Pages: [1]   Go Down
Print
Author Topic: Endocrine  (Read 1442 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« on: May 16, 2018, 01:52:12 AM »

Model Number 106
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing an increase in seizure frequency and duration. The patient had two 4-minute seizures in one month and it was noted that the length of the seizure was unusual for the patient. The patient had also been experiencing hyperventilation and reported that his head was not feeling well. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s issues were not related to vns but to an endocrine problem that resulted in a loss of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309662
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #1 on: May 19, 2018, 02:40:36 AM »

Model Number 103
Event Date 11/14/2013
Event Type  Death   
Event Description
It was reported that it was believed that the death certificate listed gastrointestinal disease/ulcer as the cause of death, but that the copy was too hard to read. It was reported that no autopsy had been performed and there was no knowledge of device explant. The patient was cremated. The hospital discharge summary indicated that the patient was admitted after being found severely anemic with dark bloody stools and more frequent seizures. It was noted that the patient had significant blood loss and had hemorrhagic shock requiring 6 units of packed red blood cells and vasopressor support. The patient underwent endoscopy with control of bleeding, but developed supraventricular tachycardia. The patient failed to return to his usual state of mental activity and his anti-epileptic therapy was adjusted. An eeg showed subclinical seizure activity. On the day prior to death, the patient developed persistent heart rates in the 170s to 180s that did not respond to cardizem, adenosine or amiodarone and he became more hypotensive. It was noted that the patient's family decided on comfort measures only, and the patient ultimately expired. It was noted that the vns was interrogated and was functioning appropriately. The esophagogastroduodenoscopy showed a large duodenal ulcer. Echocardiogram showed hyperdynamic left ventricular systolic function and eeg showed abnormal eeg consistent with both a generalized seizure disorder and possibly a focal area of dysfunction in the right temporo-parietal region. The final diagnoses was listed as acute upper gastro-intestinal bleed due to large duodenal ulcer, complex seizure disorder with subclinical seizure activity, acute blood loss anemia with hemorrhagic shock, supraventricular tachycardia, hypertension, hypothyroidism.
 
Event Description
It was reported that the vns patient passed away. No additional information was provided at the time of initial report. An online obituary was found and noted that the patient passed away at the hospital. Further follow-up revealed that the patient was admitted to the hospital with a low hemoglobin and hematocrit and tachycardia; however, a cause of death was not yet known. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530505
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #2 on: May 19, 2018, 02:41:27 AM »

Model Number 102
Event Date 08/07/2013
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect aware date. The correct aware date for the previous report is (b)(4) 2014.
 
Event Description
It was reported that the patient passed away. No other information was provided at the time of initial report. The patient's last known physician was contacted and reported that the patient had not been seen in over a year and that the death was not known. Attempts to obtain additional information are in progress. No additional information has been received to date.
 
Event Description
The vns patient¿s death certificate was received indicating that the patient passed away while in the hospital. No autopsy was performed and the patient¿s remains were buried. The immediate cause of death is listed as ¿multi-organ failure¿ with sequentially listed causes contributing to the patient¿s death including: ¿status epilepticus¿ and "epilepsy". Secondary health conditions contributing to the patient¿s death include: ¿down¿s syndrome¿, ¿obstructive sleep apnea¿, ¿hypothyroidism¿ and ¿obesity¿.
 
Event Description
Additional information was received stating that the vns patient was hospitalized due to septic shock in the presence of intractable seizures. During the course of inpatient treatment, the patient developed multi-organ failure including acute on chronic respiratory failure and kidney injury. The patient's caretakers elected to withdraw medical care and institute comfort-only treatment. The patient passed away shortly thereafter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388738
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #3 on: May 19, 2018, 02:42:30 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/30/2015
Event Type  Malfunction   
Event Description
Follow-up with the physician's office showed that they do not feel that the vns device made the patient's seizures worse. External factors of stress and possible thyroid disease may have contributed to the seizures. Their records show the vns device to be operational. The patient was always able to perceived stimulation and it is only a painful sensation now. According to the physician, the etiology of the pain continues to be unclear. The feel it is unlikely related to vns. The emg is negative and patient was referred to pcp for evaluation of musculoskeletal pain. The nurse clarified what was mean by the "magnet was not working" by stating that they do not suspect any issues with the patient's magnet and have discussed magnet technique as well. She was not sure if the patient maybe could not feel the stimulation at times but the magnet and vns has worked for the patient and everything from their records shows that the device is functioning normally.
 
Event Description
Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation", "muscle spasm(s)", and "pain"). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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 battery, 2. 755 volts, shows an ifi=yes condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Patient underwent generator replacement on (b)(6) 2016 due to battery depletion. The explanted generator was received on 7/29/2016. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative

Event Description
On (b)(6) 2015, the patient reported that she is having an increase in seizures. The patient has been cleared of any cardiac or other medical causes for her symptoms. The nurse turned down the dosing at the most recent visit. The nurse wishes to keep decreasing the settings and perhaps even disable her device. However, the patient states she has always had excellent seizure control from vns and refuses disablement. Further follow-up with the patient's physician showed that the patient is very vague in her descriptions of her adverse events. The physician states it is unclear if the increase in seizures is related to vns therapy. The patient has had no obvious medication changes that would be contributing. The physician stated that it is hard to assess the seizures as it isn't always clear from her report if she had an actual epileptic seizure or just thinks that she did. Therefore baseline level is hard for him to assess. According to the physician, at this point, any surgical intervention would be based on patient request only.
 
Event Description
It was reported that the vns patient was experiencing pain and muscle spasms in her neck and shoulder after her device settings were increased. The device settings were subsequently decreased and the pain resolved; however, the patient began experiencing an increase in seizures reported by the patient to be above pre-vns baseline levels. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Further follow up indicated that the patient¿s settings were lowered, and the neck and shoulder pain subsided. The vns was interrogated and results again showed normal device function. The patient then experienced an increase in seizures reportedly above the vns pre-therapy levels. An x-ray was reviewed by the patient¿s neurologist, and the leads appeared intact, it was unknown what the cause for the patient¿s pain. No additional relevant information has been received to date.
 
Event Description
On (b)(6) 2015 it was stated that all non-vns issues were ruled out for the patient's pain. The patient continues to have pain when she turns her head to the left; however, she is unable to correlate the pain to stimulation. It was noted that the patient's increase in seizures were temporary and did not start with the pain. Further attempts have been made for additional information but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4723849
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #4 on: May 19, 2018, 02:43:22 AM »

Device Problem High impedance
Event Date 02/26/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014. The patient¿s generator was explanted, but the lead remained implanted due to concerns of potential damage to the patient¿s nerve. The explanted generator was discarded. A new generator and lead were implanted on the right side of the patient¿s body.
 
Event Description
It was reported that the patient will be seen by ent for thyroid biopsy and evaluation and when that is complete the patient will be scheduled for generator and lead replacement. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a potential lead discontinuity. Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Information was received indicating that an additional lead segment was explanted from a former abandoned lead during re-implant of a new left-sided lead in this patient on (b)(6) 2015 (see mfr report# 1644487-2015-05651). The lead was cut next to the nerve and the electrode coils remained implanted. The explanted lead segment was discarded by the explanting hospital. It was clarified that during the previously reported procedure on (b)(6) 2014 a segment of this same lead was explanted and discarded by the explanting hospital.
 
Event Description
It was reported that the vns patient was experiencing and increase in seizures. The patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 9405 ohms). X-rays were provided to the manufacturer for review and the cause for the reported events could not be determined. There was a suspect area near the anchor tether which may be a possible break. There was nothing additional seen that would indicate there was any damage to the generator or lead. As the entire lead could not be assessed from the x-rays provided, continuity in that portion of the lead cannot be confirmed. Attempts for additional relevant information were made, but have been unsuccessful to date. No known interventions have occurred to date.
 
Event Description
Additional information was received that the explanted generator and lead were discarded and will not be returned to the manufacturer for evaluation.
 
Event Description
Additional information was received indicating that the vns patient¿s increase in seizures was below pre-vns baseline levels. The patient was seizure free since (b)(6) 2011. The patient was now having 12 seizures per day that were increasing in intensity and duration. The patient was referred for surgery but no known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3705843

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #5 on: May 19, 2018, 02:44:09 AM »

Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported that a patient developed cardiomyopathy. The device was programmed off and the patient was given lisinopril and coreg as a result. In 2008, the patient began to notice shortness of breath and decrease in energy. In 2009, the patient had an echocardiography which was abnormal and at that point, the patient was diagnosed with cardiomyopathy. The patient was diagnosed with ankylosing spondylitis and is taking methotrexate and endbrel for this condition. The patient is also morbidly obese and has hypothyroidism. The patient had ecg in 2005 that showed a nonspecific t wave abnormality and this procedure was repeated the next day with results that the nonspecific t wave abnormality improved. The device has been programmed off so that further testing can be performed. It is unk whether or not the cardiomyopathy is related to the device. The patient will follow up with the physician in 2010 at which time, the echocardiogram will be repeated. Good faith attempts to obtain additional information are in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1565031
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #6 on: May 19, 2018, 02:45:03 AM »

Model Number 300-20
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was later reported on (b)(6) 2013 that the patient recently passed away due to cancer. The patient's obituary was found online and it stated that the date of death was (b)(6) 2013. It was reported that it was believed that the patient passed away from the thyroid cancer and that the death was not related to vns.
 
Event Description
Additional information was received on (b)(4) 2012 when it was reported that the vocal cord paralysis was first observed in early (b)(6) 2012; exact date not provided. The physician stated that the patient was seen by the radiology department and it was determined on (b)(6) 2012 that the patient has thyroid cancer. The patient is therefore being treated for thyroid cancer. The vocal cord paralysis was noted to be not related to vns stimulation. The patient was evaluated by an ent (ear, nose, and throat) physician and the outcome of the evaluation was that the patient has thyroid cancer. The physician does not think the thyroid cancer has anything to do with vns. No programming or medication changes preceded the onset of the vocal cord paralysis. The patient does not have a medical history of vocal cord paralysis prior to vns.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the vns patient was referred two weeks prior for an ear, nose, and throat evaluation as the patient was experiencing bilateral vocal cord paralysis and the neurologist it was possibly related to vns. No further information was provided at the time. It was previously reported that the vns patient was diagnosed by her ear, nose, and throat physician (ent) with vocal cord paralysis in (b)(6) 2010. The ent reported to the neurologist that the vocal cord paralysis was viral in nature and not related to vns. System diagnostics were performed on (b)(6) 2010, which showed the device to be functioning properly. The neurologist lowered the patient's frequency to see if that would affect the patient, but did leave her programmed on as he did not believe the paralysis was related to vns at that time. Attempts for additional information from the physician are underway but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852306
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7 on: May 19, 2018, 02:46:01 AM »

Event Date 06/03/2011
Event Type  Injury   
Event Description
It was reported that the vns patient has been experiencing "vocal cord issues" since implant. The patient was seen by an ent physician who indicated that he believes the lead was implanted too close to the vocal cords. It was also noted that the patient has not seen much efficacy since implant. The patient was reportedly going to see the implanting surgeon for further evaluation however the surgeon's office indicated that the patient has not been seen or made an appointment. Attempts for further information from the neurologist's office have been unsuccessful to date. Attempts for the product information were unsuccessful.
 
Event Description
Additional information was received indicating the patient's vocal cord issue has resolved.
 
Event Description
On (b)(6) 2012, additional information was received indicated that the patient had hoarseness and awakening at night with vns stimulation noted in (b)(6) 2011. It was confirmed that vocal cord issues were related to electrodes being placed too close to the larynx. No hoarseness was noted (b)(6) 2011. On (b)(6) 2011, the hoarseness was intermittent but then constant on in (b)(6) 2011. A note indicated the hoarseness appeared to have resolved following the thyroidectomy. The thyroid issues were not believed to be related to vns.
 
Manufacturer Narrative

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".
 
Manufacturer Narrative
Event date, corrected data: previously submitted mdr indicated an incorrect event date. The patient's physician believes that the vocal cord issues are related to the electrodes being placed too close to the larynx at the time of implant; therefore, the event date is the date of implant: (b)(6) 2011. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603575
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #8 on: May 19, 2018, 02:46:51 AM »

Model Number 105
Event Date 03/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient developed apathy and anorexia after his device was first programmed on. The physician is looking at multiple possible etiologies. The patient has pituitary dysfunction due to six brain surgeries for a pinealoma. The patient¿s device was programmed off during an office visit on (b)(6) 2014. Further follow-up revealed that the patient was last seen on (b)(6) 2014. At that time, it was noted that the patient had gained weight and had improved mental status since the device was programmed off. The patient was previously overweight and had been very talkative. Clinic notes from the patient¿s office visit stated that the patient¿s issues were likely not related to vns as the patient¿s device settings were very low. It was also noted that the patient had recently moved, and this may have had an effect on the reported events. The patient¿s device was to remain programmed off until the patient¿s next office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3792218
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #9 on: May 19, 2018, 02:48:05 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/04/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The physician did not believe that the patient had vocal cord paralysis, but instead just had hoarseness. The dysphagia was occurring with stimulation, and the patient felt the painful stimulation at the neck and electrode and generator incision sites. Diagnostic results from (b)(6) 2015 were within normal limits and did not indicate a device malfunction.
 
Event Description
It was reported that a patient was experiencing tightness in her chest, vocal cord paralysis, dysphagia, and sleeping difficulties due to the tightness in her chest. These events started after she had thyroid surgery in (b)(6) 2014, but they just started getting worse recently. The physician programmed the device off on (b)(6) 2015 to determine if the issues were related to stimulation, but left the patient's magnet output current at 1. 5ma. The physician attempted to perform system diagnostics, but the patient felt pain during the stimulation and was unable to complete the test. The physician planned to turn the patient's device back on at the next appointment, but the patient did not go to the appointment because she was no longer feeling tightness in her chest, the dysphagia had resolved, her voice had come back, and she was no longer feeling painful stimulation. The patient did not want to have her device turned on for at least a month because she did not want to experience the side effects and she could not afford to go to another appointment. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5171609
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #10 on: May 19, 2018, 02:50:52 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 01/14/2017
Event Type  Death   
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.
 
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as metabolic encephalopathy is not expected to be related to the vns.

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: 64492


« Reply #11 on: May 19, 2018, 02:52:00 AM »

Model Number 101
Device Problem No Information
Event Date 07/27/2010
Event Type  Death   
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2004 and the patient's cause of death was potential sudep with epilepsy, unspecified, and sequelae of intracranial injury and other accidents. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of definite sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported by the physician's office that the patient has died due to an unknown reason. No other information regarding the patient's death was known by the office or the patient's last known physician. Attempts for a copy of the patient's death certificate have been unsuccessful to date.
 
Event Description
The requested death certificate has been received. The cause of death is listed as "sepsis", "cholecystihs", and "cholerithiasis" as contributing causes. Other significant contributing conditions were listed as: "aspiration pneumonia, seizure disorder, adrenal insufficiency, hypothyroidism. " no autopsy was performed. The manner of death is listed as "natural. " the patient died as an inpatient. The patient's vns is believed to have been buried with the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2265175
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #12 on: May 19, 2018, 02:52:49 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
Logged
Pages: [1]   Go Up
Print
Jump to: