Pages: 1 2 [3] 4 5 ... 10
 21 
 on: May 23, 2019, 11:17:55 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury   
Event Description
Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.
 
Event Description
Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551029

 22 
 on: May 23, 2019, 11:15:55 PM 
Started by dennis100 - Last post by dennis100
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

 23 
 on: May 23, 2019, 11:13:09 PM 
Started by dennis100 - Last post by dennis100
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

 24 
 on: May 23, 2019, 11:11:25 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/06/2017
Event Type  Injury   
Event Description
It was reported by a medical professional that a vns patient developed an infection related to vns. She developed an abscess 2-3 months after her vns was implanted and has failed several courses of antibiotics. The patient has been on bactrim and 2 courses of clindamycin. The infection was located on the lateral aspect of neck incision. The patient had been on 6 weeks of clindamycin and her incisional infection was looking good at the time. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery related to the infection has occurred to-date.
 
Event Description
Follow-up from the physician provided that he believes the lead is too superficial so he is planning to do a lead revision and move it deeper on the vagus nerve, and he believes this is the reason for the patient's continuous inflammation.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
It was reported that the patient's generator and lead were explanted due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6669021

 25 
 on: May 23, 2019, 11:10:37 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/02/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient was seen by his primary care physician due to concerns of a possible infection. The primary care physician noted that the patient had keloid formation, purulence, pain, warmth, and erythema all present in the chest area or at the generator incision site. The physician believed that the infection was caused by the patient's severe case of chest acne, which was incredibly active around the generator incision site. The combination of the bacteria from the acne and the incision site led to the possible infection, according to the physician. The patient was later referred to his implanting surgeon for follow-up. The patient was seen by his implanting surgeon. The patient reportedly had an abscess at his generator incision site, according to the surgeon. Cultures were taken and confirmed the presence of the infection. The patient was told to continue taking his antibiotic medication, which appeared to be related to his acne. The patient was seen one week later by the surgeon, and the infection at the incision site began to heal. No additional intervention was taken for the patient's infection. The device history records for the lead and generator confirmed that the devices met all sterilization specifications prior to distribution. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6672229

 26 
 on: May 23, 2019, 11:09:55 PM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient developed an abscess at the electrode site 2-3 months after her vns was implanted. Several courses of antibiotics had failed to clear the infection, so explant surgery was planned. Both the generator and lead were explanted due to the infection. The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668838

 27 
 on: May 23, 2019, 11:08:29 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/06/2017
Event Type  Injury   
Event Description
It was reported by a medical professional that a vns patient developed an infection related to vns. She developed an abscess 2-3 months after her vns was implanted and has failed several courses of antibiotics. The patient has been on bactrim and 2 courses of clindamycin. The infection was located on the lateral aspect of neck incision. The patient had been on 6 weeks of clindamycin and her incisional infection was looking good at the time. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery related to the infection has occurred to-date.
 
Event Description
Follow-up from the physician provided that he believes the lead is too superficial so he is planning to do a lead revision and move it deeper on the vagus nerve, and he believes this is the reason for the patient's continuous inflammation.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
It was reported that the patient's generator and lead were explanted due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6669021

 28 
 on: May 23, 2019, 11:06:16 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest. The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes. However, the physician noted there was no migration of the device and was fine. The explant occurred for the patient comfort as she simply wanted it removed. It was also reported the patient believes the device was causing her psoriasis. Explant surgery occurred. The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.
 
Event Description
Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns. The provider states the vns was working for the patient. Analysis was completed for the returned generator. Functionality of the generator to provide the programmed output currents was successfully verified. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed for the lead. The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666114

 29 
 on: May 23, 2019, 11:04:23 PM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2017
Event Type  Injury   
Event Description
It was reported that the patient's vns was bothering her in her neck and shoulder. The physician referred the patient for generator replacement surgery due to the pain and for better seizure control. It was later reported that the patient's vns generator was completely depleted, which indicated that the issue that the patient was experiencing in the neck and shoulder were most likely not related to stimulation. Attempts for further information were unsuccessful to date. No known surgical intervention has occurred to date.
 
Event Description
The patient's mother reported that the patient also felt an electrical shock throughout her body when the device went off, and the physician told her that this was normal. The patient also reportedly experienced lead protrusion and discomfort. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6682630

 30 
 on: May 23, 2019, 11:02:13 PM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury   
Event Description
Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.
 
Event Description
Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551029

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