Pages: [1]   Go Down
Print
Author Topic: Lipids  (Read 680 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« on: July 14, 2018, 02:26:57 AM »

Event Date 12/17/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient experienced short (3-4 seconds) ictal bradycardia (20-30 beats/min). It was noted that the patient also has a pacemaker implanted. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the patient's treating physician. The patient did not have a pacemaker as previously reported, but rather, the inquiry was for feasibility of having both a vns and a pacemaker because the patient had a vns at this time. No additional information was provided as to whether their bradycardia event was related to vns.
 
Event Description
It was additionally reported that the patient unexpectedly died last (b)(6) 2014, shortly after an emu admission. Autopsy was requested, official results are pending. Sudep is highly suspected as he had medically intractable secondarily generalized seizures, apnea, morbid obesity, ictal bradycardia and lived alone. This was reported and will continue to be reported on medwatch report number: 1644487-2015-04180. The patient (b)(6) male with history of obesity, hyperlipidemia, apnea nos, mdd, bph and poorly localized focal seizures status post vns placement (2011). Seizure onset was at (b)(6). Hypothesis for seizure onset was within the right frontal region (possible anterior cingulate vs sma) based on semiology and eeg. Mri and pet were always normal. During the last emu admission at wla va, he was noted to have 2-6 seconds of 20-30 beats/min bradycardia that resolved alone at the beginning of every clinical seizure. Their physicians best interpretation is that these ictal bradycardia events were seizure driven. There are no other records of him available and his following physician did not know if his ictal bradycardia events were described in the past (prior to vns implantation). Although he suspected he had this bradycardia events for years, given that he once had (remote past) a pacemaker placed (later removed) due to unclear bradycardia events nos.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4417998
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #1 on: July 14, 2018, 02:28:08 AM »

Model Number 102
Event Date 11/01/2011
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently referenced the wrong mfr report number for the sleep apnea event. The correct mfr report number is 1644487-2012-00596 for the sleep apnea event.
 
Event Description
On (b)(6), 2012 clinic notes from a vns treating psychiatrist were received by the manufacturer. Review of the clinic notes dated (b)(6), 2011 revealed that he patient's suicidal thoughts were at baseline. The patient stated that the closest he has ever come to killing himself is holding a gun to himself years ago but did not pull the trigger. There is no history of suicide attempts according to the clinic notes. Clinic notes dated (b)(6), 2011 reveal that the patient has increased suicidal ideation and he wanted to kill himself bad. The following clinic notes dated (b)(6), 2011 stated that the suicidal thoughts are pretty up there but about at baseline. On (b)(6), 2011 his suicidal thoughts are maybe a little worse than baseline. He denies plan/intent to harm self; he is thinking that he wants to die. The patient's longtime friend and neighbor had passed away from cancer that week. The clinic notes further state that this is a bad time of the year for him as it was this time last year that he was in the hospital and got out the day before (b)(6). Clinic notes dated (b)(6), 2011 state that his suicidal thoughts are stable; he has thoughts of shooting himself intermittently but denies plan or intent to do so. He does not want to be admitted. On (b)(6), 2011 clinic notes stated that the patient says he is tired of living and expresses that it is just a matter of time before he kills himself the patient refuses to go to inpatient because he said its stupid up there. His thoughts of harming himself were at baseline. In clinic notes dated (b)(6), 2011 the patient stated my thoughts were bad a couple of days ago, he did not take any steps to harm himself at that time; he just stated his thoughts were bad. The patient reported his thoughts are back to baseline that day and he does not have any plan or intent to harm or kill himself. Clinic notes dated (b)(6), 2011 again state that the patient's thoughts of harming himself were bad a few days ago and are at baseline. The patient states he is just having thoughts and has not taken steps to harm himself. The patient was reported to be talking with a surgeon about vns removal and the patient stated he has not been feeling vns stimulation as well as in the past. On (b)(6), 2011 the patient stated he is not doing well and was worse than last week. The patient expressed repeatedly that he is just tired of living. On (b)(6) 2012's clinic notes the patient had a wall fall on him and he stated that he wished it would have killed him. Clinic notes dated (b)(6), 2012 stated that the patient has thoughts of shooting himself and wanting to die daily that is at baseline levels but he denies any plan or intent to harm himself. (b)(6), 2012 the patient continues to be very depressed and stated that he has not been sleeping well in general at nights. He is not sure if his suicidal thoughts are at baseline but there are still there. Clinic notes dated (b)(6), 2012 reveal that the generator is not working and is broken; the patient is making a decision about whether he will get vns again. On (b)(6), 2012 the patient was sent to the emergency department to be evaluated for voicing suicidal thoughts. The patient reported thinking about suicide daily but denied a plan and says he is not close to harming himself. He reported to the psychiatrist that he does not feel that he needs to be admitted to the hospital and does not want to be admitted. The patient's wife reported that she has not noticed any acute change in him and she did not expect him to be sent to the emergency department based on how he was this morning. She stated that he has not made any statements about harming himself lately. The psychiatrist stated that the patient appears to be at baseline. However, according to the psychiatrist the patient has generally been doing worse in terms of depression and suicidal thoughts for the last 6 months. The patient states that even this new baseline is only a smidge worse than his previous state. The psychiatrist stated that the fact that he saw a resident in the clinic who does not know him, may be part of why he was sent to the emergency department that day. The patient admits to baseline thoughts of harming himself with intermittent thoughts of shooting himself, but denies plan or intent to harm himself at this point. He does not want to be hospitalized nor does he feel he needs to be hospitalized. The clinic notes state the patient has a history of chronic obstructive pulmonary disease, obstructive sleep apnea (reported on mfr. Report # 1644487-2012-00597), diabetes, dyslipidemia, and hypertension. The psychiatrist later reported that the increased depression and suicidal ideations were first noticed recently, (b)(6) 2011, and occurred after the vns stopped working. The physiatrist further states that the patient's sleep apnea probably contributed to the increased depression and suicidal ideations (reported on mfr. Report # 1644487-2012-00597). No patient manipulation or trauma occurred that is believed to have caused or contributed to the altered perception of stimulation. The patient's most recent programmed settings are: output=2ma/frequency=30hz/pulse width=300usec/on time=30sec/off time=1. 1min/magnet output=0ma. The last system and normal mode diagnostics tests showed output=ok/lead impedance=ok/dcdc=2/eri=no and output=ok/lead impedance=ok/dcdc=2/eri=no respectively. The psychiatrist stated that the increased depression level is back to pre-vns baseline levels and the suicidal ideations levels is also back to pre-vns baseline levels. The psychiatrist also clarified that what was meant by the vns is broken is that the generator battery is depleted. On (b)(6), 2012 they were unable to interrogate the patient's generator due to the device being at end of service. A battery life calculation had been performed which revealed negative years until eri=yes.
 
Manufacturer Narrative

Event Description
The clinic notes state the patient has a history of chronic obstructive pulmonary disease, obstructive sleep apnea (reported on mfr. Report # 1644487-2012-00596), diabetes, dyslipidemia, and hypertension. The physiatrist further states that the patient's sleep apnea probably contributed to the increased depression and suicidal ideations (reported on mfr. Report # 1644487-2012-00596).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2478470
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #2 on: July 14, 2018, 02:29:44 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
Logged
Pages: [1]   Go Up
Print
Jump to: