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dennis100
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« on: May 18, 2011, 12:58:10 PM »

Event Date 10/01/2007
Event Type Malfunction
Event Description
Reporter indicated that a vns pt's generator is not able to communicate due to eos, but the pt still experiences painful stimulation at the neck with magnet activations. The physician suspects that something may be wrong with the lead as the pt falls quite often. The treating physician has recommended that the lead be replaced prophylactically with the generator, because if it is discovered that there is an issue with the lead, then a 102r generator will be wasted due to compatibility with the new lead. The pt is currently scheduled for surgical consult.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=948668

« Last Edit: May 31, 2011, 10:50:16 AM by dennis100 » Logged
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« Reply #1 on: May 18, 2011, 01:04:03 PM »

Event Date 12/06/2007  
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the patient was experiencing neck pain even though the device was turned off. Further follow up with the physician revealed that the cause of the event is unknown; however, it was revealed that it could be due to "tension on the wires. " evaluation of the x-rays revealed that there was a possible kink at the strain loop site. Follow up also revealed that revision surgery is being considered for the patient.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=998830
« Last Edit: October 03, 2015, 07:15:53 AM by dennis100 » Logged
dennis100
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« Reply #2 on: May 18, 2011, 01:04:31 PM »

Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention; .
Event Description
Reporter indicated that a pt would have the vns generator and lead replaced due to painful stimulation at the electrode site. Follow up with the physician revealed that there had been no trauma and that the vns settings had been decreased to a tolerable level. It was reported that although the pain is believed to be related to vns stimulation, the generator has not been set to 0ma to determine if the pain stops without stimulation. X-rays were reviewed by mfr and no anomalies or causes for the event were identified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=998869
« Last Edit: October 03, 2015, 07:16:07 AM by dennis100 » Logged
dennis100
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« Reply #3 on: May 18, 2011, 01:04:57 PM »

Event Date 02/13/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that a pt underwent surgery during which the vns generator and lead were replaced. It was later reported that the devices were replaced due to painful stimulation at the neck. It was reported that prior to surgery, the output current had been reduced in an attempt to alleviate the pain. It was also reported that the cause of the painful stimulation was unk, but the event resolved following surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1021159
« Last Edit: October 03, 2015, 07:16:23 AM by dennis100 » Logged
dennis100
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« Reply #4 on: May 18, 2011, 01:05:32 PM »

Event Date 01/08/2008
Event Type Injury
Patient Outcome Other;
Event Description
Rptr indicated a vns pt was experiencing intolerable painful neck stimulation and increased seizures. The seizure level is at pre-vns baseline levels. X-rays reviewed by the mfr did not identify any obvious lead discontinuities. A surgery consult has occurred but no surgery date has been set.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009722
« Last Edit: October 03, 2015, 07:16:39 AM by dennis100 » Logged
dennis100
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« Reply #5 on: May 19, 2011, 02:25:54 AM »

Event Date 05/02/2008
Event Type Malfunction
Event Description
Reporter indicated a vns pt has "a possible lead issue". The pt is also experiencing neck pain with stimulation. The pt underwent vns therapy system replacement surgery. The explanted products have been returned to the manufacturer and are pending analysis. 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=1054861
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dennis100
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« Reply #6 on: May 19, 2011, 02:26:30 AM »

Event Date 09/06/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer that the vns patient underwent surgery to "put more slack in the lead" due to pain at the neck site. Attempts to obtain additional information from the physician are underway. The patient reports that the surgery "helped tremendously and is no longer have pain at the implantation site and the leads are not as visible in the neck. " further follow up with the treating physician revealed that there was no trauma or manipulation of the device reported that could have contributed to the pain. Additionally, the treating physician stated that recent diagnostic tests have revealed that the device is functioning within normal limits, eos = no.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047204
« Last Edit: October 03, 2015, 07:16:57 AM by dennis100 » Logged
dennis100
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« Reply #7 on: May 19, 2011, 02:27:04 AM »

Event Date 04/16/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Rptr indicated that vns pt underwent prophylactic generator replacement due to pain in the left shoulder and neck area. The explanted generator has been rec'd and is currently awaiting analysis. Good faith attempts for add'l info have been unsuccessful to date

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045372
« Last Edit: October 03, 2015, 07:17:35 AM by dennis100 » Logged
dennis100
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« Reply #8 on: May 19, 2011, 06:16:57 AM »

Event Date 02/27/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns patient was experiencing neck pain with stimulation. Follow up with the treating physician revealed that the neck pain was believed to be due to vns therapy, and that disabling the device resolved the pain. It was additionally reported that no parameter changes were made prior to the onset of the pain. Diagnostics were performed and yielded results within normal limits indicating proper device function. The patient underwent vns therapy system replacement surgery. The explanted products have been returned to the manufacturer and are pending product analysis. 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=1057667
« Last Edit: October 03, 2015, 07:17:55 AM by dennis100 » Logged
dennis100
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« Reply #9 on: May 19, 2011, 06:17:24 AM »

Event Date 03/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that a vns patient was experiencing pain and discomfort at his neck. The patient indicated there were no problems with his vns, and he was receiving efficacy. X-rays were sent to the manufacturer for review. A review of the x-rays revealed that the lead was not routed to form the strain relief at the neck site as recommended per the manufacturer's labeling. No other anomalies were identified. The neurologist indicated revision surgery is likely to relieve the patient's neck pain. It is unclear if the lead will be replaced or the routing of the lead will be corrected. 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=1057673
« Last Edit: October 03, 2015, 07:18:21 AM by dennis100 » Logged
dennis100
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« Reply #10 on: May 19, 2011, 10:04:18 AM »

Event Date 05/19/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that a vns pt was experienced painful stimulation in his neck. At first it was reported that lowering the output current to 1. 0 ma resolved the pain. However, the physician also decided to send the pt for revision surgery due to the painful stimulation. Diagnostic testing showed vns to be functioning properly prior to the surgery. There had been no vns settings changed that preceded the onset of the pain. The explanted generator has been returned to the mfr and is undergoing analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1096488
« Last Edit: October 03, 2015, 07:18:41 AM by dennis100 » Logged
dennis100
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« Reply #11 on: May 19, 2011, 10:04:47 AM »

Event Date 01/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient was experiencing pain in the neck and a popping sound when turning the neck. Patient had lead revision surgery. Attempts for further information and product return are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1091604
« Last Edit: October 03, 2015, 07:19:06 AM by dennis100 » Logged
dennis100
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« Reply #12 on: May 19, 2011, 10:05:19 AM »

Event Date 07/01/2008
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter stated a pt was admitted to the er due to a burning sensation in the neck area and the area was turning red. The pt indicated that it felt as though the device was delivering constant stimulation. According to the pt, the symptoms began after a recent mri. Reporter stated a pt was admitted to the er and subsequent overnight hosp stay due to a burning sensation in the neck area and the area was turning red. The pt indicated that it felt as though the device was delivering constant stimulation. According to the pt, the symptoms began after a recent mri. 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=1084885
« Last Edit: October 03, 2015, 07:19:18 AM by dennis100 » Logged
dennis100
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« Reply #13 on: May 19, 2011, 10:06:07 AM »

Event Date 06/13/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt has pain in her neck and the lead seems to be moving. The pt is very skinny so lead can be seen protruding out of the patient's neck. Diagnostic test were all normal. The manufacturer reviewed x-rays and no strain relief bend or loop were visualized. Additionally, the negative electrode does not appear to be in vertical alignment with the positive electrode as typically seen. 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=1080752
« Last Edit: October 03, 2015, 07:19:39 AM by dennis100 » Logged
dennis100
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« Reply #14 on: May 19, 2011, 10:06:38 AM »

Event Date 03/24/2008
Event Type Malfunction
Event Description
Reporter indicated a vns patient's generator was explanted end of service. Prior to the battery depletion, the patient experienced erratic and painful stimulation in the neck. The patient elected not to have the device replaced. Prod analysis on the generator revealed no anomalies suggesting a malfunction with the lead. The lead was explanted; therefore, a prod analysis will not be performed. The surgeon did not note a malfunction with the lead during the surgery. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1076767
« Last Edit: October 03, 2015, 07:19:57 AM by dennis100 » Logged
dennis100
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« Reply #15 on: May 19, 2011, 10:07:18 AM »

Event Date 04/29/2008
Event Type Injury
Patient Outcome Disability;
Event Description
It was initially reported that the vns patient was experiencing pain and swelling in the neck, constant hoarseness, and apparent protrusion of the electrodes in the neck that has been occurring since initial implant with a worsening of symptoms over time. There was no report of trauma or manipulation reported. However, the generator is implanted near the armpit, and the patient "pushes" it to relocate the device for comfort. Further follow up with the treating physician revealed that vocal cord paralysis is suspected, however, the patient has not been seen by a surgeon to have the paralysis diagnosed. X-rays were taken to assess the system, and the strain relief bend did not appear per our labeling recommendations, as there was no strain relief bend present, and there was no tie-down located lateral of the anchor tether. The placement of the generator appeared normal. Recent diagnostic tests performed have revealed normal device function. The device remains on at this time and the patient is planning to see a surgeon for further evaluation

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069919
« Last Edit: October 03, 2015, 07:20:17 AM by dennis100 » Logged
dennis100
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« Reply #16 on: May 19, 2011, 10:07:48 AM »

Event Date 04/01/2008
Event Type Malfunction
Patient Outcome Other;
Event Description
It was reported that the vns pt was seen by the physician due to pain in the neck. The physician only changed the on and off time which altered the duty cycle from 25% to 23%. Diagnostics were performed at the office and revealed normal device function. The next time the pt was seen by the physician was approx one half months later, and the pt had experienced an increase in seizure activity, relationship to pre-vns baseline unk. The neck pain had not resolved. There was no intervention taken to help with the seizures or the pain at this office visit. Diagnostics were performed and revealed normal device function. X-rays were taken and sent to mfr for review. There were no obvious anomalies observed on the x-rays that could be contributing to the events. The physician has referred the pt to a surgeon for a consult. Attempts to obtain additional info have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069997
« Last Edit: October 03, 2015, 07:20:34 AM by dennis100 » Logged
dennis100
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« Reply #17 on: May 20, 2011, 02:50:34 AM »

Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported to manufacturer that the patient began experiencing painful stimulation at the neck and an increase in seizure activity, below pre-vns baseline. The patient was seen for follow up due to the recent events, and high lead impedance resulted from a system diagnostics test. No x-rays were taken to assess the continuity of the system. The patient subsequently had revision surgery to replace the problematic lead and replace the generator prophylactically. Further follow up with the explanting facility revealed that the explanted devices were discarded following the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1123852
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dennis100
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« Reply #18 on: May 20, 2011, 02:51:26 AM »

Event Date 11/01/2006
Event Type Malfunction
Event Description
It was reported that system diagnostic testing for a vns pt resulted in high impedance readings. The high impedance issue was discovered after the pt had been playing tennis. The pt also reported feeling neck pain on the left side with device stimulation after a tennis game. X-rays were taken and sent to mfr for review, and assessment of the x-rays revealed a gross lead fracture near the generator and another possible fracture between the negative and positive electrode. The pt's treating physician indicated that the observed lead discontinuities were likely related to stresses from the pt playing tennis. The pt may in the future be scheduled for revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1119852

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dennis100
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« Reply #19 on: May 20, 2011, 02:52:03 AM »

Event Date 02/17/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to mfr that the vns pt began experiencing a sudden onset of painful stimulation in the left neck and an increase in seizure activity. Diagnostics performed following the onset of the reported event revealed normal device function. There were no setting changes made prior to the onset of the events and there was no trauma or manipulation reported. A battery life calculation was performed, which ruled out generator end of service. Additional info was rec'd from the treating physician who stated that the pt is going to be referred to a surgeon for possible exploratory surgery, as programming changes have not resolved the painful stimulation. Attempts to obtain the surgical consult date and the name of the referring surgeon for further follow up have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1104288
« Last Edit: October 03, 2015, 07:20:59 AM by dennis100 » Logged
dennis100
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« Reply #20 on: May 20, 2011, 02:52:36 AM »

Event Date 06/12/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to mfr that the vns pt was experiencing pain in the chest at the generator site and pain in the left neck. The device had been disabled and the pain was constant and not associated with stimulation of the device. The pt subsequently had surgery where the generator was removed and the leads were left in place. The explanted generator has been returned to mfr and analysis is underway. Attempts to obtain additional info from 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=1104290
« Last Edit: October 03, 2015, 07:21:11 AM by dennis100 » Logged
dennis100
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« Reply #21 on: May 20, 2011, 02:53:13 AM »

Event Date 06/01/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was experiencing light cramps in the neck on the left side during vns stimulation. The vns settings were lowered, and the pt was feeling some relief of the symptoms. An additional report was received that the muscle cramps continued to occur and were getting worse. The cramps were still present without vns therapy stimulation. The pt received a botox injection, and the muscle cramps have now resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180486
« Last Edit: October 03, 2015, 07:21:34 AM by dennis100 » Logged
dennis100
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« Reply #22 on: May 20, 2011, 02:53:57 AM »

Event Date 08/01/2008
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial reporter indicated that the patient had been explanted for pain in the chest and neck area with vns therapy. Good faith attempts are being made for additional details surrounding the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1181594
« Last Edit: October 03, 2015, 07:21:53 AM by dennis100 » Logged
dennis100
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« Reply #23 on: May 20, 2011, 02:54:52 AM »

Event Date 08/22/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient has been experiencing pain in the neck at the electrode site. Exploratory surgery was performed and the surgeon repositioned the patient's lead. Good faith attempts to obtain additional information regarding this event have been successful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1169943
« Last Edit: October 03, 2015, 07:22:11 AM by dennis100 » Logged
dennis100
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« Reply #24 on: May 20, 2011, 02:55:34 AM »

Event Date 08/13/2008
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that they had a vns patient that was referred to them for pain in the left neck and ear during stimulation. The patient has had this pain since implant. The most recent vns diagnostic test results were reported to be "normal. " setting changes were made for neck muscle contractions with stimulation that resolved but, the patient continued to have the pain with stimulation. It has been decided the patient will have exploratory neck surgery to assess the electrode placement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1169950
« Last Edit: October 03, 2015, 07:22:37 AM by dennis100 » Logged
dennis100
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« Reply #25 on: May 23, 2011, 01:42:46 AM »

Event Date 11/19/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt's vns generator and lead were explanted due to infection. The pt presented with dehiscence and serous drainage at the generator incision site. The pt also had pain and erythema at the neck incision site. During the explant surgery, dark turbid fluid was noted in the generator pocket. The dark drainage fluid was cultured and the causative organism was staphylococcus aureus. The pt was also placed on 500mg ciprofloxacin twice daily by mouth. The pt has fully recovered and will likely be reimplanted with vns in 4-6 months. Reporter indicated the pt had no trauma and did not manipulate the vns. The cause of the infection was the implant surgery per the reporter.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1314355
« Last Edit: October 03, 2015, 07:22:53 AM by dennis100 » Logged
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« Reply #26 on: May 23, 2011, 01:43:57 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a vns patient was experiencing neck pain with stimulation, and diagnostic testing resulted in high lead impedance. Vns was programmed off. Good faith attempts to obtain additional information have been unsuccessful to date. Full revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1315537
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dennis100
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« Reply #27 on: May 23, 2011, 01:44:33 AM »

Event Date 01/12/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported to manufacturer that the vns patient was hospitalized due to painful stimulation in the neck, chest, and arm in addition to a choking sensation with stimulation. The vns device was disabled and the pain was still present, but the dysphagia resolved. Diagnostic tests were performed following the onset of the events, and were reported to be within normal limits. There was no report of trauma, manipulation or other believed cause prior to the onset of the event. As intervention, the physician opted to have the entire device replaced. The explanted lead and generator were returned to manufacturer and analysis underway. Attempts to obtain additional information in regards to the patient status following revision surgery from 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=1310986
« Last Edit: October 03, 2015, 07:23:13 AM by dennis100 » Logged
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« Reply #28 on: May 23, 2011, 01:45:04 AM »

Event Date 01/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a pt with a mass on her neck (near electrode site) would undergo electrocautery to have it removed. Good faith attempts to obtain additional info from the pt's treating physician such as cause of the mass and relationship to the device have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1309904
« Last Edit: October 03, 2015, 07:23:42 AM by dennis100 » Logged
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« Reply #29 on: May 23, 2011, 01:45:39 AM »

Event Date 01/14/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that following lead revision surgery, a vns patient began experiencing neck pain when turning her neck from the left to right and upon tilting her chin back. During the surgery, the lead has been dropped on the floor. The surgeon soaked the lead in betadine and rinsed it off prior to implanting the lead in the patient. The vns device had not been programmed on after the surgery. There was some redness and swelling at the neck incision site which resolved with antibiotics. However, the patient continued to experience neck pain. The surgeon indicated there was no infection at that time. X-rays were sent to the manufacturer for review, and no discontinuities or anomalies were observed. An ultrasound report was received indicating that there was some fluid around the lead and at the generator site. The neurologist believes the ultrasound report suggests that the patient may have an infection. Both the neurologist and surgeon think the pain may be a neuralgia from the surgery, though this has not been confirmed. Both do not think the event is permanent in nature. The patient was treated with another round of antibiotics. Additional information revealed that the patient was evaluated by a different surgeon. Evaluation by that surgeon showed that the patient's pain in her neck has improved and there is currently no infection. Review of the manufacturing records show that the product was sterilized prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1336467
« Last Edit: October 03, 2015, 07:23:57 AM by dennis100 » Logged
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