Pages: 1 ... 91 92 [93] 94   Go Down
Print
Author Topic: Infection  (Read 566480 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2760 on: August 11, 2018, 01:04:52 AM »

Model Number 104
Device Problem No Display / Image
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that there was concern about the patient's generator site. Additional information was received that the generator was extruding from the site and was visible. This was stated to be caused by an ongoing infection at the generator site that initially occurred during the patient's vns replacement surgery. There was an abscess that was draining at the site and topical antibiotics were prescribed. The patient was referred for surgery to address the issue and possibly explant the vns device. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686293
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2761 on: August 11, 2018, 01:05:17 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2018
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to an infection at the generator site. The site was stated to be red and scabbed in appearance. A review of device history records showed that both the lead and generator were 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=7687634
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2762 on: August 11, 2018, 01:05:48 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2018 that the patient's vns site was infected and that she was admitted to the hospital. That day, the patient's generator and lead were explanted due to cellulitis. The patient was still in-patient the day after explant surgery. Approximately, two weeks later the patient reported that she was in pain and that signs of infection remained. The manufacturer's device history records of the lead and generator were reviewed. Sterility of the products were verified. Product return is not relevant as infection is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7688105
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2763 on: August 11, 2018, 01:06:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2018
Event Type  Injury   
Event Description
Report received that a patient developed a post-implant infection from vns surgery. A review of the device history records for both the generator and lead indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7687448
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2764 on: August 12, 2018, 12:15:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
The patient reported developing swelling and seepage from the incision site indicating an infection has developed. The patient's generator was replaced three days before the report. Information was also received that the patient was seen by a surgeon who confirmed that part of the incision had separated. The patient was prescribed antibiotics for the infection. A review of device history records for the generator shows that no unresolved non-conformances were found and verified the generator was sterilized prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7664848
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2765 on: August 14, 2018, 12:43:50 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2017
Event Type  Injury   
Event Description
Clinic notes were later received providing that the device had been removed due to the infection on (b)(6) 2018.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
Clinic notes were received providing that the device had been removed due to the infection on (b)(6) 2018.
 
Event Description
It was reported that a vns patient was scheduled for explant of the generator and lead. The reason was later provided from the notes that it was because the vns incision has opened and is draining pus. Review of the manufacturing records for the generator and lead confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Date of event, corrected data: the event date was inadvertently provided incorrectly on the initial report. Event description, corrected data: the date of explant was inadvertently provided incorrectly on the event description in follow-up report#1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7287555
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2766 on: August 14, 2018, 12:44:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/03/2018
Event Type  Injury   
Event Description
It was reported that a patient's device was explanted due to an infection. It was noted that the infection was treated with iv antibiotics, but the antibiotics did not resolved the infection. Device history records were reviewed for the devices that were explanted for the infection. Both lead and generator were sterilized and passed all quality inspections prior to distribution. No further relevant information was received to date.
 
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient initially noticed redness, which was what prompted the appointment that led to device explant due to infection at the vns site(s). The cause of the infection at the vns site was unknown, but the patient did have a history of infection that was unrelated to vns surgery. There was no growth from the culture taken, so it could not be determined if the two infections were caused by the same bacteria. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7588490
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2767 on: September 02, 2018, 01:10:26 AM »

Model Number 102
Event Date 08/15/2010
Event Type  Death   
Manufacturer Narrative

Event Description
The cause of death was listed as pneumonia, septicemia, cardiac arrest, shock. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician indicated that the patient experienced, a reduction in seizures with vns therapy. The patient was receiving therapy at the time of death. The cause of death was listed as paraplegia with respiratory failure. It was noted that no autopsy was performed and the death was not believed to be related to vns therapy. The patient was compliant with medications and suffered respiratory arrest at the time of death.
 
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns are unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281651
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2768 on: September 07, 2018, 11:07:23 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
At the patient's first follow-up appointment after implant surgery, the patient stated feeling discomfort at the neck area. The physician initially believed to be a side effect of the implant procedure and did not believe there was an infection. Upon another appointment with the physician, it was stated the patient suspects an infection at the incision site. The patient was prescribed antibiotics. Device history records were reviewed for the implanted devices and both devices were sterilized and passed all quality inspections prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7836153
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2769 on: September 07, 2018, 11:07:52 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2018
Event Type  Injury   
Event Description
It was reported that a vns patient was in the emergency room most of the night and would have the vns explanted due to infection. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7825641
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2770 on: September 07, 2018, 11:08:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Event Description
Information was received that the patient developed an infection due to the vns implant procedure resulting in the explant of the vns device. The location of the infection was unknown however it was stated that the infection area had completely healed. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the infection has been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7833311
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2771 on: September 07, 2018, 11:08:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/28/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported infection has been determined as not related to vns therapy but rather the vns surgery.
 
Event Description
It was reported that the patient's generator was explanted due to an infection. The leads were left in place. A review of the generator manufacturing records showed that it passed all functional specifications 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=7834695
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2772 on: September 07, 2018, 11:09:27 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/13/2018
Event Type  Injury   
Event Description
It was reported that the patient was referred for a possible revision surgery and is currently admitted to the er. The surgery was stated to be a wound washout surgery. Design history record for the generator was reviewed. The generator was confirmed to have been hp sterilized prior to distribution. Further information and operative notes were received. Both the generator and lead were explanted. The patient is developmentally delayed and had been picking at the site prior to the surgery. The wound was fully open when he came in. Operative notes stated drainage and fever were noted. The cultures were consistent with infections; therefore, iv meds were administered in conjunction with his ancef. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? code 81, device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7790584
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2773 on: September 07, 2018, 11:09:57 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/27/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.
 
Event Description
It was reported that a patient's device was explanted due to infection. The patient had had a recent battery replacement surgery which had opened up. It was stated that the mom did not get an antibiotic order filled, so the wound led to infection and the device was visible. Device history records were reviewed for the implanted devices. Both the lead and generator were sterilized and passed all quality inspections prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7750790
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2774 on: September 07, 2018, 11:10:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2018
Event Type  Injury   
Event Description
It was reported that a patient was scheduled for a possible full revision due to a lead extrusion. Further updates indicated that the patient had an infection. The patient had stated that after a big seizure, he saw a blue cord showing through his left chest wall. The hole was stated to be the size of a dime at the vns generator incision site. Follow up with the surgeon's office stated that the patient had not been seen since the implant and that he was scheduled for a planned explant, leaving the leads implanted, on 07/23. They had heard the report of extrusion from the patient's girlfriend and assumed that the site was likely infected by now as the patient has had an open wound at his chest incision site. The surgeon's current assumption, based on the call received from the girlfriend, was that the wound opened and the lead was extruding due to a bad seizure that took place. An additional follow up from the surgeon stated that he believed the infection was due to the difficulties that occurred during the implant surgery in which incision sites were reopened for troubleshooting, thereby increasing risk of infection. Explant of the generator was confirmed to have occurred and it was stated that the patient remained in the hospital post-operation for iv antibiotics. The physician confirmed that the extrusion was related to the infection and body's rejection of the device. The infection was confirmed to be in the neck and chest and was determined to be possibly related to surgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7774054
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2775 on: September 07, 2018, 11:11:02 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was stated that the patient had a full revision surgery. The reason for the surgery was indicated to be due to infection of the leads. Follow up clarified that the patient's device was not replaced, and was just explanted due to infection of the lead. It was stated that the physician did not know the cause of the infection. It was unknown when the infection was first noted. Device history records were reviewed for the implanted devices. Both devices were sterilized and passed all quality inspections prior to distribution. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7776639
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2776 on: September 07, 2018, 11:11:37 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/12/2018
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
The patient's device was removed due to infection. The patient's incision site was tender to touch, and had redness and swelling. The surgeon decided to drain the site and then remove the device. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7783469
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2777 on: September 07, 2018, 11:12:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/18/2018
Event Type  Injury   
Event Description
It was reported that this patient received a generator replacement and did not remove his bandage for 7 days post-surgery and the generator site became infected. Additional information was received that the patient had a three day history of pain and redness. The incision site was red, inflamed and swollen, and therefore the surgeon admitted the patient for removal of the battery. It was stated that the patient's device was explanted due to the infection, which was stated to be mrsa. A review of device history records showed that the implanted generator was 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.
 
Manufacturer Narrative
Device evaluated by mfr? code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7751663
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2778 on: September 07, 2018, 11:12:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2018
Event Type  Injury   
Event Description
It was reported that the surgeon is planning to perform a vns battery replacement with possible explant due to infection. Patient is delayed and kept picking at incision site and has picked it open and is now infected. The patient¿s generator was recently implant in (b)(6) 2018. While explant is likely, no known surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7753035
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2779 on: September 07, 2018, 11:13:16 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2018
Event Type  Injury   
Event Description
Patient's generator was explanted due to infection. Surgeon had been managing an infected wound at the generator site for about a week and had decided that patient needed to be explanted and the wound cleaned. After explant, the wound was thoroughly cleaned with several types of antibiotic irrigations, both manual and electrically boosted. Surgeon then decided by to re-implant due to the localized nature of the infection and because the wound could be adequately disinfected at operation minimizing the chance of re-infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7826605
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2780 on: September 07, 2018, 10:18:24 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/03/2018
Event Type  Injury   
Event Description
It was reported that the patient was in the local hospital due to possible infection of his vns site. He had missed his post-op appointment. The patient was implanted three weeks prior. The surgeon indicated that the patient was noncompliant. The surgeon's office reached out to the patient multiple times and he failed to attend appointments or fill the antibiotics he was prescribed. He reported that he took left over antibiotics he had at home for a different ailment instead. The patient reported that he had a septic infection, but the hospital indicated that the patient was not septic, and rather had a small infection that he was given antibiotics for. However, later the patient was readmitted to the hospital for his infection and it was found that the patient was not taking his antibiotics. Two days later the patient was explanted due to the infection. The manufacturer's device history records were reviewed. Sterilization of the lead and generator prior to release was verified. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7791575
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2781 on: September 07, 2018, 10:19:18 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Following a generator replacement surgery, the patient underwent generator explant surgery due to wound break down and infection. A review of device history records showed that the generator was sterilized prior to distribution. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7795597
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2782 on: September 08, 2018, 12:41:43 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/06/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient is scheduled for vns explant due to infection at the lead site. Design history records for the generator and lead were reviewed on 08/01/2018. Both devices were confirmed hp sterilized prior to distribution into the field. Additional information was received that the patient did not have vns explant as the site looked much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7797626
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2783 on: October 05, 2018, 12:36:33 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient's vns was removed sometime in 2015 due to the lead eroding through the skin which resulted in an infection. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7916501
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2784 on: October 05, 2018, 12:37:58 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/10/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
At the patient's initial programming appointment, the surgeon identified subcutaneous exudate under the patient's chest implant site without swelling or pain of the skin. As a result, the patient was admitted to the hospital. During the hospitalization, the subcutaneous exudate was drained and the wound tested positive for non-resistant staphylococcus aureus. The patient was prescribed antibiotics and remained in hospital for observation. The device history records of the patient's generator was reviewed and sterilization of the device prior to release was verified. No further relevant 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=7900688
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2785 on: October 05, 2018, 12:38:45 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/10/2004
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns was explanted due to an infection at the generator site. The physician said that the patient was certain that the generator was explanted but unsure about the lead. The physician stated that the patient was currently interested in having another device implanted. Clinic notes were received and stated that vns was placed in 2004 but this had to be taken out just a few months later because he developed a staph infection. Follow-up with the physician showed that it was possibly due to vns implant surgery. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Corrected data, initial mdr inadvertently omitted information known prior to submission of the report.
 
Event Description
The design history record was reviewed for the generator and lead. Both the generator and the lead were confirmed to have been eo sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7856672
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2786 on: October 06, 2018, 05:18:58 AM »

Event Date 12/19/2005
Event Type  Injury   
Event Description
In (b)(6) 2005, i had a vagus nerve stimulator implanted for treatment resistant depression by a dr (b)(6) at (b)(6) medical center in (b)(6). (dr (b)(6) subsequently worked at (b)(6) medical center). Afterwards, i felt as if i were fighting off an infection. I informed the surgeon, but blood work revealed no infection. About three weeks later, however, my chest began puffing out like a balloon, and i was rushed to the hosp. According to my medical records, i was treated for an (b)(6) infection. I did not find that out until i requested the medical records some time later. The device was removed, and i was kept at (b)(6) med ctr for several days on iv antibiotics. Then i took iv antibiotics at home for a few more weeks, with a nurse coming over to replace the iv syringe in my hand every few days. Two months later, another vagus nerve stimulator was implanted by the same surgeon, who damaged my recurrent laryngeal nerve, leaving me unable to speak for a year. I will report that incident separately. (i assumed these adverse events were reported by the healthcare providers, and i was too severely depressed for years to even attempt to report these incidents myself. But now, years later, i want to be sure you know about these incidents). And i will file another report concerning severe sleep apnea caused by the second vagus nerve stimulator (which i cured in (b)(6) 2013 by having to demand that the neurologist adjusting the settings on the device turn it off, after suffering significant sleep apnea even on a bipap machine. At that point, i had found the studies revealing higher settings on these devices cause severe sleep apnea, severe depression, and cardiac arrest during sleep. But again, i will file separate reports for each of these incidents that contributed to the destruction of my health, disability, and having to live off ssdi since 2011. Of course, i do not have the first vagus stimulator that was removed in (b)(6) 2005. At the time the device was implanted, i was suffering from severe, unremitting depression because a psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania as a side-effect of sertraline, but not otherwise. Vns had no effect on my depression at the time, but the second vagus nerve stimulator nearly caused me to commit suicide because it was causing sleep apnea with an apnea hypoxia index of 47. On (b)(6) 2006, i had a second vagus nerve stimulator implanted for treatment-resistant depression after the first one had to be removed in (b)(6) 2006, because the surgeon infected me with (b)(6) while the first stimulator was implanted (i have submitted a report concerning that adverse event already). I have also submitted a report concerning damage to my recurrent laryngeal nerve when the second device was implanted, leaving me unable to speak for a year. Over the years, my psychiatrist, and then a neurologist, increased the output of the device. I had no risk factor for sleep apnea. I had been running literally 49 miles per week before i began to experience severe depression, in part as a result of settings for the device. I had a cpap sleep study on (b)(6) 2011, which revealed that i was not breathing between 10 and 30 seconds every minute of the night. My apnea hypoxia index (api) was 47. 4. The doctor who diagnosed me with sleep apnea told me that on a scale of 1 to 10 in severity, with 10 as most severe, he rated my sleep apnea as a 9. The settings on the vagus nerve stimulator as of (b)(6) 2011 were: parameters output current (ma): 1. 5, signal frequency (hz): 2. 0, pulse width (usec): 250, signal on time (sec): 30, signal off time (min): 5, magnet output current (ma): 1. 75, magnet on time (sec): 60, magnet pulse width (usec): 250, lead test/normal mode test output status (ok or limit): ok, lead impedance (ok or high): ok, dc-dc converter code (0-7): 3 eri flag (yes or no): no. Even using a bipap machine, my api fluctuated at scores from 8 to 40 until (b)(6) 2013. On that date, i brought several studies to my neurologist's office that proved indisputably that vagus nerve stimulation causes severe sleep apnea, severe exacerbation of depression and cardiac arrest during sleep. I was waking up for years feeling as though somebody had beaten my body with a baseball bat. The neurologist reluctantly turned the device off. That evening, and every subsequent evening since then, i have experienced no sleep apnea. I still have the product, but it is still implanted, and turned off. I do have the product packaging. Because i have the packaging, i will answer below that i do have the product. I weighed approximately (b)(6) pounds in (b)(6) 2011, as opposed to my weight listed in two other reports related to implantation of this device and a prior implantation of a vagus nerve stimulator. Lyme neuroborreliosis since 1980. Babesia microti infection since 1980, severe, unremitting treatment-resistant major depression from late 2003 to late 2006 because psychiatrist took me off medications i was taking for depression and put me on lamictal, zyprexa, etc. Merely because i experienced mild hypomania five days per month as a side-effect of sertraline; severe-to-extreme treatment-resistant depression from (b)(6) 2008 to present because a doctor caused extreme excitotoxicity by provoking a severe inflammatory immune response for an entire year while treating me far too aggressively for lyme disease, and also caused by vagus nerve stimulation. I was not able to reduce the depression to the moderate range until i discovered that buprenorphine acts synergistically with ketamine to reduce depression, and prevents tolerance to ketamine; i took the same dose of both medications for six years. I was able to get off 300mg intramuscular ketamine daily in six weeks, with no withdrawal symptoms, and with better results treating depression 1. 5 years ago when i began treating the cerebral cortex with a 30 watt, 810 nanometer (near infrared) laser that emits a collimated beam, in continuous wave mode for 50 minutes each evening. My nightly readings on my bipap machine, which i have saved, prove that when the vagus nerve stimulator was turned off, i no longer experienced sleep apnea that severely exacerbated my depression, and which caused extreme physical pain. After a vagus nerve stimulator had been implanted in (b)(6) 2015 and removed on (b)(6) 2015, a second vagus nerve stimulator was implanted by a dr. (b)(6) at (b)(6) medical center in (b)(6), on (b)(6) 2006. During the surgery, my left recurrent laryngeal nerve was damaged. I was unable to speak for an entire year. The surgeon casually told me that he did not know whether i would ever be able to speak again. For an entire year, i had to use as much energy as it takes to scream at the top of one's voice merely to make a rasping sound that was barely intelligible. I have a videotape with audio made about six months after the device was implanted, demonstrating the extent of impairment. I still have that video in digital format. The product itself is still implanted but turned off. Since the surgical procedure, not the product itself, caused the damage, and since the product is still implanted but turned off, i will answer below that i do not have the product so that you can evaluate it. I assumed at the time that the manufacturer or surgeon reported this, and then became too severely depressed as a result of sleep apnea caused by the vagus nerve stimulator (and also as a result of medical incompetence of a doctor treating lyme disease and babesia microti) that i was incapable of reporting it. A psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania five days per month as a side-effect of sertraline, but not otherwise. He took me off of sertraline and adderall, and put me on medications such as lamictal and zyprexa. In (b)(6) 2006, i finally felt capable of going to another doctor and asking to be put back on the medications i had been taking before i began seeing the psychiatrist who caused the three-year episode of severe depression. Within a week of being put back on those medications, i was not suffering from depression or mild hypomania. But the vagus nerve stimulator was implanted while the psychiatrist was causing me to suffer a three-year episode of severe, unremitting depression that was not responsive to ect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910123
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2787 on: October 06, 2018, 05:19:36 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns lead wire was extruding from his neck. The physicians wanted to explant the device as a result. Follow up by the tc revealed that there was no trauma or patient manipulation that could have contributed to the event. The physician's office believed that the patient was allergic to the vicryl sutures placed after surgery as the patient has been in almost weekly since the date of implant due to his body rejecting the sutures and pushing them out of his skin. It was stated that this caused abscess type problems around the generator and neck and that the patient has been back in previously to remove the sutures and clean the surgery site. It was later reported that the patient responded well to vns therapy, but had significant swelling around the generator and approximately 2 inches of the lead was protruding. The surgeon decided to explant the whole vns system and give the patient time to recover from the infection. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877560
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2788 on: October 06, 2018, 05:20:10 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient had presented to the local hospital due to an infection at the chest vns incision site. It was stated that the last time the patient was seen, the incision had been fully healed. The patient stated that one end of the incision had started to breakdown and was infected. The patient was given antibiotics, but a physician advised that he did not believe that antibiotics would work and the wound would need draining. The patient was concerned that the other end of the incision was opening and that she could feel a pocket of fluid. The patient underwent vns explantation surgery due to the infection. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877812
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52150


« Reply #2789 on: October 06, 2018, 05:20:51 AM »

Model Number 106
Device Problems Adverse Event Without Identified Device or Use Problem; Appropriate Term/Code Not Available
Event Date 08/24/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns was migrating and the patient was referred for exploratory surgery. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Follow-up performed by the company representative provided that the cause of the infection was unknown and was located at the generator site. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7895063
Logged
Pages: 1 ... 91 92 [93] 94   Go Up
Print
Jump to: