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dennis100
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« on: July 20, 2018, 12:52:59 AM »

Model Number 102
Event Date 03/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013, it was reported that this patient was implanted. The explanting facility discards explanted devices.

Event Description
Clinic notes were received for review on a vns patient. Clinic notes mentioned that the patient had been doing well but had 2 seizures in the past month and had a seizure that was more severe than her usual spells. Notes from a few months prior noted that the patient had not had any seizures, therefore and increase in seizures as well as change in seizure pattern will be reported. ((b)(6) 2013) clinic visit reports she has been having some problems. She had what sounds like a complex seizure - she felt "out of it" and confused and she fell down 6 concrete steps. She remembers the entire event. Her lower leg was cut and her entire right side bruised. She denies any visible head injuries or lacerations. She had a few dull headaches but those are gone now. She never completely lost consciousness. A few days later on (b)(6) she was in bed and "my husband couldn't wake me up". He tried to wake her for 10 minutes and she would not respond. She was not shaking or jerking. Then when she initially came around she did not feel normal. Since (b)(6) after that event she has felt dizzy and mixed up. She has not felt back to normal since then. She just feels a little confused. She is off balance. No more seizures since then. She feels like she had a seizure because has done this before but it is atypical for her normal pattern. She cannot keep up with her medicine now and her husband is making her pill box for her. The patient 's vns was easily palpated. Vns generator is 6 years old. Battery still functional - no changes made. Usually very well controlled, but 2 seizures in the last month. Her drug levels were reported to be okay. Noted the patient fell down 6 concrete steps - had a seizure a few days later that was more severe than her usual spells. Testing will be done to rule out ich/subdural hematoma or other structural lesion. Good faith attempts are underway for further details about the reported events.

Event Description
Additional information was received that the patient's change in seizure pattern started in (b)(6) and it was an increase in seizure frequency. The relationship to their vns therapy may be none but they were also due for a battery replacement. Diagnostic tests were ok, specifics not provided. The patient will have their generator replaced. They had surgery scheduled but it was postponed related to a cough. No date is set at this time. The patient's increase in seizures was increased complex partial seizures with secondary generalization.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074961
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dennis100
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« Reply #1 on: July 20, 2018, 12:54:16 AM »

Event Date 11/16/2009
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient¿s lead was not replaced during the procedure on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostic results showed lead impedance within normal limits (impedance value - 3459 ohms). The patient¿s replacement device was programmed back on previous device settings.
 
Event Description
Analysis of the generator was completed on 07/10/2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Clinic notes dated (b)(6) 2013 stated that this vns patient recently relapsed and began to have spells of confusion several times each day. The patient was seen on (b)(6) 2013. When the patient was seen on (b)(6) 2013, she had return to her baseline neurological status. Apart from the complex partial seizure with awareness and confusion impairments, there were no other positives in the patent¿s review of systems. The patient complained of pain at the generator site due to the sagging nature of the device related to the site of implant. The patient wanted breast augmentation and evaluation of the implant site. The device was interrogated, and the settings had been recently adjusted on (b)(6) 2013 to abort seizures. The patient was now doing well. The patient¿s condition was stable. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that device diagnostics were within normal limits. Clinic notes dated (b)(6) 2014 note that the patient has experienced issues with the position of the device over the last several months and now complained of pain related to stimulation of the device. At times the patient states the pain is not tolerable. The notes indicate that the patient's seizure frequency is much improved due to the device itself. The patient complains about pain in the neck at the site of the device. The patient also complains that pain in the left side of the chest is close to the device. It was noted that the generator seems to be hanging and it makes her more uncomfortable. The patient has tenderness at the site of the generator and also in the neck where the lead is placed. The notes indicate that the pain is intensified with magnet use. It was noted that the problem appears to be due to the suspension of the device. Device settings were adjusted and the patient was referred for an appointment with a neurosurgeon. The patient underwent generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
On (b)(6) 2014, it was reported that the patient was referred for breast implant surgery as she has no breast tissue to attach the device to. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3537553
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dennis100
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« Reply #2 on: July 20, 2018, 12:55:14 AM »

Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description
A vns flowsheet was received which noted on patient's visit on (b)(6) 2010 the patient decribes an increase in seizure frequency with right arm tremors and spells of confusion. It is unknown if the increase was above the patient's pre-vns baseline frequency. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Further follow-up revealed that the patient's increase in seizures was below the patient's pre-vns baseline frequency. The physician indicated that there was no relationship between the increase in seizures and vns therapy. The physician reported that the increase was a single episode where the patient lost consciousness in the shower and was not observed. The physician noted causal or contributory external factors that predeeded the onset of the increased seizures as the patient had stopped treatment with cpap for obstructive sleep apnea. The physician noted that the patient has a previous diagnosis of obstructive sleep apnea. The patient underwent uvulopalatopharyngoplasty in (b)(6) 2012 and that the obstructive sleep apnea was previously severe in 2009. The patient did not do a follow-up study after the surgery. Attempts to obtain additional information on the obstructive sleep apnea have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025597
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dennis100
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« Reply #3 on: July 20, 2018, 12:56:20 AM »

Model Number 103
Event Date 07/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had taped her magnet over her generator to disable her device due to voice alteration. When she removed the magnet, the patient began to feel confused and reportedly had a seizure. The patient stated that she was experiencing an increase in seizures when her device was programmed back on. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s response to the removal of the magnet was a vasovagal response. The patient experienced confusion and a seizure following the removal of the magnet. No changes to medication or device settings were made prior to the event, which was clarified to be not an increase in seizures. The patient's anxiety was reported to be related to vns stimulation. The patient experienced both anxiety and a vasovagal response previously with vns stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3958493
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dennis100
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« Reply #4 on: July 20, 2018, 12:57:08 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury   
Event Description
The vns patient recently had surgery to replace the vns device in (b)(6) 2010 (previously reported in manufacturer report # 1644487-2010-01171), and since surgery, the patient had been experiencing pain in the left neck and the face. The physician had lowered the device settings to help with the pain. Over the next week the pain had resolved and the patient was doing well. It was then reported that the patient began experiencing intermittent seizure activity and confusion on (b)(6) and went to the emergency room. The patient was transferred to a different hospital, and the physician had made minor adjustments to the vns settings, and she was observed for several days but became very ataxic. After the physician's reviewed, the patient's medication, it was noted that the patient had taken an older (expired) bottle of lyrica to the hospital and was receiving twice the prescribed amount. After realizing the issue with the medication, it was corrected and the ataxia resolved and the patient was discharged. The patient was then for a follow up appointment at (b)(6) and the patient was experiencing migraine headaches, which per the physician is usually a sign of latent seizure activity. The physician opted to increase the device settings. Several days later, the patient then experienced a fairly severe migraine with confusion for the majority of the day, which seemed to resolve with no interventions. The patient is being closely monitored by the physician. At the time the patient was experiencing the migraines and confusion, it was also noted that the patient has not had a bowel movement for approximately a week, and the patient's appetite was diminished. The physician additionally explained that the patient is under a great deal of stress in her life at the moment, which could also be a contributory factor. At this time, the physician's assessment regarding the relationship of the events to vns is unclear. Good faith attempts to obtain additional information from the treating physician are currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828271
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dennis100
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« Reply #5 on: July 20, 2018, 12:58:01 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
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dennis100
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« Reply #6 on: July 20, 2018, 12:58:46 AM »

Model Number 102R
Event Date 10/27/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient fell in the bathtub on (b)(6) 2014 and subsequently was unable to perceive magnet mode stimulation on-times. The patient began experiencing ataxia and staring spells associated with confusion. The patient fell seven more times following the initial fall in a span of two days so the patient went to the er on (b)(6) 2014 and was admitted to the hospital. Follow-up revealed that the patient was later stable. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277287
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dennis100
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« Reply #7 on: July 20, 2018, 12:59:45 AM »

Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. The clinic notes dated (b)(6) 2012 revealed that over the years the severity and frequency of the patient's seizures have gradually increased. The patient reports two different types of seizures; the first type he reports feeling confused and may lose balance and fall. These episodes are relatively short, lasting seconds to a few minutes. The second type of episodes represents secondary generalized convulsions, which also last only a few minutes. The patient continues to have approximately 1-3 seizure episodes per week. The clinic notes list the patient's medical history consisting of coronary artery disease, hyperlipidemia, and coronary atherosclerosis of native coronary artery. The patient experiences hiccups and voice alteration with vns stimulation. The patient was prescribed baclofen for his hiccups. The physician indicated that when the patient has his vns replaced, they may seek a lower target dose in the hopes of avoiding hiccups which the patient associates with his vns settings. A battery life calculation was performed which showed 5. 46 years remaining until eri=yes. Attempts for further information from the physician have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2657377
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dennis100
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« Reply #8 on: July 20, 2018, 01:00:34 AM »

Model Number 103
Event Date 06/27/2011
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011. The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types. The episodes involved the patient chewing his tongue and losing consciousness. The patient was sleepier and more confused during the post ictal period. Since hospitalization, the patient had 1-2 seizures. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942259
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dennis100
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« Reply #9 on: July 20, 2018, 01:01:36 AM »

Model Number 102
Device Problem No Information
Event Date 06/09/2015
Event Type  Injury   
Event Description
It was reported that the patient woke up with a lump around the generator and was experiencing painful stimulation. The device was programmed off and x-rays were ordered. It was later reported that the patient had a knot over the left neck area and will need to be seen by the surgeon. Clinic notes dated (b)(6) 2015 note that the patient started noticing a knot in the neck the day prior and that the generator was programmed off. It was also reported that the patient was experiencing confusion. No known surgical interventions have been performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the generator implant site was slightly raised. The confusion resolved when the generator was programmed off. There was no patient manipulation, programming or medication changes, or trauma that is believed to have caused the mass and the painful stimulation. X-rays were performed on (b)(6) 2015 which did not identify any adverse vns findings. It was reported that the patient has not yet been seen by the surgeon. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was seen by the surgeon who believed the device should be reactivated as there was nothing found wrong with the vns. The physician believes that the vns has been helpful for the patient; however, the surgeon is sending the patient for resective surgery consult. The patient reported that the device is fine, but is nearing end of service. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4893039
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dennis100
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« Reply #10 on: December 14, 2018, 07:25:57 AM »

Model Number 102R
Event Date 11/08/2010
Event Type  Injury   
Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
On (b)(6), 2012, a fax was received from the physician with information regarding the patient's change in seizure pattern from (b)(6), 2010. The physician stated that there was no relationship of the event to vns. The change in seizure pattern was not significant. The interventions taken included checking the patient's levels, educating the patient, and checking the vns. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the change in seizure pattern.

Event Description
Clinic notes dated (b)(6) 2010 were received on may 6, 2012 regarding this vns patient. The clinic notes allege that the patient's recent seizures have been different than those in the past. The patient reports doing things or having conversations after his seizures and then having no recollection of those events. Sometimes, he will wake up or become aware of his surroundings without knowing how he got there. The patient reports having pre-seizure activity one to two times per week. Occasionally, swiping his magnet will stop the seizure. The patient's last generalized tonic-clonic seizure was about one month ago ((b)(6) 2010). The patient's seizures are characterized as generalize tonic, clonic movements, deviation of eyes and head to one side and focal movements followed by generalized clonic movements. The seizures are preceded by an aura and followed by confusion and lethargy. The patient is having more difficulty remembering how he got to places, losing track of time, and his caretaker reports he just seems "out of it at times. " the patient has been incontinent at times but no tongue biting has been reported. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2595567
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dennis100
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« Reply #11 on: February 21, 2019, 02:03:32 PM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient may have a broken lead as the patient¿s generator battery indication changed from 50% to 10% in 4 months. The generator was noted to be at ifi ¿ yes and the patient has been having a lot of seizures. Further follow up indicated that the patient¿ device diagnostics showed high impedance. Clinic notes were later received indicating that the patient had significant worsening in seizure duration and frequency. Patient is having complex partial seizures at the rate of 2-3 per day. Recent symptoms that patient experienced include: intermittent confusion, inability to talk, funny feeling in head, staring, and reporting that she was hot, staring spells, pausing at in appropriate parts of a sentence. Patient¿s compliance with treatment was reported to be good. Patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were not returned to the manufacturer per the explant facility policy.
 
Manufacturer Narrative
Available programming and diagnostic history were reviewed. Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4697733
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