Pages: 1 2 3 [4] 5 6 ... 26   Go Down
Print
Author Topic: Chest Pain  (Read 230466 times)
0 Members and 4 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #90 on: December 17, 2010, 12:16:24 PM »

Event Date 06/30/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
The reporter was recently implanted with a new generator and is experiencing a rapid heart rate of 134 bpm, exhaustion, and slightly elevated blood pressure. It was further reported that the pt is also experiencincing pain in the generator area when the device stimulates. The generator was programmed on to 1. 25ma immediately following the implant. The generator was checked and found to be properly functioning. It was also reported that an attempt to alleviate the pain by adjusting the parameters was done, however, the pt still experienced pain during device stimulation. The pain stops when the gneerator is inactivated using the magnet. Further troubleshooting is currently being done. The cause of the reported event are unknown at this time; this event is currently being investigated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=623815
« Last Edit: February 13, 2015, 12:50:04 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #91 on: December 17, 2010, 12:16:59 PM »

Event Date 08/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient was experiencing sporadic stimulation that sometimes caused chest pain and pain in the neck area. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. Based on known device settings, remaining generator battery life was estimated to be approximately 1. 09 years. Investigation to date has been unable to determine whether the chest pain is cardiac-related as no response has been received to manufacturer's request for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=638687
« Last Edit: February 13, 2015, 12:50:38 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #92 on: December 17, 2010, 12:17:35 PM »

Event Date 11/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient has experienced palpitations and feelings like his heart was `racing' during device stimulation over the past week. Cardiac testing, including an ecg, was normal. Device diagnostic testing was within normal limits, indicating proper device function. The patient was reportedly instructed to temporarily discontinue stimulation with the magnet if the palpitations worsened.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=652998
« Last Edit: February 13, 2015, 12:51:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #93 on: December 18, 2010, 01:28:04 AM »

Event Date 01/25/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that upon initiation of device stilulation, vns pt experienced heart palpitations and shortness of breath with each stimulation cycle. The pt used the magnet to temporarily discontinue stimulation until she was seen by treating physician the following day. Programmed pulse width setting was reduced from 500u to 250u, after which the pt's symptoms resolved. No further action is planned by physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=679113
« Last Edit: February 13, 2015, 12:51:39 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #94 on: December 18, 2010, 01:28:46 AM »

Event Date 12/29/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that during device stimulation cycles, vns patient experienced heart palpitations and a burning sensation underneath the generator with pain to left chest which radiated to his heart. The patient reported the event to his neurologist who programmed the device to off pending evaluation by a cardiologist. The patient denies recurrence of this episode since stimulation was discontinued. Further follow-up revealed that the patient complained of chest pain approximately three months prior and that the pain subsided after device output current setting was reduced from 1. 0ma to 0. 75ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=668903
« Last Edit: February 13, 2015, 12:52:27 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #95 on: December 18, 2010, 01:29:24 AM »

Model Number 101
Event Date 12/07/2005
Event Type Injury
Event Description
Further follow-up revealed that the patient's shortness of breath and pain in the chest resolved when the generator's output current was reduced. The physician believes the events were related to the vns stimulation. The patient was never hospitalized for the shortness of breath. The cause of the reported pain and dyspnea was likely due to intolerable generator parameters.

Event Description
Vns patient has experienced trouble breathing since last 0. 25ma increment increase in device output current setting. The patient reportedly cannot tell whether she only experiences trouble breathing during device stimulation cycles. The patient reportedly went to the hospital emergency room, at which time a cardiac work-up was negative. Report is incomplete because no reponse has been received to manufacturer's request for additional information from treating physician (via fax x1).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=665071
« Last Edit: November 20, 2015, 07:25:50 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #96 on: December 18, 2010, 01:30:06 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt was experiencing 'ache-ness' in the area of the generator about twice per day. Review of x-rays by mfr revealed that the generator was implanted in left chest with lead connector pins fully inserted past the generator block, filter feed-throughs intact and lead wire intact at the connector pin. Only one lead electrode was visible. Strain relief loop and strain relief bend were noted and 2 tie downs were seen. No visible acute angles were observed in the lead. A portion of the lead was not visible as it was behind the generator that could possibly have been a lead discontinuity; however, this could not be confirmed due to the poor quality of the film. Further follow-up revealed that the pt's symptoms have increased, both in intensity and frequency (now between 4-7 times per day). Treating neurologist indicated that the symptoms may be related to the pt's lifting of moderately heavy boxes while at work (between 10-40 pounds), possibly resulting in current leakage due to potential damage to the device. Neurologist plans to perform device diagnostics testing at next office visit. Treating neurologist indicated that it was possible that the pt's pain was cardic-related due to her age and the fact that she was obese, but he also indicated that nothing suggests cardiac right now. Investigation to date has been unable to rule out cardiac involvement as the source of the pt's chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660582
« Last Edit: February 13, 2015, 12:53:58 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #97 on: December 18, 2010, 01:30:44 AM »

Event Date 12/02/2005
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was hospitalized in intensive care unit because her device 'went haywire' and she felt like it was shocking her from the generator site all the way up her neck, through her head, and down her back. The patient reported that the patient was unbearable. While hospitalized, a cardiologist reportedly told the patient that she had a heart problem and that if she experienced a similar incident again, she would die; however, the patient did admit that she was medicated at the time of her discussion with the cardiologist and that she did not remember the entire conversation. It was reported that normal mode stimulation was discontinued while the patient was hospitalized but that magnet mode stimulation remained active. The patient reports that 'her voice was damaged and it was difficult to swallow' since being discharged from the hospital three days later and that she is subsequently not able to swallow her medications. The patient reports that she has not experienced any pain since the normal mode output current was programmed to off and she has not had any seizures. Further follow-up with treating neurologist revealed that the patient has irregular heartbeats and that she will be evaluated at an upcoming appointment to determine what the cause of the cardiac problem is. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. Additionally, device tracking information was not forwarded to manufacturer at the time of initial implant and attempts to obtain it have been unsuccessful to date (via fax x2 to implanting facility).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660381
« Last Edit: February 13, 2015, 12:55:11 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #98 on: December 18, 2010, 02:21:31 AM »

Event Date 06/06/2006
Event Type Death
Patient Outcome Death;
Event Description
The deceased had a history of seizure disorder-grand mal and reportedly had a nerve stimulator placed since 2003 and replaced 2005. Prior to her death, she had complained of the stimulator "moving out of place" and "giving shocks. " the stimulator was last tested feb 2006 and was reportedly "fine. " she was found collapsed at home. Autopsy offered a nerve stimulator attached to a nerve in the upper chest with no other significant findings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=751310
« Last Edit: February 13, 2015, 12:56:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #99 on: December 18, 2010, 06:21:44 AM »

Event Date 12/02/2007
Event Type Malfunction
Event Description
It was reported to mfr that the vns pt was feeling that the "stimulation was shocking her and feels that she is being electrocuted". Additionally, it was reported that the magnet did not work to inhibit stimulation when placed over the generator site. Attempts to obtain add'l info from the treating physician are under way.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971186
« Last Edit: February 13, 2015, 12:56:48 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #100 on: December 18, 2010, 06:22:21 AM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that a vns patient's generator was explanted due to end of service. Follow-up with the treating physician revealed that the patient's device was actually replaced due to pain at the generator site and the physician was "worried about local nerve compression or inflammation. " the pain was reported to be associated with arm movement or physically displacing the stimulator. During generator replacement surgery, neither neuroma nor obvious compression was found. The physician reported that the pain appeared to be of neuropathic origin. The explanted generator was returned to the manufacturer for analysis. No anomalies that could have contributed to the event were noted. The pain has reportedly somewhat improved following generator replacement surgery, but is still present in the left wrist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=866954
« Last Edit: February 13, 2015, 12:57:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #101 on: December 18, 2010, 06:22:58 AM »

Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that pt was experiencing painful stimulation to the left shoulder, left arm, chest and stomach, and in addition, reported feeling a "loose piece of metal in the generator area". During the investigation, it was noted that the pt only had these complaints after she underwent two surgeries for implantation of bilateral prosthetic breast implants due to previous bilateral mastectomies. X-rays reviewed by mfr showed appearance of the connector block not in parallel alignment with the generator. Last known diagnostics indicated proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=967445
« Last Edit: February 13, 2015, 12:57:54 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #102 on: December 18, 2010, 06:23:37 AM »

Model Number PULSE MODEL 102
Event Type No Answer Provided
Event Description
Device placed earlier this year and patient has been experiencing chest and abdominal pain since.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788164
« Last Edit: February 13, 2015, 12:58:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #103 on: December 18, 2010, 06:24:17 AM »

Event Date 01/01/2006
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated a patient passed out due to a shocking sensation from the vns device. The patient subsequently had the vns device explanted. The pateint was implanted for intractable hiccups.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=817994
« Last Edit: February 13, 2015, 12:59:06 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #104 on: December 18, 2010, 06:24:52 AM »

Event Date 12/14/2006
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated the pt experienced midline chest pain and shortness of breath postoperatively. The pt was admitted to the hospital for eval and treatment. Intravenous morphine was administered for her chest pain. She also rec'd heparin and oxygen. The discharge summary indicated the symtpoms could be related to the pt's incisional type pain. The physician feels the chest pain and shortness of breath was related to the vns surgical procedure and not the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842015
« Last Edit: February 13, 2015, 12:59:40 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #105 on: December 18, 2010, 06:25:30 AM »

Event Date 02/01/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient was experiencing severe headaches, heart palpitations, and increased blood pressure since vns therapy system implant surgery. The patient was hospitalized for testing and the physician programmed the pulse generator off. While the device was programmed off, the patient's symptoms subsided. Diagnostics are not available. Explant surgery is likely. Attempts to gain additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=842507
« Last Edit: February 13, 2015, 01:02:35 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #106 on: December 18, 2010, 06:26:08 AM »

Event Date 03/01/2007
Event Type Malfunction
Event Description
Reporter indicated that device was delivering painful stimulation longer and more often than programmed. Events reportedly discontinued after 3 days. Physician performed diagnostic testing and reported all results were within normal ranges. Good faith attempts to gain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950567
« Last Edit: February 13, 2015, 01:03:23 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #107 on: December 18, 2010, 06:26:44 AM »

Event Date 04/01/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient's generator and lead were explanted because the device was "shocking the patient. " implant card received by manufacturer indicated patient was reimplanted with the vns therapy system on the same day as he was explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=855645
« Last Edit: February 13, 2015, 01:04:05 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #108 on: December 18, 2010, 06:27:19 AM »

Event Date 10/01/2006
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient had severe pain during vns stimulation and device was unable to be interrogated. The patient underwent surgery where the vns therapy system was explanted. No records of diagnostic testing and attempts to obtain programming history were unsuccessful. The explanted generator has not been returned for product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=855806
« Last Edit: February 13, 2015, 01:04:46 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #109 on: December 18, 2010, 06:27:56 AM »

Event Date 09/07/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a patient experienced tachycardia and heart palpitations after initial vns implant surgery. The vns device was not activated at that time. Medication was given and the tachycardia and heart palpitations resolved. The patient remains on vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=852424
« Last Edit: February 13, 2015, 01:05:12 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #110 on: December 18, 2010, 06:28:33 AM »

Event Date 06/23/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt was experiencing sharp pain at the vns generator site, even when the device was programmed off. The pt is a poor historian and may not remember any trauma per the reporter. Trauma is suspected, as well as the generator itself possibly causing the pain. The reporter has decided to proceed with a prophylactic generator replacement to see if the pain will resolve. Surgery is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=885280
« Last Edit: February 13, 2015, 01:06:19 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #111 on: December 18, 2010, 09:34:37 AM »

Event Date 10/29/2007
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Initial reporter indicated that, the patient's physician is inserting a "right vns", but no new generator. Additionally, it was reported the surgeon was planning on replacing the lead only and implanting it on the right vagus nerve. The patient was experiencing pain and doctor associated the pain with the lead because, when the device was turned off, the pain resolved. The physician reported that diagnostic results were "great" and x-rays revealed no anomalies. He said that he "programmed off the generator and the pain went away. " he said he "can also lower settings and the pain is less intense. " he said the "patient also has psychiatric issues and that may be contributing to her ability to tolerate it", but "the pain is still bad enough that something has to be done. " he said that the painful stimulation started out of "nowhere" and he "does not know the cause" because of the good diagnostics and x-rays. The patient underwent the lead replacement surgery and the mfr is making good faith attempts for the explanted lead to be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=954402
« Last Edit: February 13, 2015, 01:07:16 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #112 on: December 18, 2010, 12:10:29 PM »

Event Date 07/01/2007
Event Type Injury
Patient Outcome Other;  
Event Description
Initial reporter indicated that the patient was involved in a "takedown" at his job at a correctional center. The patient reportedly came into the office two weeks later and reported that he was walking along the street to the mailbox and developed sudden chest pain, tightness in his throat, pain in his head and passed out. He was seen in the er and had a mri and eeg which yielded normal results. System diagnostics testing performed were within normal limits indicating proper device functioning. The patient reportedly had a second occurrence of sudden chest pain, tightness in the throat, pain in the head and "almost" passed out. The vns was disabled with the magnet and was subsequently programmed off. No events occurred with the vns programmed off. Chest films reviewed by manufacturer yielded no device anomalies. The vns therapy is now programmed back on and at this time the patient has not had any reoccurrence of the events. The patient's treating physician indicated the events are related to the patient's vns therapy stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902898
« Last Edit: February 13, 2015, 01:08:24 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #113 on: December 18, 2010, 12:11:26 PM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that pt is to have her vns therapy system explanted due to chest pain and a lack of efficacy from the device. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=955859
« Last Edit: February 13, 2015, 01:09:06 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #114 on: December 18, 2010, 12:12:20 PM »

Event Date 07/20/2007
Event Type Injury Patient Outcome Other;
Event Description
It was reported to mfr that the vns pt is experiencing a "sensation of heart racing" that occurs only with stimulation on times. The magnet is used to temporarily disable stimulation to help with tolerability. Additionally, it was reported that the vns pt was experiencing intermittent shortness of breath. Medication changes were made to help with the event. In addition, it was reported that the pt experienced tightening in the chest and throat during stimulation on times. Use of the magnet to temporarily disable the device, and medication changes were made to help with this event. The physician believes that these events are possibly related to stimulation of the device. The heart racing event has resolved since the initial report. Review of the available programming history revealed that setting changes were made to decrease the output current following the onset of the reported events. Attempts to obtain add'l info from the physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948583
« Last Edit: February 13, 2015, 01:10:18 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #115 on: December 18, 2010, 12:13:11 PM »

Event Date 04/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated patient was undergoing a full revision procedure due to continued pain he was experiencing. It was reported that this pain was a shocking sensation that occurred in the chest and neck, but was not directly related to stimulation. Good faith attempts to obtain explanted products for analysis will be made once surgery occurs.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=933194
« Last Edit: February 13, 2015, 01:10:51 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #116 on: December 18, 2010, 12:13:57 PM »

Event Date 09/24/2007
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the vns epilepsy patient went to the emergency room complaining of severe chest pain. Further follow up with the treating physician revealed that the chest pain resolved when the device was disabled. The device has been turned back on, but at much lower settings due to tolerability. Device diagnostics were performed following the onset of the event and revealed normal device function. There has been no report of recent trauma, or any other event that could be contributing to the chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=929536
« Last Edit: February 13, 2015, 01:11:35 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #117 on: December 18, 2010, 12:14:40 PM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that vns pt would have the vns device explanted due to painful stimulation near the generator site. It was reporter by the treating neurologist's office that device settings had been changed in attempt to reduce pain; however, the pain persisted. The office also stated that the vns device had been turned off "for awhile". It was also reported that device diagnostics have been within normal limits and there is no report of device malfunction. It is unk if the pt's vns device has been explanted. Attempts to gather add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=926548
« Last Edit: February 13, 2015, 01:12:11 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #118 on: December 18, 2010, 12:15:46 PM »

Event Date 08/01/2007
Event Type Malfunction
Patient Outcome Hospitalization;
Event Description
Reporter indicated the patient, after doing some heavy lifting, began experiencing sharp chest pain with device stimulation. Subsequently, the patient went to the hospital. During hospital visit, a system diagnostics test was performed, and yielded good results. The patient's device was then programmed off. X-rays were taken and viewed by the physician. The physician indicated the x-rays were negative. The patient underwent vns therapy system replacement surgery. The implant and warranty registration card provided by the facility indicated that the patient vns therapy system was reimplanted as it was "non-functioning. " further follow-up with the surgeon's office indicated that the patient underwent a recent surgical procedure at which time he had his vns turned off. When the vns was turned back on the patient was experiencing a "shocking feeling". No other information was available. Good faith attempts are being made to obtain additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=925728
« Last Edit: February 13, 2015, 01:13:02 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #119 on: December 19, 2010, 06:37:45 PM »

Event Date 06/30/2008
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated experiencing an episode of severe chest pain. The hospital performed a cxr and informed the patient that "it looked like it may have been detached. " the patient did not know what was meant by this statement, and was referred the neurologist. The patient also reported experiencing an increase in seizures. The patient's seizure activity level prior to being implanted with vns is unknown. Follow up with the neurologist revealed diagnostic testing was within normal limits and was not at end of service. The pt elected to have the generator replaced. 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=1091623
« Last Edit: February 13, 2015, 01:13:41 AM by dennis100 » Logged
Pages: 1 2 3 [4] 5 6 ... 26   Go Up
Print
Jump to: