Pages: 1 [2] 3 4 ... 39   Go Down
Print
Author Topic: Neck  (Read 252633 times)
0 Members and 6 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #30 on: May 23, 2011, 05:45:41 AM »

Event Date 04/01/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that they were experiencing numbness and pain in the neck. Later information was received that the pt underwent surgery to have the device removed, but the surgeon's office is unsure of why the device was to be removed. All attempts for more information have been unsuccessful, and thus the relationship between events and vns therapy cannot be determined. Attempts to have the products returned to the manufacturer for analysis have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368996
« Last Edit: October 03, 2015, 07:24:18 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #31 on: May 25, 2011, 08:42:37 AM »

Event Date 06/26/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt experienced painful stimulation in the neck area. Good faith attempts to obtain add'l info from the treating neurologist have been unsuccessful at the moment. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476467
« Last Edit: October 03, 2015, 07:24:41 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #32 on: May 25, 2011, 08:43:01 AM »

Event Date 07/22/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt experienced neck pain with stimulation of the device. The magnet was placed over the generator and the pt was evaluated by the neurologist the following day. F/u from the neurologist revealed normal and system diagnostics to be within normal limits. The neurologist reduced the output current and the pt was relieved from neck pain. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476474
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #33 on: May 25, 2011, 08:43:22 AM »

Event Date 03/15/2007
Event Type Malfunction
Event Description
It was reported that a vns patient experienced cough and subsequent muscle spasms in the neck with vns stimulation. X-rays were taken and reviewed at manufacturer no anomalies were observed. The patient's treating physician did witness the muscle spasms and correlated it with stimulation cycles. The patient's device was disabled and both cough and muscle spasms resolved. There are no plans to turn on the device. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478433
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #34 on: May 25, 2011, 08:43:44 AM »

Event Date 09/28/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the patient was experiencing continuous pain in her neck. The event was likely related to stimulation and implantation. No interventions were taken as event was "tolerable" per patient. No further information is available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478431
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #35 on: May 25, 2011, 11:57:18 AM »

Event Date 06/05/2009
Event Type Malfunction
Event Description
It was reported that a vns patient experienced an increase in seizures along with ear, neck, and jaw pain that were related to stimulation. Information from the treating neurologist indicated the increase in seizures was approximately pre-vns baseline or more and the seizure amount would vary. Diagnostics performed on the patient indicated the device to be working within normal limits. The neurologist decreased the output current which resolved the pain events, but started the seizures after decreasing the parameters. Further interventions are to monitor the patient and check the diagnostics.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1486451
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #36 on: May 25, 2011, 11:57:42 AM »

Event Date 09/22/2008
Event Type Malfunction
Event Description
It was reported that a vns pt was experiencing events or erratic/painful stimulation in the neck. Device diagnostics were performed and the results confirmed that therapeutic stimulation was being delivered, though at high impedance levels. The pt's treating vns therapy physician indicated that he felt that these events were related to the near end of service of the pt's device, though the results of diagnostic testing and a battery life estimate indicated otherwise. Follow up with the physician revealed that the pt's symptoms resolved following generator replacement. Good faith attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1470566
« Last Edit: October 03, 2015, 07:25:06 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #37 on: May 25, 2011, 11:58:12 AM »

Event Date 04/20/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported initially that the vns patient was seen by a surgeon to possibly have the vns device removed, due to an unknown reason. Further follow up with the surgeon's office revealed that surgery is not planned, and they had referred the patient back to the neurologist to possibly have the device disabled. Despite good faith attempts made at the time to obtain additional information regarding the reason the device was to be disabled, no additional information had been received. It was later reported that the patient was scheduled for surgery to have the device removed as the patient was experiencing severe neck and chest pain where the vns device was located. Further follow up with the neurologist's office revealed that the pain was constant and there were no causal or contributory programmed setting changes, trauma, or manipulation reported to have occurred prior to the onset of the pain. It was noted that the patient had complained for months of excessive pain. Surgery occurred where it is known that the generator was explanted, which has been returned to manufacturer and analysis is underway. Despite good faith attempts with the surgeon to obtain whether the lead was explanted, no additional information has been received. There are no specific diagnostic test results available; however, the neurologist noted that the device was working properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1445400
« Last Edit: October 03, 2015, 07:25:31 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #38 on: May 25, 2011, 11:58:37 AM »

Event Date 07/28/2009
Event Type Malfunction
Event Description
It was reported that a patient experienced pain and would grab the electrode and generator site every time the device activated stimulation. Further information was received from the medical professional stating that the patient's dc dc code dropped from 2 to 0 on system diagnostics. Additionally, the patient experienced an increase in seizures below pre-vns baseline which have not resolved by an increase in settings like they have done in the past. Based on clinical symptoms and the diagnostic history of the patient's device, the issue is possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1491972
« Last Edit: October 03, 2015, 07:25:45 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #39 on: May 25, 2011, 09:48:46 PM »

Event Date 01/01/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt had their device removed due to pain in the chest and neck that was believed to be caused by the device. All attempts for further info have been unsuccessful to date. Due to procedures at the hospital where the pt had the device removed, the device will not be returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478063
« Last Edit: October 03, 2015, 07:26:04 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #40 on: May 25, 2011, 09:49:24 PM »

Event Date 07/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the vns pt had surgery where the generator was replaced due to an unk reason. Further follow up with the physician revealed that the pt was experiencing a sudden onset of painful stimulation in the neck and disabled the device. The painful stimulation resolved, however, the pt subsequently had a 50% increase in seizure activity, and therefore, the physician referred the pt to a surgeon. There was no report of any pt trauma. There was also no causal or contributory programming changes, medication changes, or other eternal factors that preceded the onset of the painful stimulation. Device diagnostics provided by the physician, indicate normal device function. During surgery, the generator was replaced and the neck incision was opened to examine the lead strain relief. The surgeon excised some adhesions that had formed around the lead boy and the tie-downs used to secure the lead strain relief. The surgeon also "loosened" the lead strain relief. The pt has been seen for follow-up with the treating physician since surgeon occurred and the device has been programmed back to therapeutic levels and the pt is no longer experiencing painful stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1481597
« Last Edit: October 03, 2015, 07:26:27 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #41 on: May 25, 2011, 09:49:58 PM »

Event Date 08/25/2009
Event Type Malfunction
Event Description
It was reported that the patient could feel constant vibration in her neck where the lead is starting on (b) (6) 2009 and felt there was something wrong with the lead. When the patient put the magnet over her device to stop stimulation, the vibration stopped. The patient secured the magnet over her device to stop stimulation. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1507311
« Last Edit: October 03, 2015, 07:26:47 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #42 on: May 28, 2011, 02:58:13 AM »

Event Date 03/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns depression pt was experiencing left arm, left shoulder, left neck and jaw pain with stimulation of the device. The pt was no longer being followed by the psychiatrist, and was referred to a neurologist to assess the painful stimulation. Further follow up with the neurologist who evaluated the pt, revealed that numerous settings were tried, diagnostics were performed to assess the impedance and battery life, in addition to chest and neck x-rays, and multiple neurological tests, and all came back negative per the neurologist. The neurologist subsequently disabled the vns device and the pain resolved. System diagnostic testing performed prior to disabling the device revealed normal device function. Add'l info was received that surgery was planned to have the device explanted. Surgery subsequently occurred and good faith attempts to obtain the explanted devices have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1518834
« Last Edit: October 03, 2015, 07:27:05 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #43 on: May 28, 2011, 02:58:44 AM »

Event Date 01/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns patient was referred to a surgeon to have the vns device removed due to the patient experiencing painful stimulation in the neck. The physician believed that there was a problem with the device, which was causing the painful stimulation, however, the physician did not perform diagnostic testing on the patients device following the onset of the painful stimulation. The patient subsequently had surgery, where the lead and generator were explanted. Prior to explanting the device, the surgeon performed a system diagnostic test, which revealed normal device function. Therefore, with normal diagnostic test results performed following the onset of the painful stimulation, the physician's suspicion of a device deficiency has been confirmed invalid. The explanted lead and generator have been returned to manufacturer where analysis is underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1514057
« Last Edit: October 03, 2015, 07:27:24 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #44 on: May 28, 2011, 02:59:21 AM »

Event Date 09/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient's electrodes moved and has been experiencing discomfort in the neck region. It is unknown at this time how the migration condition was detected. The patient is scheduled for a full revision of the device for the reported event. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1491033
« Last Edit: October 03, 2015, 07:27:39 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #45 on: May 28, 2011, 03:00:18 AM »

Event Date 10/09/2009
Event Type Injury
Event Description
Reporter indicated a vns pt was experiencing painful stimulation in the neck. The vns was disabled as an intervention. The pt was in an accident in 2009 and has experienced the painful stimulation since that time. X-rays were reviewed by the mfr which did not visualize any anomalies, however; no views of the electrode area in the neck were provided. Attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1549472
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #46 on: May 28, 2011, 03:00:58 AM »

Event Date 11/10/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was at risk of having his vns lead protruding due to lack of slack on the implanted lead, as the pt's body is growing. A neurosurgeon evaluated the pt and stated that the strain relief loop in the neck is being pulled as the pt grows. The surgeon plans to have the battery replaced soon, and would like to avoid changing the lead as the device is within normal limits (no specifics given). Additional info was received from the surgeon's office indicating the lead is not protruding, and the surgeon believes the event of lead pulling is related to the pt's normal growth. Further info was received through clinic notes dated 2009 indicating the pt was experiencing pain on the left side of the neck, and indicated the pt will pick at the lead and would project through the skin superficially. Another clinic note from three months later, indicated that at the moment there were no plans to replace the pt's lead, but exploratory surgery was scheduled in which the generator would be replaced prophylactically as the pt's mother wants the generator replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1549477
« Last Edit: October 03, 2015, 07:27:56 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #47 on: May 28, 2011, 03:01:28 AM »

Event Date 07/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure suspected.

Event Description
Reporter indicated that during a generator replacement surgery, it was noted that portions of the patient's neck appeared to be stimulated. Examination of the lead by the surgeon found that there was a bubble, and abrasion in the lead insulation. The surgeon suspected that the issue the patient was experiencing was likely due to current being leaked to the tissues surrounding the vagus nerve, instead of only the vagus nerve. The surgeon proceeded to replace both the generator and the lead. Attempts to have the explanted lead returned for analysis were unsuccessful as the product was discarded.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1551281
« Last Edit: October 03, 2015, 07:28:17 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #48 on: May 28, 2011, 03:03:59 AM »

Event Date 10/22/2009
Event Type Malfunction
Event Description
Initial rptr indicated that the pt was in clinic with severe pain in their neck area. The pt had been reporting shortness of breath and painful stimulation that had occurred sometime in the last week. The pt had not had any trauma or injury to the area. The pt reported that their stimulation feels much stronger now than it previously had, although no settings changes had been made. X-rays were reviewed at the mfr. In the ap view, an acute angle was observed in the lead body near one of the tie-downs. It cannot be determined if this acute angle is contributing to the dcdc = 0. A lead discontinuity cannot be ruled out. No other obvious anomalies were observed in the portions of the lead visualized that could be contributing to the reported dcdc = 0 results. At this time, no surgical plans have been made for the pt's vns. Their vns was programmed off on (b) (6) 2009.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1547258
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #49 on: May 28, 2011, 03:04:35 AM »

Event Date 10/01/2009
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553673
« Last Edit: October 03, 2015, 07:28:37 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #50 on: May 31, 2011, 10:51:00 AM »

Event Date 12/14/2009
Event Type Malfunction
Event Description
It was reported to the mfr that the vns pt has been experiencing painful stimulation in the neck area erratically due to unk reason. Info from the treating neurologist revealed the pt had been doing well since implant in (b) (6) 2002. Furthermore, there were no reports of pt trauma or manipulation that could have contributed to the reported event. Moreover, both system and normal mode diagnostics were performed at the time of the event and resulted within normal limits and it was noticed the dcdc converter code was 0. The physician was notified regarding the possibility of a short circuit condition in the pt's lead. No add'l info has been rec'd regarding last known good diagnostics. The pt has been scheduled for full revision surgery. X-rays to evaluate the integrity of the device have not been taken. If present, an intermittent short-circuit could have potentially contributed to the pt's erratic painful stimulation event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1583750
« Last Edit: October 03, 2015, 07:28:59 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #51 on: May 31, 2011, 10:51:32 AM »

Event Date 06/30/2009
Event Type Malfunction
Event Description
Neurology reported their pt was complaining of pain in the left neck area that seemed to be an electrical type of buzz. The pt reported that it was a near daily occurrence lasting a brief number of seconds. If the pt pushed up on the soft tissue under her left mandible she could decrease the symptoms. The pt was also having an aura- like symptoms around the same time as her pain events. Diagnostics were performed and confirmed proper device function (systems: ok/ok/2/no; normal mode: ok/ok/3/no). It was planned to send the pt for revision since they had been implanted approx 6 years and for pt comfort related to their pain events. The pt's surgeon was concerned there was "some type of malfunction. " neurology confirmed device function and device to be "in working order. " the pt had full revision surgery and the explanted products are at the mfr pending completion of product analysis. The return product form documented the pt had a lead break. X-rays were reviewed prior to surgery that showed no device anomalies in the images available, though the presence of the pt's previous lead and surgical staples was identified. The x-rays confirm the presence of an adequate strain relief bend and the absence of a strain relief loop. Two tie-downs appeared to have been utilized, though both were used to secure the strain relief bend in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1583752
« Last Edit: October 03, 2015, 07:29:13 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #52 on: May 31, 2011, 10:52:02 AM »

Event Date 11/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the nurse that the pt is complaining about pain in his neck and collar bone area during stimulation. Diagnostics was done on the pt and it showed everything working within normal limits (ok, ok 1, no). The treating physician reduced the output current from 2 ma to 1 ma and signal off time from 5 min off to 1. 8 min off. X-rays were taken and there was no lead fracture or acute angles found. No anomaly was noticed on the x-rays as stated by the nurse. Additional info received revealed that the pt had a full revision surgery due to neck pain. Implant card stated dcdc code of 0 on normal and system mode diagnostics. It is unk if the dcdc 0 was on the new device or the old one. Good faith attempts to obtain additional info have been unsuccessful. Device has not been returned for analysis as yet but they are on their way.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1618579
« Last Edit: October 03, 2015, 07:29:27 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #53 on: May 31, 2011, 10:53:09 AM »

Event Date 01/28/2010
Event Type Malfunction
Event Description
It was reported that a pt was experiencing neck pain and that a dcdc of 0 was observed when systems diagnostics were performed. The pt has not had an increase in seizures. X-rays have been ordered but have not been sent to the manufacturer for review. Good faith attempts to obtain add'l info are currently in process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1616300
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #54 on: May 31, 2011, 10:53:39 AM »

Event Date 01/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the mfr that the vns pt has been experiencing discomfort at the device site in the neck. The pt's device has also migrated from the chest to the arm pit area due to recent weight loss. The pt's device has been disabled in 2004 due to an increase in seizure activity (refer to mfr report #1644487-2010-00408). The pt's generator was explanted with no plans for replacement due to the reported irritation and lack of efficacy. The explanted generator has been returned to the mfr for analysis. Product analysis is currently underway. Good faith attempts to obtain add'l info regarding the reported events have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615471
« Last Edit: October 03, 2015, 07:29:41 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #55 on: May 31, 2011, 10:54:21 AM »

Event Date 01/31/2010
Event Type Malfunction
Event Description
It was reported that the pt was seen for a follow up appointment due to sudden neck pain, which the pt felt was related to the vns device. In addition, the pt had been sick over the previous weekend with vomiting, and the neck pain worsened. The pt had secured the magnet over the generator site to temporarily disable stimulation until the appointment. At the follow up appointment, a system diagnostic test was performed which revealed high lead impedance. The pt subsequently had surgery where only the generator was replaced. Further follow up with the surgeon revealed that the high lead impedance resolved when a new generator was connected to the existing lead. Good faith attempts to obtain additional information are underway. The explanted generator has been returned to manufacturer where analysis is underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1634497
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #56 on: May 31, 2011, 10:54:59 AM »

Event Date 03/01/2010
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
It was initially reported to the mfr that the pt was admitted to the er because, the pt was experiencing neck swelling, painful stimulation and dyspnea. The pt was referred to a surgeon and was scheduled for a lead revision surgery due to a suspected lead break. The pt's treating neurologist believes the swelling and dyspnea are related to vns, dyspnea occurs with stimulation and the pt does not have any history of dyspnea pre-vns. The pt's lead body was replaced due to a lead break. It was indicated that there were no casual or contributing factors, or any pt manipulation or trauma that occurred to have contributed to the lead break. Good faith attempts to obtain more info regarding the suspected lead discontinuity have been unsuccessful to date. The explanted lead body has been returned to the mfr and analysis is in process.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675414
« Last Edit: October 03, 2015, 07:29:57 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #57 on: May 31, 2011, 10:55:40 AM »

Event Date 03/13/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the pt would experience an "electrical shock" in her neck with device stimulation. The pt stated she placed her magnet over the device to temporarily inhibit stimulation however this made the pain worse. The physician in the er who saw the pt did not believe this issue was serious and indicated that the pt was making herself more anxious over the stimulation. The pt followed up with her neurologist who programmed her device off. The physician indicated that pain resolved once the device was programmed off. X-rays were taken and sent to the mfr for review and no obvious causes for the pain could be identified. The pt underwent a full revision due to the pain in which the lead was replaced due to a lead fracture and the generator was replaced prophylactically. The lead and generator has been returned to the mfr and product analysis is currently in process. Good faith attempts to obtain additional info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1666447
« Last Edit: October 03, 2015, 07:30:09 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #58 on: June 01, 2011, 11:37:37 AM »

Event Date 04/26/2010
Event Type Malfunction
Event Description
A vns programming physician reported to our consultant that they had a vns patient and after performing a normal mode and system diagnostic test the results indicated: high: limit: dcdc: 7, eos: no. It was additionally reported that the patient has been experiencing pain with stimulation in the neck region that started about 2-3 weeks ago. The pain became worse the last couple of days. The patient had used his magnet and disabled his device and pain went away. No trauma or manipulation to the device was reported. The patient's vns was programmed off. The patient's depression has been increasing since their vns has been programmed off. X-rays were received for review by manufacturer and their generator placement appeared normal and the filter feed-throughs appeared to be intact. The lead connector pin was verified to be fully inserted into the generator connector block. The lead was verified to be intact at the connector pin. Strain relief could not be assessed due to x-ray reviews provided, as views of the neck region were not sent for review. No acute angles or obvious gross lead discontinuities were observed in the visible portion of the lead. A portion of the lead, located behind the generator, could not be assessed. The patient is pending insurance approval to be scheduled for full revision surgery. No surgery date is set at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1711609
« Last Edit: October 03, 2015, 07:30:27 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« Reply #59 on: June 01, 2011, 11:38:55 AM »

Event Date 03/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. 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=1698103
« Last Edit: October 03, 2015, 07:30:40 AM by dennis100 » Logged
Pages: 1 [2] 3 4 ... 39   Go Up
Print
Jump to: