Pages: [1]   Go Down
Print
Author Topic: Chest  (Read 315 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« on: March 28, 2019, 07:36:57 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8004870
« Last Edit: May 01, 2019, 01:03:14 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #1 on: March 28, 2019, 07:37:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient presented to the physician's office with the vns chest incision red and "angry" looking, per the physician. It was stated at the time that there was no infection or drainage, but the incision was red and puffy looking. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. Follow up with the physician's office revealed that the wound site did not seem to be manipulated other than potentially by tension pulling at the incision site. It was stated that this was possibly from pulling at the patient's arm or lifting the patient under the shoulders. It was reported that the patient was very hyperactive and may have caused the separation from rough play. It was unclear if this was a report of the incision coming open. Removal of the vns was planned to preclude serious injury. Further follow up with the physician's office revealed that the incision had come open, but did not come completely open. The incision site was reported as infected, but the physician caught it in time and were able to treat the infection with antibiotics. It was reported that there was no surgical intervention, but the patient was admitted to the hospital where iv antibiotics were provided. The patient was then sent home on two weeks of antibiotics. The physician's office reported that they had seen the patient since and the patient was doing well. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7044768
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #2 on: March 28, 2019, 07:38:27 AM »

Model Number 106
Event Date 01/05/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's mother that there was bruising around the incision site after the vns generator and lead were implanted. An additional phone call was later placed by the patient's mother. The patient's mother explained that the patient initially had a decrease in seizures right after surgery, from about 30 seizures/day down to about 5 seizures/day until (b)(6) 2016. On (b)(6) 2016, the patient had approximately 30 seizures, on (b)(6) 2016 the patient had greater than 50 seizures, and on (b)(6) 2016 the patient had nearly back to back seizures. The patient was taken to the er and the patient's following neurologist came down to the er and programmed the patient's vns on. The patient tolerated the stimulations. It was also reported the patient's mother had used the vns magnet to activate the vns several times on (b)(6) 2016 and noted the patient had done ok with the magnet stimulations. However, it was noted that the patient had some blotchiness on her face, neck, and chest but the cause of the blotchiness was unknown. The blotchiness was noted to come and go with seizures, but not all seizures. The dhrs for both the lead and the generator were reviewed and confirmed the devices passed all testing and were sterilized prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received showing the patient was actually hospitalized for 2 weeks, due to the increased seizures, beginning on (b)(6) 2016. It was also noted the vns magnet was used to temporarily disable to the device; however, it is currently unknown why this disablement occurred. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician who stated the bruising, increase in seizures, and blotchiness were not related to vns, and the office has since made titrations with no recurrence of the issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446622
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #3 on: March 28, 2019, 07:39:09 AM »

Model Number 304-20
Device Problems Extrusion; Lead
Event Date 10/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had inflammation and lead extrusion at the neck incision about six weeks after implant surgery. There was no indication of an infection. The physician did not know the cause of the inflammation or lead extrusion since the wound had been healing well after the implant surgery. On (b)(6) 2015, the lead was reinserted into the neck without the nerve and electrodes being touched during the procedure, and the incision was closed. The incision was reported to be healing well after the surgery.
 
Event Description
It was reported that an infection was present at the generator and lead sites on (b)(6) 2015. Infected skin necrosis on the left chest wall was found, and an open wound was visible with drainage. The generator and lead were explanted on (b)(6) 2015. The infection appeared spontaneously and was not attributed to patient manipulation. The physician plans to re-implant the patient with a new vns system in 3 months, because the patient responded well to therapy. The device history records for the generator and lead were reviewed, and both were sterilized prior to distribution. Attempts for additional information were unsuccessful to date.
 
Event Description
The physician believed that the cause of the infection was that the patient developed a seroma at the generator site 4 weeks post-op. Cultures were taken, and the result was staphylococcus aureus with multiple sensitivities (not (b)(6)).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224608
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #4 on: March 28, 2019, 07:39:47 AM »

Model Number 102
Event Date 09/21/2009
Event Type  Injury   
Event Description
It was initially reported that the pt was having "erosion" on her chest from the leads and was scheduled for device removal. It was later indicated that the pt was experiencing an infection and would be on antibiotics for two weeks following explant. It was expected to have her device replaced at that time. Later, the pt was confirmed to have had (b) (6), but no known cause was indicated. There is now no known date of device re-implant. The pt was said to have this infection since implant and it was difficult to get rid of. The device was confirmed to have been sterilized prior to distribution. No further details were made available on the issue.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1641394
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #5 on: March 28, 2019, 07:40:44 AM »

Model Number 106
Event Date 02/24/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient has swelling at the chest incision. The patient was implanted on (b)(6) 2016. The swelling was described as raised and warm to touch. The vns device is not on. There is no neck swelling. Of note, the patient does cpt (chest percussion therapy) vest therapy. He did cpt the 1st day postop and there was some bleeding of the chest incision site, so since then the cpt therapy has been discontinued. Follow-up with the surgeon's office showed that the patient was seen on the 10th. It was determined that the patient had a seroma above the chest incision and antibiotics were prescribed as a precaution for any infection that may develop and the seroma was drained at the appointment. No infection was confirmed but the precautionary medicines were provided. The patient's home was instructed to give the antibiotics. No explant of the device is planned. On (b)(6) 2016, it was reported that the patient's lead wire is poking through the incision.
 
Event Description
Clinic notes received (b)(4) 2016 and dated (b)(6) 2016 states that patient has problems with lead. It was stated it was complicated by a small seroma which was evacuated 2 weeks ago. The patient returns today with a small portion of the vns lead extruding through the skin. This is in the area where the seroma had thinned out the wound. There is no sign of infection or drainage. The surgeon recommends revising the pocket in such a way that his leads will be placed back in the tissue deeper. Due to the patient's mental status, this will have to be done in the or. The patient's surgical intervention has not occurred to date due to the patient being hospitalized for pneumonia and dehydration.
 
Event Description
It was reported on (b)(6) 2016 that the patient was taken to the hospital due to a hemotoma. The surgeon performed surgery that day to clean out the generator site due to the lead being exposed. System diagnostics performed at this surgery showed the device was working within specifications. It was reported on (b)(6) 2016 that the patient underwent a surgery that morning. It was stated that the patient had a hemotoma at the chest incision and the lead wire was still poking through the skin. The surgeon cleaned out the hematoma, covered the area in antibiotic powder and put a wound vac in place that he planned to keep in through the weekend. Per the nurse, the patient thrashed around a lot, picked at his incision site and they felt that was contributing to the problems.
 
Event Description
It was reported on (b)(6) 2016 that the patient is referred for explant as it appears that his body is rejecting the lead/generator. The patient now has an open incision. No confirmation of the explant surgery has occurred to date.
 
Event Description
The generator and the lead were explanted on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529930
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #6 on: April 15, 2019, 01:27:04 AM »

Model Number 303-20
Event Date 12/07/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had significant swelling at the electrode and generator sites. It was initially thought that the patient had an infection, but that was ruled out. The patient then had a nuclear medicine scan, which showed that the patient had lymphatic fluid in the soft tissue surrounding the electrode site and was leaking down to the chest pocket as well. The patient was feeling painful stimulation in the neck, which the physician attributed to the electrode site being irritated and swollen. It was determined that the fluid collection was due to the implant location of the electrodes. The physician performed lead revision surgery on (b)(6) 2016 to replace the lead and position the new electrodes in a different location on the nerve. The physician did not observe any fluid when he was performing the lead revision surgery. The explanted lead was received on (b)(6) 2016. Analysis was approved on (b)(6) 2016. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5851977
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #7 on: May 01, 2019, 01:04:15 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/03/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient was having issues with his new device. He reported pain and swelling on the left side of his neck, shoulder, jaw, and was having muscle spasms on the left side of his neck, he felt a lead pulling sensation across his neck and chest, and he had coughing associated with stimulation. The patient also said that it looks like he has an infection. The physician later reported that diagnostics were run and were within normal limits. She stated she had decreased the output current to attempt to alleviate the issues. The patient was scheduled for a follow-up appointment but did not show up. The physician noted she had referred the patient to a surgeon who is more experienced with vns. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Information was received that after the patient's consult with the surgeon, he was referred for a lead revision. The surgery was scheduled but the patient was initially a no-show. The surgery has been rescheduled but has not been completed to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Lead revision surgery occurred. The explanted device was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6316710
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #8 on: May 10, 2019, 01:50:00 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient underwent a recent vns generator replacement, and it was reported that a possible abscess was observed on the patient¿s neck area close to the lead since the replacement. Additionally, two small openings in the chest wound were reported and the generator can be seen through the wound. The generator was later removed along with most of the lead. The manufacturing records for the lead and generator were reviewed and verified both devices were sterilized prior to distribution. The devices met all specifications for release prior to distribution. No additional, relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566643
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #9 on: May 27, 2019, 11:19:07 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/27/2016
Event Type  Injury   
Event Description
It was reported that the patient underwent explant surgery due to infection. Vns lead wire was prominently protruding outward. Vns generator site on chest was puffy. A review of device history records showed that both the lead and generator were sterilized prior to distribution. High impedance was also observed for the patient's device and is reported in mfr. Report # 1644487-2017-04025.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6661924
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #10 on: June 01, 2019, 03:32:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because analysis will not yield any relevant information to the reported event of infection.
 
Event Description
The patient's caregiver noticed some blood on patients shirt. They looked under his shirt and observed swelling and bruising to the generator site on left side of chest and arm. Patient was implanted with vns approximately a month prior to the event. Patient did not have a fever. The patient later had surgery to remove the generator and electrodes as it was infected and abscess was present. Per the medical professional, it seemed like an isolated stitch infection but the doctor recommended removing the whole thing. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6632410
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #11 on: June 04, 2019, 08:08:53 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2006
Event Type  Injury   
Event Description
It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure. The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out. The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".
 
Manufacturer Narrative
Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.
 
Event Description
It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures. It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever. Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness. The surgical notes indicated that the incision sites were irrigated with bacitracin solution.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma. (b)(4).
 
Event Description
The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent. It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle. It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender. The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture. It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6808989
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #12 on: June 13, 2019, 03:25:50 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation not needed because the reported events have been determined as not related to vns therapy and stimulation. (b)(4).
 
Event Description
Report received that a patient's generator was exposed in the left chest. The patient was reportedly admitted to the hospital and put on antibiotics before the generator was to be explanted. Further information was received that the patient's neurologist believed an infection caused the generator to extrude from the skin, but the origin of the infection was reportedly unknown. Further information was received from operative notes that about a month prior to the extrusion, the patient presented with multiple erythematous areas over her neck and chest. It was noted that the patient's neurologist evaluated these bumps and determined they were related to insect bites. However, it appeared the patient did not recover with antibiotics and the generator began to extrude from the wound. It was not stated whether these insect bites led to the infection. The patient's mother reported that the site opened up and a gush of red tinged drainage was seen. The op-notes stated that during the explant, the generator was removed and the wound was cleaned. They also indicated that the surgeon removed some scar tissue in the generator area while performing the surgery. A review of the device history record indicated the generator had been properly sterilized to specifications prior to release for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7047271
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #13 on: July 11, 2019, 01:40:48 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient experienced itching of the left neck and left chest where the lead and generator were implanted. The patient was referred to a dermatologist. It was determined that the patient had chronic atopic dermatitis that was initially determined to be unrelated to vns. It was later reported that the itching was related to a metal allergy. The itching sensation caused the patient to scratch his neck and chest incision wounds, causing redness to the site. The patient underwent lead and generator explant surgery. The device history records were reviewed for the lead and generator and revealed that both devices were sterilized according to specifications prior to release for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7662834
Logged
Pages: [1]   Go Up
Print
Jump to: