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dennis100
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« on: May 11, 2011, 01:00:43 PM »

Event Date 04/29/2010
Event Type Death
Patient Outcome Death;
Event Description
It was reported that a vns pt passed away. Previously, the pt had reported an increase in depression and was looking for a vns physician as it had been several years since the last time he had his vns device checked. The increased depression was reported in mdr 1644487-2010-00388. The pt made an appointment to see a physician; however, the pt did not make the appointment nor was the appointment rescheduled. Good faith attempts to obtain additional information surrounding the pt's death are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032662
« Last Edit: February 25, 2017, 02:18:07 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 11, 2011, 01:01:13 PM »

Event Date 05/09/2001
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Rptr indicted that device was explanted per pt request. Pt was having increased depression. Physician did not believe that increased depression was caused by the ncp system. Further investigation revealed that the generator had migrated into the pt's neck. Pt reported that physician implanted both the generator and the led through one incision in pt's neck.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355916
« Last Edit: February 25, 2017, 02:18:17 AM by dennis100 » Logged
dennis100
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« Reply #2 on: May 11, 2011, 01:01:43 PM »

Event Date 05/08/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Initial report received in 2000 stated that pt was experiencing mandibular and neck pain with stimulation. Additionally, it was reported that when parameters were reduced, the pain resolved but pt's depression worsened. The pt requested that the output current be increased. X-rays were normal. Revision surgery to insulate the trigeminal nerve was considered. At a later office visit 1 month later, the pt stated that the pain was bearable and had no complaints of depression. At that time, plans for surgical revision were abandoned. 5 months later: cyberonics received a report that during revision surgery, the lead was inadvertently cut. A replacement lead was implanted. The explanted was returned for analysis. Product analysis did not reveal any anomalies nor abnormalities that would have and adverse effect on device performance. In 2001, cyberonics received a report that post-revision surgery the pain had resolved but the pt has again been experiencing pain for several weeks and that the pt also has difficulty sleeping. Another revision surgery is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=342444
« Last Edit: February 25, 2017, 02:18:29 AM by dennis100 » Logged
dennis100
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« Reply #3 on: May 11, 2011, 01:02:12 PM »

Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
Reporter indicated that depression study patient was suffering from worsening depression over the last four weeks. The worsening depression reportedly led to thoughts of suicide resulting in admittance to local psychiatric hospital. Electro convulsive therapy treatment is planned according to local psychiatrist. Reporter indicated that the worsening depression was probably due to the "natural" cycling of the bipolar type ii disorder. Date of implant is not known at this time. Stimulation was initiated in 09/02 and there has been no interruption in stimulation. Reporter indicated that there was no relatiosnhip to implantation but a possible relationship to stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=444129
« Last Edit: February 25, 2017, 02:18:45 AM by dennis100 » Logged
dennis100
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« Reply #4 on: May 12, 2011, 03:30:45 AM »

Event Date 10/27/2003
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that depression pt was hospitalized for worsening of depression. It was reported that the event was not related to the vns implant or to stimulation and that the vns had never helped that pt's depression. Device diagnostic testing was within normal limits, indicating proper device function. Treating psychiatrist indicated that stopping the medication "nefadar" may have contributed to the pt's worsening depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=499080
« Last Edit: February 25, 2017, 02:18:58 AM by dennis100 » Logged
dennis100
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« Reply #5 on: May 12, 2011, 06:44:05 AM »

Event Date 09/15/2003
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that vns patient was hospitalized for worsening of depression. The patient was hospitalized for 11 days and is reportedly doing better, but still not well. Treating psychiatrist indicated that the event was not related to the vns therapy and that no intervention is required.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=495245
« Last Edit: February 25, 2017, 02:19:13 AM by dennis100 » Logged
dennis100
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« Reply #6 on: May 13, 2011, 07:21:16 AM »

Event Date 04/23/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that depression study patient was hospitalized due to exacerbation of depression. It was reported that the event was severe, but was resolved with treatment. Study coordinator indicated that the event was not related to the vns therapy, but was due to social conflicts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=554693
« Last Edit: February 25, 2017, 02:19:27 AM by dennis100 » Logged
dennis100
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« Reply #7 on: May 14, 2011, 02:52:57 PM »

Event Date 01/01/2006
Event Type Injury
Patient Outcome Hospitalization;
Event Description
In 2005, i have a vagus nerve stimulator implanted for treatment-resistant depression. The device had to be explanted because it had become infected. I was hospitalized for three days and kept on antibiotics. In 2005 another vagus nerve stimulator was implanted. Since the surgery, i have suffered from left vocal cord paralysis, with difficulty speaking. On 02/28/2006 the stimulator was activated to a level of 1. 0 milliamperes. Four days later, my depression increased dramatically in severity. The severe depression lasted two days. The past three days have not been as bad, although i am still more depressed than i had been prior to activation of the device. My depression tends to fluctuate, so the increase in severity may not have been caused there was a very high incidence of increased depression and suicide attempts during the clinical trials. In one 8-week study, 57 percent of participants reported increased depression, and 20 percent attempted suicide. There was no control group, so it was impossible to say whether the worsening of symptoms was caused by the device (see letter from public citizen to the fda urging that vagus nerve stimulator not be approved for treatment of depression. http://Http://www. Citizen. Org/publications/release. Cfm?id=7351.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=694296
« Last Edit: February 25, 2017, 02:19:38 AM by dennis100 » Logged
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« Reply #8 on: May 15, 2011, 03:37:57 AM »

Event Date 05/01/2006
Event Type No Answer Provided
Event Description
Reporter states that she had implant placed to treat her epilepsy. The device has been approved to treat depression. However, reporter says since having the implanted device placed, she has become "depressed. " curently the reporter takes antidepressants prescribed by her family doctor. She would like to report that this implant is the reason for her depression. As she had never had depression, until she was implanted with this device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=768113
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dennis100
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« Reply #9 on: May 15, 2011, 11:45:56 AM »

Event Date 12/01/2006
Event Type Injury
Patient Outcome Required Intervention; Other
Event Description
It was reported that patient was very depressed. Further follow up with the treating physician indicated that the patient's depression had actually gotten worse and after much discussion, they decided to turn the vns therapy device off. Physician indicated that the patient's depression was worse than it ever has been, even prior to vns implantation. The patient's depression worsened sometime around winter. There have been no changes to her medication and no stresses that could be causing the worsening depression. Device diagnostics were okay, which indicates the device is functioning properly. The cause of the worsened depression is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842407
« Last Edit: February 25, 2017, 02:20:05 AM by dennis100 » Logged
dennis100
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« Reply #10 on: May 15, 2011, 11:46:46 AM »

Event Date 01/10/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated patient experienced worsening depression. It is unknown if the patient condition is worse than is was pre-vns. Diagnostics are not available. The device has been turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=951136
« Last Edit: February 25, 2017, 02:20:19 AM by dennis100 » Logged
dennis100
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« Reply #11 on: May 15, 2011, 11:47:45 AM »

Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated "vns has not helped at all" in addition to worsening depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=953356
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dennis100
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« Reply #12 on: May 15, 2011, 11:48:39 AM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
A pt self-reported to mfr that worsening depression and mania events were being experienced. F/u with current treating physician confirmed these events may have occurred due to the pt's disease process and history. Pt did not report these events to the treating physician. The treating physician stated the pt is currently doing well and remains on vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841524
« Last Edit: February 25, 2017, 02:20:38 AM by dennis100 » Logged
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« Reply #13 on: May 15, 2011, 03:50:09 PM »

Event Date 02/14/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt "doesn't think vns is working, has never felt any better, feels he is going steadily down, getting more depressed, wants it turned off". Pt's worsening depression needed medical intervention and pt was hospitalized twice. Information rec'd from the pt's physician reported that the pt has a history of being an "alcoholic" and issues with "substance abuse" and is "non compliant with meds and with appts to dose vns". The reporter did not indicate an allegation of a device malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841352
« Last Edit: February 25, 2017, 02:20:55 AM by dennis100 » Logged
dennis100
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« Reply #14 on: May 16, 2011, 04:03:46 AM »

Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that she has worsening depression. It is unk if symptoms are worse than before vns therapy. Results of device diagnostics are unk. The pt is currently not being treated by a physician; therefore, attempts to obtain further info cannot be done. The cause of the pt's worsening depression is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=967868
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dennis100
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« Reply #15 on: May 16, 2011, 04:04:29 AM »

Event Date 04/05/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a pt was experiencing worsening depression, possibly related to vns therapy stimulation. Device parameter settings and medications were changed. No further info is available from the reporter. Vns diagnostics tests were not performed due to possible unblinding of study pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=845077
« Last Edit: February 25, 2017, 02:21:11 AM by dennis100 » Logged
dennis100
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« Reply #16 on: May 16, 2011, 06:00:35 AM »

Event Date 05/01/2007
Event Type Injury
Patient Outcome Other;
 Event Description
Reporter indicated that the pt was implanted in 2007. Four weeks later, the pt called in to report that the vns was worsening his depression, causing him to be sleepy and tired all the time, and that he is experiencing some mild gastrointestinal problems. The physician stated that his depression has worsened above pre-vns levels. The pt used the magnet to disable the device and stated that he felt much better, his gastrointestinal problems went away, and that his depression improved. The physician further explained that the pt has not had any medication changes or any external factors which could be contributing to the worsening depression. The physician indicated that he would increase the pt's settings to see if an improvement is seen or will otherwise have the device turned off. The physician also stated that he can't conclusively determine that the symptoms are vns related until he tries to increase the settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=871546
« Last Edit: February 25, 2017, 02:21:32 AM by dennis100 » Logged
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« Reply #17 on: May 16, 2011, 08:30:06 AM »

Event Date 01/01/2007
Event Type Malfunction
Patient Outcome Other;
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated that a vns patient was experiencing worsening depression above pre-vns baseline. It was reported that medications have not been changed recently. The event has not been confirmed by a physician, and attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=880932
« Last Edit: February 25, 2017, 02:21:51 AM by dennis100 » Logged
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« Reply #18 on: May 16, 2011, 12:31:09 PM »

Event Date 03/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that a patient implanted for depression had a "worsening depression. " due to the depression, the patient had a change in their device parameters and their medication dose and schedule. The depression was reported as "worse than she ever had been". The depression was reported as a single episode that was severe and definitely replated to the patient's stimulation. Additional information received indicated that the patient's device settings were decreased due to an "arm twitch", resulting in the worsening of depression. Programming changes were made to return the patient to their previous settings and the depressive event resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=892210
« Last Edit: February 25, 2017, 02:22:11 AM by dennis100 » Logged
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« Reply #19 on: May 17, 2011, 03:49:45 AM »

Event Date 08/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that a vns patient has experienced worsening depression and worsening agoraphobia. Previous system diagnostics resulted in normal values indicating proper device functioning. The patient has had a medication change in attempts to improve her depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=914782
« Last Edit: February 25, 2017, 02:22:28 AM by dennis100 » Logged
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« Reply #20 on: May 18, 2011, 02:47:26 AM »

Event Date 10/26/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt had the vns therapy system explanted due to pain at the generator site and worsening depression. The explanted products have been requested for return. Attempts for further info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948590
« Last Edit: February 25, 2017, 02:22:44 AM by dennis100 » Logged
dennis100
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« Reply #21 on: May 18, 2011, 02:48:02 AM »

Event Date 10/01/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt was in the hosp for unk reasons and was experiencing an increase in depression. Pt implanted with the vns device for seizures. Pt's pre-vns baseline depression level is unk to mfr at this time. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948002
« Last Edit: February 25, 2017, 02:22:58 AM by dennis100 » Logged
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« Reply #22 on: May 18, 2011, 02:48:47 AM »

Event Date 09/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a patient was initially doing well with vns, but recently has experienced worsening depression, relationship to pre-vns baseline unknown. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=937593
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dennis100
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« Reply #23 on: May 18, 2011, 06:54:09 AM »

Event Date 10/29/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial reporter indicated that the patient was having worsening depression. It is unknown if the depressive event is worse than the patient had pre-vns implantation. The event was reported as being "unlikely" related to vns stimulation. No interventions were taken. Good faith attempts will be made for additional information surrounding the depressive event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=973905
« Last Edit: February 25, 2017, 02:23:19 AM by dennis100 » Logged
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« Reply #24 on: May 18, 2011, 01:15:12 PM »

Event Date 01/29/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that her depression was worse than before she was implanted with the vns therapy system. Attempts for additional information from the reporter's attending physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1003285
« Last Edit: February 25, 2017, 02:23:35 AM by dennis100 » Logged
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« Reply #25 on: May 18, 2011, 01:15:46 PM »

Event Date 01/17/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported to the manufacturer that the patient's depression was worsening. Further investigation revealed that the reported condition started four days after vns implantation surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1001064
« Last Edit: February 25, 2017, 02:23:48 AM by dennis100 » Logged
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« Reply #26 on: May 18, 2011, 01:16:33 PM »

Event Date 02/07/2008
Event Type Malfunction
Event Description
Rptr indicated his depression was worse than his pre-vns baseline depression level and it was felt the vns was the cause. All attempts for further info from the rptr's physician regarding the increased depression have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018189

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dennis100
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« Reply #27 on: May 18, 2011, 01:17:11 PM »

Event Date 10/10/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
It was reported that a patient's depression is worse than post-op. It is unknown if the depression level is above or below pre-vns baseline level. It was also reported that diagnostic testing resulted in high lead impedance at a routine office visit. However, the output status was ok indicating the patient is receiving the intended therapy. No device issues are suspected. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1017629
« Last Edit: February 25, 2017, 02:24:03 AM by dennis100 » Logged
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« Reply #28 on: May 18, 2011, 01:17:50 PM »

Event Date 02/07/2008
Event Type Malfunction
Patient Outcome Other;
Event Description
Reporter indicated high lead impedance readings were obtained for a pt during an office visit. The pt is also experiencing worsening depression. It is unk if the depression is worse than pre-vns baseline levels. X-rays reviewed by the manufacturer did not reveal any obvious lead discontinuities, but the film quality was very poor. It is unk if the pt had any trauma or manipulated the vns device. Additional x-rays and possible surgery are planned. Attempts for further information are in progress. The reporter has been advised to disable the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009804
« Last Edit: February 25, 2017, 02:24:15 AM by dennis100 » Logged
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« Reply #29 on: May 19, 2011, 10:14:42 AM »

Event Date 06/13/2008
Event Type Injury
Event Description
Reporter indicated that a vns pt experienced worsening depression and was admitted to the hosp as a result. The vns settings were increased at that time in response to the worsening depression event. It is unk if the pt's depression was above or below pre-vns baseline levels. Attempts for additional info from a medical professional have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1074561
« Last Edit: February 25, 2017, 02:24:30 AM by dennis100 » Logged
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