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dennis100
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« Reply #30 on: May 20, 2011, 02:36:54 AM »

Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt was experiencing an increase in depression that was above the pre-vns baseline. Doctor indicated that the increase was directly related to the vns therapy. They plan to lower the device on time, off time, and output current in order to deal with these events. Results of effectiveness of intervention have not been reported and no other interventions are planned to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155249
« Last Edit: February 25, 2017, 02:11:06 AM by dennis100 » Logged
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« Reply #31 on: May 20, 2011, 12:30:42 PM »

Event Date 07/11/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a vns patient's generator was disabled due to the pt's inability to tolerate hoarseness, coughing, and an increase in depression. The patient's depression level prior to being implanted is unknown. The physician has attempted to "play around with the settings; however the pt would sometimes come back on the same day or the next day to get it changed again. " an ent determined the hoarseness is not vocal cord paralysis. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1104308
« Last Edit: February 25, 2017, 02:11:26 AM by dennis100 » Logged
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« Reply #32 on: May 20, 2011, 12:31:24 PM »

Event Date 07/29/2008
Event Type Malfunction
Patient Outcome Required Intervention
Event Description
It was reported to mfr that the vns pt was seen for a follow up visit, due to worsening depression over the last two weeks, and pain in the chest. The pt has denied any recent trauma, however, the patient mentioned that she mows the lawn, which is on a very steep incline and experienced the chest pain during this activity. Diagnostic testing was performed and revealed high lead impedance, end of service status set to no. The physician subsequently disabled the device. X-rays were sent to manufacturer to review, and a lead discontinuity was observed following the fourth tie-down after the strain relief loop in the neck region. Attempts to obtain additional information for the treating physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172179
« Last Edit: February 25, 2017, 02:11:42 AM by dennis100 » Logged
dennis100
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« Reply #33 on: May 20, 2011, 12:32:02 PM »

Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported that the pt was experiencing an increase in depression. It is unknown whether it is above or below the pre-vns baseline. All attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213115

« Last Edit: February 25, 2017, 02:12:05 AM by dennis100 » Logged
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« Reply #34 on: May 20, 2011, 12:34:15 PM »

Event Date 09/08/2008
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Initial reporter indicated that a vns pt implanted for depression was admitted into hosp for treatment of suicidal ideation and worsening depression. The treating physician felt it could possibly be related to vns stimulation. The pt has been discharged from the hosp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1193927
« Last Edit: February 25, 2017, 02:12:18 AM by dennis100 » Logged
dennis100
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« Reply #35 on: May 20, 2011, 12:34:53 PM »

Event Date 10/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the mfr that the patient has been experiencing an increase in depression. It was also indicated that the patient was hospitalized. The relationship between the worsening depression and vns therapy is unk at this time. Good faith attempts to obtain additional info regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1242943
« Last Edit: February 25, 2017, 02:12:35 AM by dennis100 » Logged
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« Reply #36 on: May 23, 2011, 01:54:06 AM »

Event Date 01/12/2009
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a vns therapy pt is experiencing an increase in depression. The patient's pre-vns depression level is unknown. The patient was also experiencing some adverse events reported on medwatch number 1644487-2009-00274, and subsequently underwent vns generator replacement surgery. Good faith attempts to obtain additional information and the product for analysis have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310983
« Last Edit: February 25, 2017, 02:12:53 AM by dennis100 » Logged
dennis100
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« Reply #37 on: May 23, 2011, 01:54:59 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported by a patient implanted for depression that she was experiencing an increase in depression. When diagnostics were performed, the device registered high impedance. It is unknown which diagnostics were performed. All attempts for more information have been unsuccessful. The relationship between the increase in depression and vns therapy is currently unknown

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1363434
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dennis100
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« Reply #38 on: May 23, 2011, 01:55:29 AM »

Event Date 02/03/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated vns therapy was experiencing increased depression, and was given medication. The patient's pre-vns depression level is unknown. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1336473
« Last Edit: February 25, 2017, 02:13:13 AM by dennis100 » Logged
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« Reply #39 on: May 23, 2011, 10:23:28 AM »

Event Date 04/03/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient was experiencing an increase in depressive symptoms (tearfulness). The patient's treating vns therapy physician indicated that the patient had stressors at home that may be contributing to the increased depression and that adjustments would be made to the patient's medications to address the issue. A battery life estimate was performed and the results indicated that the patient's device may be near end of service. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378449
« Last Edit: February 25, 2017, 02:13:26 AM by dennis100 » Logged
dennis100
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« Reply #40 on: May 24, 2011, 12:47:01 AM »

Event Date 05/01/2009
Event Type Malfunction
Event Description
It was reported that a depression patient experienced worsening in depression. Information provided by the patient revealed that her "vns therapy has not been checked in over 1 year and 3 months" and the patient reportedly no longer feels stimulation. The patient changed residencies and was provided a list of medical professionals for follow up but at the moment, the patient has not made an appointment with a psychiatrist. Currently, the relationship of the patient's worsening depression to vns therapy is unknown as 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=1439649
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dennis100
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« Reply #41 on: May 25, 2011, 08:44:45 AM »

Event Date 06/01/2009
Event Type Malfunction
Event Description
It was reported to the manufacturer that the vns patient has been experiencing an increase in depression. It is unknown if the increase is above pre-vns baseline. The relationship between the increase and vns therapy is unknown. It was indicated that the patient's device settings will be modified to increase therapy for improved efficacy. 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=1492058
« Last Edit: February 25, 2017, 02:13:45 AM by dennis100 » Logged
dennis100
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« Reply #42 on: May 25, 2011, 11:43:54 AM »

Event Date 08/04/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt experienced an increase in depression. Currently, the relationship of the increase in depression to vns therapy is unk as good faith attempts to obtain additional info have been unsuccessful to date. Moreover, it is known that both system and normal diagnostics were within normal limits at the time of the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1444500
« Last Edit: February 25, 2017, 02:13:58 AM by dennis100 » Logged
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« Reply #43 on: May 25, 2011, 11:44:24 AM »

Event Date 11/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt will be referred for a generator revision surgery. The pt complained of increased depression. Review of the pt's programming history available in the in-house database revealed that the device is not at end of service, however, this is based off the limited programming and device diagnostic information. The pt has been referred for a surgical consult and good faith attempts to obtain additional information from the pt's treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1444529
« Last Edit: February 25, 2017, 02:14:10 AM by dennis100 » Logged
dennis100
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« Reply #44 on: May 25, 2011, 11:44:56 AM »

Event Date 06/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient was experiencing an increase in depression. The patient's device settings were lowered due to tolerability issues and perception of erratic stimulation. The increase in depression was indicated to be due to loss of therapy from the lowering of device settings. It is unknown if the increase is above pre-vns baseline. There was no trauma or manipulation of the device that may have contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1431957
« Last Edit: February 25, 2017, 02:14:24 AM by dennis100 » Logged
dennis100
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« Reply #45 on: May 25, 2011, 09:42:50 PM »

Event Date 01/01/2009
Event Type Malfunction
Patient Outcome Other;
Event Description
It was reported that the patient's vns has been less effective lately in helping with his recurring depression. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1502885
« Last Edit: February 25, 2017, 02:14:44 AM by dennis100 » Logged
dennis100
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« Reply #46 on: May 25, 2011, 09:43:25 PM »

Event Date 08/01/2009
Event Type Malfunction
Event Description
It was initially reported by the nurse that pt no longer has hoarseness with stimulation and is having increased depression. Diagnostics results showed high lead impedance. Increased depression was back to the pre-vns level. No pt manipulation or trauma was reported. Last good diagnostics were obtained in 2007. No x-rays have been taken or planned. Pt's device has been turned off and is referred to a surgeon for a possible revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1506027
« Last Edit: February 25, 2017, 02:15:10 AM by dennis100 » Logged
dennis100
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« Reply #47 on: May 28, 2011, 02:16:52 AM »

Event Date 04/19/2006
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated the vns therapy system caused a patient's bi-polar disorder to act up. Follow up with the physician confirmed the vns did exacerbate the patient's bi-polar disorder and the device was programmed off; however, good faith attempts to obtain information clarifying if the depression, mania, or both aspects of the disease were exacerbated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1404928
« Last Edit: February 25, 2017, 02:15:25 AM by dennis100 » Logged
dennis100
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« Reply #48 on: May 28, 2011, 02:17:23 AM »

Event Date 05/01/2009
Event Type Malfunction
Event Description
It was reported that a depression patient experienced worsening in depression. Information provided by the patient revealed that her "vns therapy has not been checked in over 1 year and 3 months" and the patient reportedly no longer feels stimulation. The patient changed residencies and was provided a list of medical professionals for follow up but at the moment, the patient has not made an appointment with a psychiatrist. Currently, the relationship of the patient's worsening depression to vns therapy is unknown as 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=1439649
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dennis100
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« Reply #49 on: May 31, 2011, 10:38:03 AM »

Event Date 01/01/2010
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that the patient was placed in an inpatient (b) (6) hospital and put on suicide watch due to increased depression. The relationship of the increase to pre-vns levels is unknown. It is also unknown if there is any relationship between the increased depression and vns, but the patient's treating physician wanted to increase her output current from 1. 0 ma to 1. 25 ma. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1650535
« Last Edit: February 25, 2017, 02:15:48 AM by dennis100 » Logged
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« Reply #50 on: May 31, 2011, 10:38:38 AM »

Event Date 02/01/2010
Event Type Malfunction
Patient Outcome Other;
Event Description
A vns patient called manufacturer and reported that they really needed to have their vns turned up. It was reported that their depression/anxiety has gotten so bad that they have quit their job and have so much panic that they don't leave home much. This has been occurring for the past few months. The depression was reported to have been so bad that she stays in bed 24/7 and can't cope. Follow-up was made with the patient's vns treating physician and the patient has not been into clinic to report the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1638160
« Last Edit: February 25, 2017, 02:16:04 AM by dennis100 » Logged
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« Reply #51 on: May 31, 2011, 10:39:14 AM »

Event Date 12/01/2009
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the pt was no longer feeling stimulation and was also having an increase in depression above pre-vns baseline. The pt's device was last checked in (b) (6) of 2009 and she is not currently seeing a physician who can check her vns as she recently moved. There have been no recent changes in the pt's lifestyle or medications, per reporter. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637148
« Last Edit: February 25, 2017, 02:16:23 AM by dennis100 » Logged
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« Reply #52 on: May 31, 2011, 10:39:52 AM »

Event Date 02/16/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Summary: it was reported that a vns patient experienced pain due to unknown reason. Furthermore, the treating psychiatrist indicated the patient was likely experiencing pain due to short circuit as the physician had received a safety alert letter regarding the issue. A review of the patient's programming history revealed the patient's dc dc code at implant was 1 and impedance was ok, but no additional diagnostics were available. Additional information was received through a company representative indicating the patient was seen by a vascular surgeon as the word vns was misinterpreted and confused for varicose veins. The vascular surgeon was not familiar with vns, but stated the patient was experiencing an increase in depression. At the moment it is unknown if the patient's depression has increased as good faith attempts to obtain additional information with the treating psychiatrist have been unsuccessful to date. Furthermore, no device anomalies are suspected at the time as there is not enough information to confirm the event of short circuit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1635355
« Last Edit: February 25, 2017, 02:16:36 AM by dennis100 » Logged
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« Reply #53 on: June 01, 2011, 11:28:57 AM »

Event Date 04/29/2010
Event Type Malfunction
Event Description
Reporter indicated a vns pt was having increased depression. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1712353
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dennis100
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« Reply #54 on: June 03, 2011, 02:00:18 PM »

Event Date 01/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the patient that she was having an increase in depressive symptoms. She indicated that she was now in the hospital. She stated she had not had her vns system checked since 2006. A search was performed in the manufacturer's programming history database and a battery life estimation resulted in approximately 6. 05 years remaining until eri=yes, which is likely if the patient has not been since 2006. The patient was last seen on (b)(6)2006. Last diagnostics were performed on (b)(6)2006, which were within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828529
« Last Edit: February 25, 2017, 02:16:53 AM by dennis100 » Logged
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« Reply #55 on: June 03, 2011, 02:01:22 PM »

Event Date 04/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt was experiencing an increase in depressive symptoms since (b) (6) 2010. On that day, the pt's vns settings were increased to 0. 5 ma from 0. 25 ma and the pt was started on trazodone. The pt's vns has since been turned off and the pt was taken off trazodone. The reporter believes the problem is most likely due to the medication addition, but decided to turn the vns off and try to turn it back on when the pt's mood improves. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1678644
« Last Edit: February 25, 2017, 02:17:07 AM by dennis100 » Logged
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« Reply #56 on: June 03, 2011, 02:01:53 PM »

Event Date 03/18/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was in the emergency room. The pt had recently been reimplanted with another vns system and since that time it was reported that it hasn't really worked for him. The pt was having an increase in depression and suicide ideation and was hospitalized. They have since been discharged. It was felt that the events may be related to their stimulation. The pt has a history of suicide ideation pre-vns implant. It is unk if the pt's depression is over their pre-vns rate as their treating physician does not know their history pre-vns implantation, but felt it was an increase over their usual. The event did not occur after a medication change or programming change. No diagnostics have been performed at this time to check device function and will be performed when the pt returns to clinic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1678648
« Last Edit: February 25, 2017, 02:17:20 AM by dennis100 » Logged
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« Reply #57 on: June 03, 2011, 02:02:23 PM »

Event Date 04/01/2010
Event Type Injury
Patient Outcome Hospitalization;
Event Description
It was reported to the mfr that the vns pt has been hospitalized due to worsening depression. It is unk if the increase is above pre-vns baseline level. The relationship between the increase and vns therapy is unk at this time. It was indicated that the pt needs electroconvulsive therapy. Good faith attempts to obtain additional info regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1678895
« Last Edit: February 25, 2017, 02:17:33 AM by dennis100 » Logged
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« Reply #58 on: June 03, 2011, 02:03:27 PM »

Event Date 01/01/2010
Event Type Malfunction
Event Description
It was initially reported by the pt that her depression was worse than before she got vns. The pt indicated that she was seen shortly after her implant and hasn't seen any psychiatrist or other physician since (b)(6) 2009. Her prescribing physician confirmed that the pt was seen shortly after implant ((b)(6) 2009) and had not returned since. The pt was believed to be continuing to have depression, not necessarily an increase in depression. There were no details available about her device settings or diagnostics. The pt was noted to have been 5 yrs with no lab work and was last prescribed some medications for her depression. The pt also has missed her last two appointments. No further details were known at this time since the pt has yet to follow up with them on her depression. A search performed in the mfr's programming history database showed last diagnostics to be within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1740248
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« Reply #59 on: June 03, 2011, 02:04:07 PM »

Event Date 07/28/2010
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Initial reporter indicated that they had a pt who was admitted to the hospital for increased depression. It was reported that their depression was likely over their pre vns rate, but relationship to their vns is unk. No diagnostics were performed. The pt had her device temporarily deactivated in order to received ect treatment, which she has previously responded to. It is unk if the pt had any medication change or life event prior to the onset of their increased depression. Good faith attempts thus far have been unsuccessful attainting any further details.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822469
« Last Edit: February 25, 2017, 02:17:51 AM by dennis100 » Logged
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