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Author Topic: Cyst/Abscess  (Read 5866 times)
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dennis100
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« Reply #60 on: April 26, 2019, 06:44:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2016
Event Type  Injury   
Event Description
A report was received indicating that an abscess or blister had developed on the patient's chest incision. The reported indicated that the abscess was not leaking but appeared filled with pus and indicated that the wound appeared dehisced. It was unclear what caused the abscess/blister to form. The patient then sought treatment at an er when the abscess/ blister ruptured. The patient was prescribed antibiotics to treat the infection that was found when the abscess/ blister ruptured. The antibiotics reportedly cleared the infection. The device history record for both the generator and lead were reviewed. It was found that both devices had been sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6232562
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dennis100
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« Reply #61 on: May 06, 2019, 03:31:37 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 #62 on: May 11, 2019, 02:16:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that a patient had a left breast abscess that was being treated with antibiotics. The person reporting the abscess did not believe it was related to vns. Device history records were reviewed for the implanted generator. The device 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=8495123
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dennis100
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« Reply #63 on: May 11, 2019, 02:17:08 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566643
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dennis100
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« Reply #64 on: May 20, 2019, 09:31:46 PM »

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 mfr? - device evaluation is not necessary because the reported event is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient was scheduled for explant due to wound infection. The device history records were reviewed for the generator and the lead and revealed that both devices met sterility specifications prior to release. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.
 
Event Description
The patient initially presented with a stitch abscess at his generator site one month after implant surgery. Three months later, the patient presented with a surgical wound infection at the generator incision site. The patient's surgeon believed that the patient picking at the incision sites caused the abscess and infection. Both the patient's lead and generator were explanted after the infection appeared. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6567728
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dennis100
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« Reply #65 on: May 23, 2019, 11:09:55 PM »

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
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dennis100
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« Reply #66 on: May 23, 2019, 11:10:37 PM »

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
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dennis100
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« Reply #67 on: May 23, 2019, 11:11:25 PM »

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
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dennis100
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« Reply #68 on: June 04, 2019, 08:00:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Report received that a patient had an infection at the generator site. It was also reported that the patient was a "picker". The patient's mother stated she noticed redness about a week prior to this report and put a piece of gauze over the incision. The patient was reportedly started on antibiotics. While being consulted for a replacement, it was found that the redness at the incision site was due to a stitch abscess. A review of the device history record indicated the generator had been sterilized properly prior to release for distribution. A review of the device history record indicated the lead had also been sterilized properly prior to release for distribution. The patient's lead and generator were reportedly explanted. No further relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6803361
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dennis100
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« Reply #69 on: June 08, 2019, 05:38:10 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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dennis100
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« Reply #70 on: June 09, 2019, 01:01:11 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events were not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had an abscess in their neck and that their lead was exposed. The patient was hospitalized for a neurosurgery evaluation and referred for a possible lead revision. It was reported that the physician assessed that the patient was no longer infected. Device history records indicated that both the lead and generator were sterilized per specifications and passed all quality tests prior to distribution. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8613778
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dennis100
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« Reply #71 on: June 25, 2019, 01:28:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported to a company representative on that a recently implanted patient developed an infection. The patient visited the neurologist on (b)(6) 2018 and there was suspicion of either an allergic reaction or infection. After blood results, the patient was sent back to see the neurosurgeon for infection. The vns system was totally explanted as an abscess was detected and the patient was put under antibiotics. The lead and generator were explanted. 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=7287277
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dennis100
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« Reply #72 on: June 25, 2019, 01:29:55 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient kept getting abscesses at the neck incision site. The abscesses were treated with antibiotics. However, if needed, they planned to excise the abscess and incision scar as well as implant the lead wires deeper, or explant the system. They doctor believed that the cause of the abscess was either a stitch abscess or the lead wires being too close to the skin. The device history records of the patient's lead and generator were reviewed. Sterilization of both products were verified. 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 had become more stable and would not have their device removed (in relation to the abscesses). No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7279597
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dennis100
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« Reply #73 on: August 10, 2019, 12:07:44 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2019
Event Type  Injury   
Event Description
Patient was referred for lead explant. The reason for lead explant was reported to be that there was a cyst on the lead. The physician's assessment of the cyst was an infection of the vns electrode. Design history records for the generator were reviewed. The generator was confirmed to have been hp sterilized prior to distribution into the field. The device passed all specifications. Design history records were reviewed for the lead. The lead was confirmed to have been sterilized prior to distribution and passed all specifications as well. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8829184
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dennis100
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« Reply #74 on: August 10, 2019, 12:08:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2019
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 by hospital employee that the patient was scheduled to have vns explanted due to an abscess believed to related to an infection. The device history record's of the generator was reviewed. The generator passed final quality and functional specifications prior to release. It was verified the device was sterilized prior to release. Information was received from the sales representative that per the physician the infection was located at the generator site superficially which was confirmed through x-rays and ultrasound and not at depth of generator. The cause of the infection was not discussed but was not believed to be related to vns. The neurosurgeon did not explant the device since the infection was superficial to the battery and felt by taking the battery out the patient could potentially drive a deeper infection. The area was packed to address the infection. Although it was identified that the abscess that was related to an infection was not directly caused by vns per the physician, given it's physical location directly over the generator, it is difficult to conclude that the generator did not contribute at all, therefore the conclusion of the event is unknown. No surgical intervention related to this event has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8826696
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dennis100
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« Reply #75 on: September 07, 2019, 12:23:32 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/22/2019
Event Type  Injury   
Event Description
It was reported that the patient has an infection. There is a small abscess present over the generator. The physician decided not to explant the device but to wash the wound out. Device history record was reviewed and showed that the generator was hp sterilized prior to distribution into the field. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8878842
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dennis100
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« Reply #76 on: October 12, 2019, 12:34:32 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/22/2019
Event Type  Injury   
Event Description
It was reported by the patient's parent that the patient had a cyst on the top of their left shoulder. It was reported that the cyst was slow growing and not alarming but needed to be removed. It was reported that the patient was to have their cyst removed as the patient could not tolerate local (anesthesia) "with that many stitches. " the device history records were reviewed and the device was sterilized prior to distribution and passed functional specifications and quality tests. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9070850
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