute renal failure, hypernatremia, hypomagnesemia, malnutrition (severe), weakness, history of seizures, dysphagia.
 
Event Description
It was reported that the vns patient passed away. The physician's office was unaware of the cause of death. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the cause of death was myelopathy with quadriplegia, acute renal failure, advanced copd and refractory seizures. The physician indicated that the cause of death was not related to vns therapy. There was no autopsy performed and the death was witnessed by the hospital nurse. There was no history or drug or alcohol abuse and the patient was compliant with aeds. The physician indicated that the patient experienced a reduction in seizures with vns therapy and was receiving therapy at the time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5402604
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #9 on: February 15, 2019, 03:41:30 AM »

Model Number 102R
Event Date 05/01/2008
Event Type  Injury   
Event Description
Clinic notes were received reporting that a vns patient was seen in clinic on (b)(6) 2008 and he was having seizures about once a month, and his wife thinks they are more violent. The patient's vagus nerve stimulator interrogates fine. In the past he has been on a higher dose of keppra. Reported that they did not have room to increase the vagus nerve stimulator further, so i will go ahead with a higher keppra dose. Good faith attempts are underway to determine if the patient had a change in seizure type. Thus far no further information has been received.
 
Event Description
Additional information was received. The patient's wife reported that she is not sure if generator is working or not. She thinks it is working but the patient has had an increase in seizures since the beginning of the year which is unusual. The patient is going to be scheduled for generator replacement. The patient's sodium level was low and they cannot do surgery at this time. The patient was admitted to hospital to have a sodium drip. At this time no surgery is planned.
 
Event Description
A fax was received from the patient's treating physician reporting that the patient had not been seen since (b)(6) 2011. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435271
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #10 on: February 15, 2019, 03:42:24 AM »

Model Number 103
Event Date 02/25/2015
Event Type  Death   
Manufacturer Narrative

Event Description
Initially, it was reported that the patient was placed in hospice care after being seen in the hospital due to elevated sodium levels. It was reported that the patient's level was very high (over 800) and has caused severe damage to the kidneys. The patient has a history of elevated sodium levels for no reason. It was later reported that the patient passed away due to natural causes. The relationship of the death to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
An online obituary indicated that the patient passed away from kidney failure. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632621
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #11 on: March 06, 2019, 01:43:09 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 10/28/2014
Event Type  Injury   
Event Description
It was reported by a patient's mother that the patient was having an increase in seizures since his vns replacement surgery on (b)(6) 2014. The patient was hospitalized for a few days in (b)(6) of 2015 for multiple seizures, at which time they found the patient to have low sodium levels, which is a possible, but not confirmed, reason for the increase in seizures. The patient had a few more seizures after the hospitalization, mostly left focal and petite mals. The patient is usually seizure free during the summer months, but he has had seizures during the summer of 2015. The patient had more petite mals and myoclonic jerks that were stopped by swiping his magnet, and they come and go from month to month. The information received from the patient's mother has not been substantiated by the patient's physician(s). No other relevant information has been received to date.
 
Event Description
Neither of the patient's physicians believed that there was a clear relationship of the change in seizure pattern to vns. The physician's declined to answer any further questions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001048
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #12 on: March 09, 2019, 02:16:57 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an increase in seizures. Low sodium levels, and pneumonia. The pneumonia and low sodium levels were not alleged to be related to vns. Livanova operating room support specialist checked the patient¿s device, and it was found to be operating as expected. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8301454
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #13 on: April 16, 2019, 12:54:42 AM »

Model Number 106
Event Date 08/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had a seizure that was much stronger than normal. The patient went to the emergency room in relation to the strong seizure. The er staff indicated that the patient's sodium levels were low, which may have contributed to the seizure. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up communication with the treating physician's office confirmed they saw the patient since the reported seizure. No vns diagnostics or settings were apparent from the appointment notes, although the clinic notes from the visit did mention the patient's vns was checked. The physician's official ruling on the trigger for the patient's seizure was hyponatremia. There was no suspicion it was related to vns in some way, and no interventions had been taken. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965519
Logged
Pages: [1]   Go Up
Print
Jump to: