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dennis100
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« Reply #210 on: April 24, 2019, 02:10:33 AM »

Model Number 303-20
Device Problems Fracture; Low impedance
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient¿s device showed low impedance. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the physician provided the device has had increasing impedances values since (b)(6) 2016, resulting in high impedance. The patient reported that she has not had a seizure in two months but she has had a mild shock near the generator site. The patient has denied any trauma or manipulation. No known surgery has occurred to-date.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The physician later provided the patient had high lead impedance still and was referred for lead revision. The patient states she has been having pain on the left side of the neck by the lead for the vns and has heard a cracking noise. She states that she is having pain on the left side of the chest where the magnet is and states there is swelling on that side, and feels like little knots. The patient states that when she lay on the left side of the neck it hurts and feels like it crackles. The patient states that she start having tingling like feeling 2 weeks ago, states that feels like having electric shocking.
 
Event Description
Follow-up from the physician¿s office provided that the swelling was not related to vns, even though the lead impedance is high.
 
Event Description
Follow-up was received indicating the patient does not want to go through with the revision due to her age and other health issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6191236
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dennis100
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« Reply #211 on: April 26, 2019, 06:46:07 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2016
Event Type  Injury   
Event Description
It was reported on that a patient had been experiencing swelling at her generator site and drainage at her neck incision site for about 1 year. The neurologist sent the patient to the emergency room in response. It was later reported that the patient was admitted to the er after presenting with an acute fistula between the neck incision site and generator site and swelling at the generator site. The patient was discharging a serous fluid from her neck. The device could not be explanted, so the patient was prescribed an antibiotic for one week and discharged from the hospital. Device history records were reviewed and confirmed that both of the devices were sterilized prior to release. No additional relevant information has been received to date. No known surgical intervention has been taken to date.
 
Event Description
It was reported that a patient's lead and generator were explanted due to infection, per the patient's surgeon. No additional information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6283113
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dennis100
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« Reply #212 on: April 29, 2019, 05:53:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's generator had extruded, described as "it is hanging out. " on (b)(6) 2017, the patient was given antibiotics as her incision site looked red and infected. The next week, on (b)(6) 2017, her generator was exposed and you could see pretty much the whole generator. Therefore the generator was removed the next day. The lead was cleaned, irrigated and then placed back in the pocket. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Event problem cds (refer to coding manual), corrected data: supplemental mdr 1 inadvertently did not report patient code (b)(4).
 
Event Description
Clinic notes from the day prior to generator explant surgery were received that indicated that the patient had been feeling fine until, a week prior began to have pain at the generator site with redness and yellow drainage. The generator had reportedly migrated again and she was given keflex for infection. At this time, the patient was 2 months post-partum of note, the patient's generator had been attached with non-absorbable sutures during her repositioning surgery in (b)(6). Operative notes reported that the patient who had a generator repositioning surgery in (b)(6) (captured in initial report) had redness and swelling at the vns generator site and was placed on antibiotics. The patient's skin eroded and exposed the generator. The patient's wound was classified as dirty. Return of the suspect product is not expected. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead was explanted due to lead-pulling issues with resultant vocal cord issues that were attributed to poor strain-relief, which is captured in mfr report #1644487-2018-00885. It is possible that the strain relief of the lead was affected by the migration. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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dennis100
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« Reply #213 on: May 01, 2019, 12:55:48 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/11/2017
Event Type  Injury   
Event Description
Information was received indicating that the patient had been seen in emergency rooms for possible concerns of infection and neck swelling. The patient was prescribed antibiotics. There was no noted trauma or patient manipulation that contributed to the infection. The patient then underwent an explant procedure. The device history record was reviewed for the lead and generator. Both were sterilized prior to leaving the manufacturing facility. No device return is expected. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6323706
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dennis100
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« Reply #214 on: May 01, 2019, 12:56:39 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
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dennis100
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« Reply #215 on: May 03, 2019, 02:21:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/23/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by manufacturer, additional information: analysis of the implanted device is not required for the reported event as it would not provide any additional relevant information.
 
Event Description
A medical assistant sent an email to a cyberonics employee stating the patient was scheduled for a surgery to revise the incision site and possibly explant the device. This was due to swelling at the generator site from a recent surgery. At the surgery, the surgeon repositioned the lead and took cultures to determine if the site was infected. The cultures came back positive meaning the site had become infected, resulting in the physician explanting both the lead and generator. A review of the manufacturing records showed that both the lead and the generator were sterilized prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6438766
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dennis100
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« Reply #216 on: May 05, 2019, 01:04:18 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that a patient had an infection at the vns lead site. The patient's lead was removed due to the infection, but no new device was implanted as a result. The patient first began experiencing some pain and swelling at the site previously and it was found that the patient had an abscess at the site, which led to an infection. A review of the device history record showed that the lead had been manufactured and sterilized per manufacturing specifications. The physician indicated he believed the vns device was related to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6412728
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dennis100
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« Reply #217 on: May 07, 2019, 07:31:36 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue. Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator. It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge. The patient denied fever, chills, or any change in status and the generator was still functional. Subcutaneous fluid collection and swelling were also noted at the generator site. The patient was referred for explant of the generator and the lead. It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient underwent vns explant on (b)(6) 2017. The physician did not know the cause of the migration.
 
Event Description
It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6398375
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dennis100
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« Reply #218 on: May 09, 2019, 07:23:36 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/06/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4). Device evaluation is not necessary because the reported infection is not related to vns therapy.
 
Event Description
It was initially reported the patient may have a potential infection that may result in vns removal. The surgeon explained that the patient's wound had split slightly at the chest incision site and they were optimistic it was external and at the suture closures, but the issue still didn't resolved. An additional antibiotic was prescribed. Later it was reported that the patient will have the vns removed due to infection. Clinic notes were received in regards to the referral for explant. Within the notes it was stated that after the patient's normal generator replacement, the patient developed a postoperative infection, which was treated with multiple antibiotics for several months. However, despite the patient being on antibiotics for several months, the wound continues to drain yellow fluid periodically and also swells up. Previously the patient had a fever, but he has not had the fever recently. The infection does appear painful. An attempt to cauterize the wound site did not stop the drainage of yellow pus. The patient's vns generator has since been explanted. Review of the device history record for both the lead and the generator confirmed sterilization prior to distribution.
 
Manufacturer Narrative
Operator of device, corrected data, initial report inadvertently selected incorrect device operator name and address, fax, #, corrected data, initial report inadvertently contained incorrectly-formatted fax number.
 
Event Description
The patient later underwent lead explant surgery due to continuation of the infection. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6521723
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dennis100
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« Reply #219 on: May 11, 2019, 02:19:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2019
Event Type  Injury   
Event Description
It was reported by the patient that their generator pocket had ripped and the generator was lower than it should be following the patient lifting a heavy object. The patient reported that when they went under an overpass they believed the magnetic force of the wires in the overpass caused paralysis of their vocal cords, caused their lead wire to become taut, pain in neck, and their voice to become hoarse. The patient indicated that their neck was bruised and swollen from the stimulation that occurred due to the overpass and felt like their leads were going to come out of their neck. The surgeon's office indicated that the entirety of the reported adverse events experienced by the patient were related to the migration of the generator. It was reported that the generator was secured during initial implant surgery using a "butterfly wing" suture technique; however, the type of suture was not known. It was reported that the patient was referred for a pocket adjustment. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8562974

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dennis100
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« Reply #220 on: May 11, 2019, 02:20:07 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Injury   
Event Description
It was reported that the patient had swelling in their neck since surgery that has not gone away. The patient¿s wife reported that the swelling is filled with fluid and is really mushy, and goes from collar bone to his neck. The patient¿s neurologist had determined the swelling was not related to vns stimulation. Per the patient¿s neurologist, the reason for the swelling was not known. The patient was referred for replacement of their lead. Attempts for information from the surgeon have been unsuccessful to date. Device history records were reviewed for the devices. The device was sterilized and passed all specifications prior to distribution. Surgery is likely but has not 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=8473236
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dennis100
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« Reply #221 on: May 11, 2019, 02:21:32 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing an increase in seizures due to lowered vns settings. The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements. The patient stated that the generator tested ok, but questioned if there could be issues with the generator. The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains. After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke. The patient reported their neck was twitching and was swelling, and there was severe issues with talking. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557527
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dennis100
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« Reply #222 on: May 14, 2019, 01:11:30 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/24/2017
Event Type  Injury   
Event Description
It was reported that a patient had redness, pain, and swelling at her incision site a few weeks after surgery. The site was reportedly fine 7 days after surgery. The patient was administered antibiotics and was reportedly doing a little better. The patient then had an ultrasound performed and her site was still infected after the antibiotics. The manufacturing record for the implanted generator confirmed proper sterilization prior to release for distribution. No known surgical intervention has taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6484987
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dennis100
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« Reply #223 on: May 23, 2019, 11:13:09 PM »

Model Number 106
Device Problems Energy Output To Patient Tissue Incorrect; Under-Sensing
Event Date 05/27/2017
Event Type  Injury   
Event Description
It was reported on the day of replacement surgery that the patient had fluid buildup around the generator site that made the patient's treating nurse practitioner refer her for the surgery. He believed that this build-up was causing the patient to have an increase in seizures. System diagnostics were within normal limits. The generator was replaced. Follow-up from the nurse practitioner found that the replacement surgery was conducted to preclude a serious injury. He believed that the fluid pocket had been caused by an infection and had caused the increased in seizures. He suspected effusion around the generator site, and indicated that the generator could not be interrogated. He said that the patient's seizures weren't worse than they would be without the vns and indicated that infection was a possible contributory factor to the patient's increased seizures. The company representative indicated that he could interrogate the patient's generator and there was no infection on date of surgery, per the surgeon's test of the fluid around the site. He indicated that the surgeon wasn't sure of the purpose of the surgery. The patient's mother was apparently very insistent that the surgery occur. Follow up with the surgeon's office found that the fluid at the site of the generator was sterile, no bacteria or infection. The fluid was just a collection of white blood cells. They indicated that they didn't know the cause of the fluid build-up. They indicated that prior to the replacement surgery the patient had had a streptococcus infection, but that they believed she had recovered from it. The office indicated that prior to being implanted with the vns, the patient had many seizures, but after the vns was seizure free. The patient had began to have many seizures again, which was the reason for surgery, but that they didn't believe that the vns was worsening the patient's seizure rate. They said that the increased seizure rate was why the patient's surgery was to preclude a serious injury. When the patient had the increased seizure rate, the patient was admitted to the hospital and placed under a heavily medicated coma. Her magnet swipe didn't register on the tablet. The office indicated that they believed the device was shallow and easily palpable. The office also indicated that they thought that the autostimulation wasn't working. They said that they didn't believe that the vns was causing the seizures directly but that a malfunction had caused loss of therapy. They indicated that the fluid build-up was likely a coincidence and wasn't related to the seizures. Further follow-up with the patient's nurse practitioner found that the infection he had referred to prior was a streptococcus sepsis infection with toxic shock, that wasn't alleged against the vns, but that he believed could have caused the fluid buildup. He hadn't known that the fluid in the vns pocket wasn't infected. He said that he didn't know why the office had said that her infection had resolved as she was still on antibiotics for the infection at the time of the seizures. He provided the following timeline. From (b)(6)2017, the patient was hospitalized due to her infection. On (b)(6)2017, the patient went to the hospital due to the fluid build-up at the generator site. On (b)(6)2017, the patient began to have many seizures and the patient was intubated for her medications. She underwent replacement surgery on (b)(6)2017. He said that the failure to interrogate he had noted in his first follow-up was actually the failure of his tablet to pick up the magnet swipe. However, he indicated that there was a lot of fluid between the skin and the generator, which he believed increased the distance between the generator and the magnet enough that the magnet was not able to activate the generator. He said that the surgeon had been able to detect the magnet swipe on his tablet without issue after the fluid was drained, and the nurse practitioner had had no issues with detecting magnet swipes on other patients at that time. He said that he didn't believe that the autostimulation or the generator was malfunctioning, but he had thought that the fluid build-up may have caused issues with the generator and caused effusion. When asked whether he thought that the strep infection, antibiotics, or the fluid build-up had caused the increase in seizures, he said that there were so many pieces to the story it was difficult to know what had caused the increase in seizures. He said that he hypothesized that the swelling was caused by effusion from the sepsis that the patient had underwent, the explanted generator was discarded, no further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial mdr inadvertently omitted the following statement " it was reported that the surgeon believed that the fluid around the generator could have been from someone trying to inject fluid into the port on the patient's chest, but accidentally doing this into the generator site instead.
 
Event Description
It was reported that the surgeon believed that the fluid around the generator could have been from someone trying to inject fluid into the port on the patient's chest, but accidentally doing this into the generator site instead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666127
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dennis100
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« Reply #224 on: May 23, 2019, 11:15:55 PM »

Model Number 103
Event Date 06/05/2012
Event Type  Injury   
Event Description
It was reported that a vns patient had their vns generator lead body explanted for an infection. The patient was doing well but over the last 2-3 weeks he has had progressive bogginess and swelling of the site especially the chest area, without fever or elevated white count. He presented to the emergency room where an ultrasound of the chest area showed a fluid collection. This was tapped and showed gross purulence. Cultures had not yet confirmed the event but there is clear evidence of an infection. He was sent to surgery for debridement and removal of their vns system. There was clear pus in the generator pocket of the left chest region. There was no gross evidence of bacteria in the neck area. The removal went down to the wire as it entered the carotid sheath. Distal ends of the lead were left in place.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2645557
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dennis100
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« Reply #225 on: May 30, 2019, 06:18:21 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/03/2017
Event Type  Injury   
Event Description
Patient is consulting the surgeon for possible infection. Cultures will be requested to confirm the presence of an infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information could not be obtained.
 
Event Description
The patient was seen by the surgeon as the patient's generator site became swollen and red. This had resolved after 3 days with no antibiotics taken by the patient. The doctor believed it was some residual swelling around the generator. During the visit, the doctor noted puffiness over the top of the generator, possibly some fluid in the pocket around the generator and stated that there is no erythema present but the site was a slight pinkish. There was no tenderness. The doctor was concerned with the fact that the patient may have a sub acute infection of the vns generator pocket and so prescribed clindamycin 300 mg 3 times a day and discussed the possibility of possibly aspirating the fluid in the pocket of the generator. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6612952
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« Reply #226 on: May 30, 2019, 06:20:26 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/18/2017
Event Type  Injury   
Event Description
It was reported that a patient developed an infection at his generator site shortly after vns surgery. Antibiotics were administered when the infection first appeared, and the infection began to recede. No additional medical intervention was taken for the patient's infection. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
Progress notes from the patient's surgeon indicated that the patient experienced swelling at his generator site. Specimens were taken from the neck incision site and no infections were identified. The patient's generator incision site also had a slight wound opening of 2-3 mm. The patient reportedly had a massive keloid which the physician believed contributed to the patient's swelling and wound dehiscence. The patient was given antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610062
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dennis100
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« Reply #227 on: May 30, 2019, 06:21:15 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
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« Reply #228 on: June 01, 2019, 03:41:38 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/22/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that she had her vns disabled several years ago however following a recent altercation she developed a knot and swelling in her neck at the vns electrode site. She also began having severe headaches and dizziness along with episodes of passing out and trouble breathing. Because of the symptoms the patient was concerned that her vns lead was damaged during the altercation and causing these symptoms. A review of the internal programming history database found that the normal mode output current was disabled however the magnet mode was left programmed on. Its unclear if the magnet mode was later programmed off. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6728030
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« Reply #229 on: June 02, 2019, 07:08:11 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported low grade fever and swelling have been determined to not be related to vns therapy. Should surgery occur for the device, evaluation will not be relevant to the report.
 
Event Description
It was reported by the patient that they had been experiencing a low grade fever a neck swelling after the vns implant surgery. Due to the fever and swelling the patient was put on antibiotics by the physician. A review of the manufacturing records was performed and both the lead and generator were shown to have been sterilized 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=6724142
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dennis100
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« Reply #230 on: June 04, 2019, 08:02:06 AM »

Model Number 102
Event Date 08/12/2010
Event Type  Injury   
Event Description
It was initially reported by the (b)(6), that a call was rec'd from the vns pt's mother that her son was having fluid buildup around the vns device. Later, information from the pt's mother indicated that a pocket of fluid was right over top and around the generator. If they touch it, they can definitely feel the fluid, but do not know whether it is blood or fluid. She stated that it covers the whole generator. Her son is implanted with one of the bigger generators and normally they can see the outline of the device under the skin, however now they can't see it at all. The pt was not known to have had any trauma since the pt's sitter/sister are very watchful over the pt. There wasn't any bruising or redness in the area to suggest infection. The pt also had a low-grade temperature over the weekend prior and he was given otc motrin. There was no recurrence of the temperature. There did not appear to be any pain or any discomfort. The pt was also said to have been sleeping longer than before, which started before the site swelling. The surgeon opted to initially monitor the issue. Later it was indicated that the pt was referred for generator explant due to the swelling at the site and to rule out infection as a precaution. Additional information was rec'd from the surgeon's office. It was indicated in the clinic and op notes that the pt's cultures were negative and the wound was benign. The pt was said to be explanted due to the swelling at the site. It was not clear as to what caused the issues reported, but due to the possibility of infection, the pt's device was removed as safety precaution. The physician did not believe the device caused the infection. There was no pus or signs of infection. When asked about the reported fatigue and fever, the notes did not provide any indication of the issue, but was part of the reason he was referred for explant. It was said to have cleared up after explant, but there is no way to determine if it was related to the swelling. The pt was said to have been seen at the emergency room for the low-grade fever and lethargy. The pt was seen on 09/23 for f/u on the recently implanted generator and there was no observable infection. All appeared to be acceptable for the pt. The explanted pulse generator was returned to the manufacturer for analysis, which confirmed there was no device malfunction. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator. The manufacturer dhrs were searched confirming lead and pulse generator sterilization prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846171
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dennis100
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« Reply #231 on: June 04, 2019, 08:02:46 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
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dennis100
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« Reply #232 on: June 08, 2019, 05:40:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported infection and generator site scarring is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient had both their generator and lead explanted due to infection. The referring physician confirmed that the infection occurred at the generator site, with the patient experiencing swelling and an abscess at the generator site due to infection. It was also noted that the explant surgery referral included a request for a scar revision. The scar is located at the generator site and the physician had no further assessment on this scar, stating that the request for revision was made since the patient was already being referred for surgery. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8616456
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« Reply #233 on: June 09, 2019, 01:03:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, (b)(4).
 
Event Description
It was reported that the patient had an infection at both the lead and generator site. The patient was initially implanted approximately a month prior to the report. The manufacturer's device history records were reviewed and it was verified that the lead and generator were sterilized prior to distribution. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's generator and lead were explanted. The patient reportedly had a tuberculosis infection. The patient reported that she went to the er on (b)(6) 2017 vomiting, swelling, and a feeling like she had something "pressing against her trachea. " the er told her that her post-operative swelling was normal. The neurologist prescribed iv fluids and zofran. Then, she woke up with purulent discharge from her neck incision and she went to the er on (b)(6) 2017 where she was treated with antibiotics and after 24 hours was referred for explant and transferred via ambulance, she was diagnosed with a postoperative infection and treated. On (b)(6) 2017 they lavaged her device but on (b)(6) 2017 took her to the hospital and explanted her vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6854331
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« Reply #234 on: June 11, 2019, 01:04:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.
 
Event Description
Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245
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« Reply #235 on: June 13, 2019, 03:18:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2017
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
A patient's father reported that his son experienced an infection and redness around his vns after a recent full revision surgery. The device history records were reviewed for the lead and generator and revealed that the devices were sterilized according to specifications prior to release. No additional relevant information has been received to date.
 
Event Description
The patient's neurologist reported that the implanting surgeon explanted the patient's vns due to the infection. Clinic notes were received and indicated that the patient's primary care physician observed a skin problem and rash. The patient was admitted to the emergency department for worsening swelling and spreading erythema around the vns generator. The patient was noted to be itching at the sites. Antibiotics were administered. The patient underwent lead and generator explant due to the supposed infection. The patient had attended a surgical consult two days prior to surgery and exhibited signs of progressive erythema, when it was recommended that the vns be removed. Operative notes indicated that the patient had a 2-3 cc seroma around the generator without obvious sign of infection. The generator and leads were removed and sent for culture, as well as a culturette of the generator pocket itself. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7061966
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dennis100
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« Reply #236 on: June 15, 2019, 11:32:42 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 10/10/2017
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient recently had a generator replacement, where pin insertion was checked, and lead impedance was ok at the time of replacement, but high lead impedance was observed a few days after the replacement. It was reported that the patient has experienced a significant increase in seizures that are stronger than their usual seizures. The patient also exhibits swelling on the left side of the neck as well as a low grade fever. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's lead was replaced. The device has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead has been received by the manufacturer for product analysis. Analysis is underway but has not been completed to date. No other relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Lead analysis was completed. Abraded openings were noted on the outer and the inner silicone tubing where dried remnants of what appear to have once been body fluids were present within the inner and outer silicone tubing. There was corrosion observed on the connector pin and there was indication that pitting or electro-etching occurred in the vicinity of the set screw marks. There was a portion of the lead not returned for analysis so a full evaluation could not take place. The high impedance report was not verified by product analysis which could be due to the whole lead not being received. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6998994

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dennis100
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« Reply #237 on: June 17, 2019, 04:27:36 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via clinic notes received that the patient was having on and off swelling around the vns site as well as pressure. The patient felt that the vns had shifted or moved and found it hard to lift anything. It was revealed that the patient was looking to have the vns explanted as, additionally, a few years prior, the patient had the vns disabled as it seemed to worsen her shortness of breath, due to the vns sitting over the top of the lung that tended to develop pneumonia. The vns was disabled and the patient expressed relief and stated that she could draw a full breath. The patient also reported that she had not noted any real benefit with the vns. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's device was explanted. The explanting facility discards product, so no analysis could be performed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7003137
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« Reply #238 on: June 18, 2019, 12:46:55 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2008
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A patient reportedly developed swelling and redness at his vns generator site shortly after his vns was initially implanted. The physician identified the swelling and redness to be a hematoma in the patient's generator pocket. The patient underwent surgery to drain the hematoma. During the surgery, an area of oozing was observed in the pocket. Cultures were obtained, but there was no evidence of infection noted, per operative notes from the surgery. The physician stated that he did not believe the hematoma was related to implant surgery, but rather to trauma that occurred after the patient fell or patient manipulation of the wound. The patient was evaluated several weeks after surgery and the hematoma reportedly resolved. The device history records were reviewed for the patient's lead and generator and revealed that both devices met all specifications for sterility 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=7144702
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« Reply #239 on: June 18, 2019, 12:48:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a physician (b)(6) 2017 that they were disabling a patient¿s device as the patient has chronic airway obstruction, and it has been getting much worse lately. She does not think that vns is a part of it, but the patient will be getting a tracheostomy, which is also independent of the vns, but she would like to turn the vns off for this procedure, and will titrate the patient back up afterwards. The doctor then mentioned that this patient has been having some vocal cord swelling recently within the past few weeks, which might also be contributing to the intermittent airway problems. It was mentioned that this patient has had airway problems before having his vns implanted, but believes the vns is aggravating the vocal cords, causing them to swell, which may be exacerbating the airway issues for this patient. It was also mentioned that this was the opinion of the patient¿s ent. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the provider indicated that the vns stimulation was not causing the vocal cords to swell and the swelling was unrelated to vns. The physician stated they had not done a lead test. The swelling of the vocal cords was indicated to be affecting the patient¿s airway and needed a trach, however the airway effect was independent of the vns. The problem existed prior to vns insertion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140324
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