Pages: 1 ... 20 21 [22]   Go Down
Print
Author Topic: Painful Stimulation  (Read 33879 times)
0 Members and 7 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #630 on: June 08, 2019, 06:50:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8621049
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #631 on: June 09, 2019, 01:51:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/16/2017
Event Type  Injury   
Event Description
It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient's generator and lead were replaced. The explanted products were discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6858790
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #632 on: June 10, 2019, 01:19:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
It was reported by the physician's office that the mother reported the vns generator was making the patient sick and causing discomfort. There was also painful stimulation reported. The patient underwent vns generator replacement surgery. The explanted generator has not been received by the manufacturer to date. Follow up with the company representative revealed that the patient did not show for his follow up appointment. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6984350
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #633 on: June 12, 2019, 03:11:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the surgery was for patient comfort. There were no causal or contributing factors that preceded the painful stimulation and the report of erratic stimulation. The reported protrusion was confirmed invalid and thought to be patient's perception. There was no wires on exam like reported. Patient's settings were provided but diagnostics were not. The patient underwent generator replacement surgery. The explanted device was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949677
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #634 on: June 15, 2019, 11:45:19 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's generator and lead would be explanted due to lack of efficacy. The patient was explanted. While following up with the office, the nurse read from the clinic notes that the patient was explanted because they had no clear benefit from the vns, the vns was causing the patient pain in the neck, and the device was turned off. The nurse could not clarify whether the explant was due to patient pain or just for lack of efficacy. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device available for evaluation?, corrected data: the initial report inadvertently omitted that the products were received. Describe event or problem, corrected data: the initial report inadvertently omitted that the products were received.
 
Event Description
It was reported by the physician that the patient's pain in neck was not the reason for explant. The pain reported was painful stimulation for which the patient's vns was disabled in 2010 for patient comfort. The explanted lead and generator were received. Product analysis was completed on the returned lead portion. The electrodes and part of the lead body were not returned so could not be evaluated. Product analysis identified an abraded opening in the lead outer tubing that caused fluid leaks into the outer tubing. However, product analysis found no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the patient's painful stimulation. The lead performed according to functional specifications with no obvious anomalies identified. Product analysis has not been completed on the returned generator, to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned generator. The generator was monitored for 24 hours in a simulated body temperature environment. The generator provided the intended output current for the entirety of the monitoring period. A comprehensive electrical evaluation showed that the device performed according to functional specifications. No anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042545
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #635 on: June 15, 2019, 11:46:46 PM »

Model Number 302-20
Device Problems Detachment of Device or device Component; Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was complaining of sternal pain with stimulation. However, the vns settings were lowered in steps and eventually disabled with no relief. The vns was programmed back on. The patient was referred for prophylactic vns generator replacement. Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest. Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine. Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted. The patient was then referred for full vns replacement surgery per the clinic notes. The patient underwent only vns generator replacement surgery. The explanted generator was received by the manufacturer and is pending product analysis. It was later reported that the patient was still experiencing pain after the vns generator replacement surgery. The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again. The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck. It was noted that the incision from the generator replacement surgery was well healed. There was no indication of damage on the lead during the vns generator replacement surgery. However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain. No additional relevant information has been received to date.
 
Event Description
Product analysis was completed on the explanted vns generator. Proper functionality of the vns generator was confirmed in the product analysis, or pa, lab. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No variations in the output signal were observed and the generator provided the expected level of output current. The generator performed according to functional specifications. The generator communicated normally and no eri flag was set "as received. " there were no abnormal performance or other adverse conditions found with the generator.
 
Event Description
The explanted lead was received by the manufacturer, indicating that the patient underwent lead replacement surgery, and is pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7030468
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #636 on: June 17, 2019, 04:32:58 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2002
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's device was disabled due to painful stimulation in the left side of neck face and left arm. Since generator replacement, the patient also had pain due to position of device. Diagnostics of the device indicated normal device function and x-rays were taken. The patient therefore requested for device explant and the device was explanted. The device history records were reviewed and the records indicate that both the generator and lead passed all tests and inspections prior to shipment. The explanted devices were not received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7143656
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #637 on: Today at 01:09:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The surgeon reported that the patient was having pain at the implant site. The surgeon stated that everything looked good and that the generator was sitting well in the pocket, and that the wires seem to be intact and correctly located. The patient felt the pain at the electrode site during stimulation and described it as a shocking sensation during magnet stimulation. The doctor believed the patient was doing well and there were no issues with the generator or lead. Diagnostics were within normal limits and the settings were felt not to be contributory to the patient's pain, but the patient was complaining of pain at the generator site. The patient has been referred for surgery. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
Surgery has been completed for this patient's generator replacement. The product has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
Additional information was received that the explanted product is held for 2 years and 3 months by risk management at the explant facility before the product will be returned to the manufacturer. The product has not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7154501
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #638 on: Today at 01:10:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient's mother reported that a patient received stronger stimulation with a magnet swipe. The magnet stimulation reportedly made the patient's seizure worse. No additional relevant information has been received to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not include known medical intervention describe event or problem, corrected data: initial report inadvertently did not include known medical intervention and full list of patient events event problem codes, corrected data: initial report inadvertently did not include full list of patient events. Report source, corrected data: initial report inadvertently did not include consumer. (b)(4).
 
Event Description
It was reported that the patient swiped her magnet again after a dosing appointment where her settings were increased, and she experienced a head tilt to the left, a cold sensation, shaking, painful stimulation, nausea, and pallor with magnet stimulation. This reportedly occurred a few more times, but each time was less intense; however, these events made the patient afraid to use her vns magnet. A company representative and the physician met with the patient and her mother. During the clinic visit, the patient's magnet pulse width setting was reduced from 500 to 250 microseconds. The patient was then able to tolerate stimulation, and the events resolved. Diagnostics were within the normal limits. Use of the magnet had made the patient anxious since she reportedly did not expect to feel stimulation as strongly as she did following the initial settings increase. The physician believed that the reported events the patient's anxiety contributed to the adverse events she experienced with magnet stimulation. Stress was also a trigger for the patient, so the physician believed that the combination of original settings and the patient's anxiety also contributed to the change in seizure intensity. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7122957
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #639 on: Today at 01:11:36 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 10/24/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that low impedance was observed on a patient's vns. A manufacturer representative followed up with the patient about a month later and ran system diagnostic tests. Low impedance was still seen. The patient reportedly denied having any recent injuries or trauma that could have damaged the lead. The physician increased the patient's settings where she reportedly felt a noticeable difference. She also had voice alteration at the higher settings. This indicated some stimulation was still being delivered to the vagus nerve despite the low impedance. A review of the device history record indicated the lead had passed all quality inspections prior to being release for distribution. No surgical intervention has occurred and no further relevant information has been received to date.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: initial report inadvertently did not check adverse event. (b)(4).
 
Event Description
Further information was received from the patient's physician that there was no indication of any trauma or manipulation that might have occurred which could have led to low impedance. When the patient was seen on the day low impedance was first seen, the patient reportedly had discomfort in her throat with stimulation. The patient was reportedly seen at a later date. The system diagnostic test run on this day showed an impedance value within normal limits. There was no data available in the programming history for review and no additional data has been reviewed to date. No further relevant information has been received to date and no surgical intervention has occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7138842
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #640 on: Today at 01:12:44 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 11/23/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient's device was causing him discomfort. High lead impedance was observed on the patient's device. The patient also reportedly had an external skin wound that may have been caused by the vns. The patient's device was programmed off in response. X-rays were performed and reviewed by the physician and reportedly did not identify a lead break or other abnormality. A company representative reported that the pain may be a result of stimulation. The physician suspected that the patient's wound had become infected. At a subsequent visit, the patient's wound had improved significantly since the device was disabled. The company representative confirmed this via assessment of updated pictures of the wound. The patient was given antibiotics. Lateral neck x-rays of the patient's device were reviewed by the manufacturer. Only a small portion of the lead was visible in the images, and the generator was not visible in the x-ray images provided. The lead was observed in the neck. The strain relief bend was present, but a strain relief loop did not appear to be completed. Two tie-downs appeared to be securing the lead past the strain relief bend. No sharp angles or discontinuities were observed in the images. Ap neck and chest x-rays and lateral chest x-rays were later reviewed by the manufacturer. Due to the angle of the generator in the image, proper lead pin insertion could not be assessed. The filter feedthru wires appeared intact. The lead was observed in the neck, and the electrodes appeared to be placed per labeling. The strain relief bend was present, but a strain relief loop did not appear to be completed. No sharp angles or discontinuities were observed in the visible portion of the lead. A portion of the lead was routed behind the generator and could not be assessed. The cause of the patient¿s high impedance could not be determined with the x-ray images provided. The device history records were reviewed for the lead and generator and revealed that both devices met all sterilization and functional specifications for release prior to distribution. The physician did not believe that patient manipulation of the device caused the external wound and infection. The patient was referred for surgery to resolve the high impedance, but no surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent exploratory surgery. It was determined that fluid was observed in the lead, causing the surgeon to suspect a lead fracture. High impedance was observed on both system and normal mode diagnostic tests. The patient was referred for lead and generator replacement surgery, but no additional surgical intervention has occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7132107
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #641 on: Today at 01:13:33 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2015
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had issues with a lead pulling sensation. The patient had a revision surgery to loosen up the lead for more range of motion for the patient and it was noted that the patient had fibrosis around the lead. No additional relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem - corrected information: the information included in describe event or problem on this report should have been included in the initial report as the surgery for the patient was due to the all of the adverse events reported for the patient. Relevant tests/laboratory data - corrected information: the settings and diagnostic data should have been included in the initial report. (b)(4).
 
Event Description
Information should have been included in the initial report that the patient also had painful stimulation and muscle spasms in the neck at the electrode site. The spasms in the patient's neck subsided when the vns magnet was placed over the generator to disable it. The patient's settings were adjusted multiple times and the normal and systems diagnostics were stated to be ok. The painful stimulation and muscle spasms were stated to not have resolved after the surgery to reposition the lead indicating that the surgery could have been to help alleviate those adverse events as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7155729
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #642 on: Today at 01:14:21 AM »

Model Number MODEL 3000
Device Problems Energy Output To Patient Tissue Incorrect; Improper Device Output
Event Date 11/08/2017
Event Type  Malfunction   
Manufacturer Narrative
Software version 1. 0.
 
Event Description
It was reported that the patient was experiencing painful stimulation that occurred when the magnet was swiped. The patient only started experiencing this pain since the most recent adjustment, made with the m3000 programmer. The patient was told to stop using the magnet, until their settings could be adjusted by the doctor. The patient was seen 3 weeks later to reprogram their generator using an older programming system. The magnet current was reduced to help with tolerability. System diagnostics were run and were within normal limits. The patient felt much better about the settings after this appointment. These events have been determined to be due to software error in the m3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators. These incorrect calculations along with a combination of programmed settings, magnet swipes, and autostimulation may lead to a period of continuous current ramping for part or all of an entire therapy burst. During this ramping, the current can exceed programmed values. This is likely the cause of the patient's reported painful stimulation. To resolve this issue, the patient's settings were reprogrammed to avoid this problem. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7133752
Logged
Pages: 1 ... 20 21 [22]   Go Up
Print
Jump to: