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dennis100
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« on: July 30, 2018, 03:30:43 AM »

Model Number 304-20
Event Date 08/01/2010
Event Type  Injury  
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Date of event, corrected data: additional information received indicates date of event is earlier than previously indicated.
 
Manufacturer Narrative

Event Description
Additional information was received from the physician indicating that the patient was explanted because she was a non-responder to therapy and was informed of the infection and electrode migration by the surgeon. No trauma or manipulation was believed to have occurred. The patient was reportedly able to feel when the vns was stimulating. The physician indicated that vns diagnostics were normal close to the time of removal however specifics were not provided. Follow-up with the surgeon's office found that approximately six weeks after the vns implant on (b)(6) 2010, the patient's vns electrodes began to extrude at the neck site. Surgery was performed to correct this however infections occurred intermittently requiring treatment with antibiotics. After battling infections for some time and no efficacy observed, the decision to explant the vns was made. At the time of surgery, drainage was noted at the neck site and a "pointing abscess" had developed at the generator site.
 
Event Description
It was reported that the patient would be having her vns explanted because "it did not work for her. " additional information was received from the physician indicating that the patient's device became infected following surgery and was not improving the patient's seizure control. The patient's vns was removed since it did not appear to help the patient's seizures. During removal of the patient's vns, it was noted that the electrodes had migrated off of the vagus nerve per the neurologist. Further follow-up with the physician's office found that no trauma or manipulation was believed to have occurred. The infection was present at the electrode site and is believed to be related to vns surgery. Cultures taken on (b)(6) 2012 indicated (b)(6). No vns diagnostics were available upon request; however, the site indicated the patient was last programmed in (b)(6) 2011. Attempts for the return of the explanted lead and generator were unsuccessful as per hospital policy, all explants are discarded. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2527430
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dennis100
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« Reply #1 on: July 30, 2018, 03:32:09 AM »

Model Number 302-20
Device Problem Improper or incorrect procedure or method
Event Date 10/01/2014
Event Type  Injury   
Event Description
Additional information was received that the patient underwent surgery. During the surgery, the physician noted that the entire vns lead and tie-downs were not previously removed. The physician also noted scar tissue formation around one of the arteries leading to the brain with a 50% chance of a stroke.
 
Event Description
It was reported that the vns patient was seen by a dermatologist due to a pimple on the patient¿s neck. The dermatologist removed the pimple and also pulled out what appeared to be a surgical staple from under the patient¿s skin. Subsequently, the patient¿s lead was extruding under the patient¿s skin and the patient began experiencing pain at the lead site. The patient¿s device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no know surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient has an abscess on the left side of his throat which is pressing on the vocal cord and could lead to vocal cord paralysis. A neck and chest ct was performed which showed that a part of the vns leads and a tie down were not explanted previously. The physician believes that the presence of the device may be contributing to an infection. Patient is scheduled to have the abscess drained. Attempts for additional relevant information were unsuccessful.
 
Event Description
Additional information was received that the patient's hoarseness has resolved per the ent. However the patient will never be able to speak loudly. Patient's neurologist decided to not replace the vns device as patient has had only one seizure since (b)(6) 2015.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient continues to have voice hoarseness that is better in the morning but worsens as they day progresses. According to the ent physician, the patient may need another surgery if patient's voice does not improve.
 
Event Description
Additional information was received that the patient will be undergoing another vocal cord surgery on (b)(6) 2015. Per the ent, the portion of the lead that was left implanted at the time of generator explant caused vocal cord infection, resulting in vocal cord paralysis.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 10/6/2015. The previous supplemental mdr #9 incorrectly lists the aware date as 08/04/2015. The correct aware date is 10/06/2015.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/08/2015. The previous supplemental mdr #7 incorrectly lists the aware date as 08/04/2015. The correct aware date is 09/08/2015.
 
Event Description
Additional information was received that the patient underwent explant of the vns generator and lead on (b)(6) 2014.
 
Event Description
Additional information was received that the patient continues to have voice issues and that the patient plans to have surgery to address this. Patient's seizures were reported to be under control.
 
Event Description
Additional information was received that the patient's voice is normal and that the patient is better currently.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274290
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dennis100
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« Reply #2 on: July 30, 2018, 03:32:50 AM »

Model Number 103
Event Date 04/07/2014
Event Type  Injury   
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead due to infection and subcutaneous abscess formation which resulted from patient manipulation of the device. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Other than typical wear and explant related observations, no anomalies were identified in the returned lead. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The patient has not been re-implanted to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300962
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dennis100
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« Reply #3 on: July 30, 2018, 03:33:48 AM »

Model Number 302-20
Event Date 11/20/2012
Event Type  Malfunction   
Event Description
Additional information was received reporting that he patient is doing better with seizures which they think is a result of better complains now that she is in a care facility and medications are regimented. They are going to wait before making a decision as to implant a new vns. Although lead re-implant may occur in the future, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the generator and lead was completed. The returned generator performed within all specifications during our electrical testing. There were no adverse functional, mechanical, or visual issues identified with the generator. Cyberonics received two portions of the lead assembly. During the visual analysis, the lead coil appeared to be discolored and dissolved, in some areas. During the visual analysis of the returned portion, breaks were noted near the end of the connector boot, and a break was noted near the electrodes. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Scanning electron microscopy (sem) was performed and identified the areas as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. Low magnification sem analysis of the coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Manufacturer labeling recommends disabling stimulation of the generator after observance of high lead impedance.
 
Manufacturer Narrative

Event Description
It was reported that the surgeon indicated that the sterile abcess may have been irritated due to lead dissolution. The replacement generator was remained implanted, and the surgeon intends to replace a new lead. Although lead replacement is likely, it has not occurred to date.
 
Event Description
It was initially reported that the patient had low impedance on (b)(6) 2012. Additional follow-up revealed that high lead impedance was actually observed on (b)(6) 2012, not low impedance. The patient has had multiple falls recently but unclear if that has any bearing. The device has not been turned off, per the physician. X-rays have reportedly been taken, but a copy has not been provided to the manufacturer to date. A copy of the radiology report indicated that pa and lateral x-ray views of the chest were performed on (b)(6) 2012. The lead appeared to extend off of the edge of the film, so it was indicated that a neck radiograph could help confirm the continuity of the lead. With the lead visible in the chest x-rays, no lead discontinuities were reportedly observed. The patient is being referred for replacement surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure occurred and cannot be ruled out as a potential contributing factor to the sterile neck abscess.
 
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013. Prior to surgery, the system showed high impedance (9407 ohms) upon diagnostics. Upon neck incision, it was noted that the patient has an abscess in her neck (infection). A replacement generator was opened, so the surgeon decided to remove the leads and implant the new generator but leave it off until neck healed and a new lead can be implanted. The infection was located around the lateral tie-down portion of the neck (about 1. 5cm x 1. 5cm) per the neurosurgery fellow. Additionally, a slight kink in the lead was noted by the surgeon. One culture of the infected area came back positive and the other two were pending on the date of surgery. The explanted generator and lead were received by the manufacturer on (b)(6) 2013, but product analysis has not been completed to date. The return product form indicated the reason for replacement as battery depletion and high lead impedance. Review of the lead and generator manufacturing history records confirmed that the devices were sterilized prior to distribution. Follow-up with the surgeon on (b)(6) 2013 revealed that the infection at the tie-down area may have been related to foreign body response or reaction to 'current leak. ' no patient manipulation or trauma is believed to have caused/contributed to the infection. The positive culture that was previously reported later 'gm strain was re-read as negative. ' the culture was negative.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Additionally, review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874145
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dennis100
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« Reply #4 on: July 30, 2018, 03:35:21 AM »

Model Number 103
Device Problem No Information
Event Date 08/06/2015
Event Type  Injury   
Event Description
It was later reported on (b)(6) 2016 that the patient was scheduled to have her lead explanted that day due to an abscess in the neck area. Operative notes from (b)(6) 2016 report that the patient presented for ¿left cervical surgical skin site ulceration caused by erosion of underlying hardware¿ and plastic surgery for keloid formation around the previous generator site incision site. The indications for operation indicated that the generator was previously removed due to complication through the skin. Subsequently, that area of closure developed keloid and more an area in the center of the cervical incision site began to thin out and there was a palpable piece of hardware beneath that thinned out site. It worsened to the point skin broke through and there was a yellowish drainage that came from the site. This was cultured. The patient was admitted and was on iv antibiotics and brought to the room for the to remove the generator, the ulcerated and then have the plastic surgery service revise both the keloid incision and the lead incision on (b)(6) 2016. During the procedure, it was observed that the ulceration site was through dermis and through platysma. The area of the lead strain relief was eroding through the skin. Once that was excised out, the remaining tissues deeper appeared normal. It was irrigated with antibiotic irrigation and then the majority of lead was removed. For the remaining lead portion, it was assessed that it was not able to be easily extracted from within the carotid sheath. It was determined that this was unacceptably risky and difficult because of the extensive amount of scar tissue there/ what was at that point the only remaining wires with the thin final portions of the lead. It was felt that there was no deep infection. The deep space was verified to be sterile. The area was treated with the 3% hydrogen peroxide and after that irrigated it with bacitracin irrigation. The keloid at generator site was removed and there was additional debridement at the generator site. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.
 
Event Description
The patient later had generator explant surgery on (b)(6) 2015 due to an infected pocket. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.
 
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital with an infection. The patient had pus around the generator site. The patient had surgery on (b)(6) 2015 due to the superficial wound infection in the chest. The procedure included debridement of the dermis and subcutaneous layer. The operative notes reported that the patient presented in clinic on (b)(6) 2015 with appearance of the incision overlying the vagus nerve stimulator generator with the appearance of thinning as though it was at risk of dehiscing. The next day, the patient was admitted with evidence dehiscence that had started to begun and there was also some superficial spreading redness, which had the appearance of cellulitis. Surgery was performed as an emergency procedure, and during the procedure, the site was debrided and irrigated. The surgeon concluded that the evidence was favorable to suggest that the infection was cellulitis only with skin edge dehiscence. The patient was then closed. The generator was not explanted. Good faith attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Analysis was completed on the generator. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5111592
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dennis100
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« Reply #5 on: July 30, 2018, 03:36:36 AM »

Model Number 102R
Event Date 04/14/2011
Event Type  Injury   
Event Description
Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.
 
Event Description
Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.
 
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098698
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dennis100
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« Reply #6 on: July 30, 2018, 03:37:37 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 06/18/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Changed suspect device to lead as initial mdr was submitted on the generator.
 
Manufacturer Narrative
If explanted, give date (mo/day/yr), corrected. Initial report inadvertently reported that the patient's device was explanted. Further information revealed that the device was not explanted.
 
Event Description
Additional information provided on (b)(6) 2015 found that the patient's devices were not ever explanted as previously thought. The vns continued to work until (b)(6) 2014 when high impedance was found. The high impedance is captured in mfr. Report (b)(4). Clinic notes received mention that the patient had an increase in seizure frequency as well as duration since implant so increase in seizures will be captured. The seizures seem to be related to the infection and occur when the patient is tired. Notes from (b)(6) 2015 state that the patient's neck site turned red 4 days ago. The abscess was drained and the patient was given antibiotics. It was then noted that the patient went to the er on (b)(6) 2014 and vns was not removed as the infection was found to be superficial.
 
Event Description
It was reported that the recently implanted vns patient underwent surgery on (b)(6) 2014 to explant her device due to infection. Clinic notes were received for the patient office visit on (b)(6) 2014. The patient was admitted to the hospital following implant surgery. It was reported that the patient was having several hundred seizures per day and that patient¿s seizures had been increasing in duration. Prior to discharge the patient¿s device settings were increased. Four days prior to the office visit, the patient went to the er where an abscess was found and drained. The patient¿s neck incision site began having redness from patient manipulation the same day the patient went to the er. The patient did not have any pain or a fever but was given antibiotics. The patient has not been re-implanted to date. Attempts for additional relevant information have been unsuccessful to date.

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dennis100
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« Reply #7 on: July 30, 2018, 03:38:40 AM »

Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to distribution.
 
Event Description
It was reported through clinic notes received on 8/21/2012 and dated (b)(6) 2012, that the patient had been fighting recurrent left axillary abscesses and had recently been put back on medications. No additional information is known.
 
Manufacturer Narrative

Event Description
The device manufacturing records for the implanted generator were reviewed and sterilization, prior to distribution was confirmed.
 
Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2750888
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dennis100
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« Reply #8 on: July 30, 2018, 03:39:28 AM »

Model Number 101
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient's active problems include abscess in the right breast, breast mass, and breast cancer. Follow up with the nurse found that there was no mention of a relation between these events and the vns. The patient's medical history of these events was unknown. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3476779
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« Reply #9 on: July 30, 2018, 03:40:15 AM »

Model Number 106
Device Problem No Known Device 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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dennis100
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« Reply #10 on: July 30, 2018, 03:41:02 AM »

Model Number 300-20
Event Date 03/18/2014
Event Type  Injury   
Event Description
The physician reported that a ct scan revealed fluid collection over the electrodes. The device was explanted removing a majority of the lead. It was reported that the patient was not reimplanted due to the infection. The patient subsequently developed an abscess and infection around his clavicle which was attributed to the patient¿s sepsis and pneumonia. No plans have been made for re-implant at this time. During the exploratory surgery high impedance was observed on system diagnostics. The high impedance was reported in mfr. Report # 1644487-2014-02015.
 
Event Description
It was reported that the patient developed a large bump above the lead incision site following generator replacement surgery. It was reported that the patient has a history of infection over the generator site. It was reported that the lead incision was not opened during the generator replacement surgery and the patient is scheduled for exploratory surgery to determine if an infection is present. Further follow-up revealed that exploratory surgery confirmed that an infection was present. It was reported that pneumonia and a history of sepsis may have contributed to the infection around the lead electrodes. The physician indicated there is no relationship of the mass to vns.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3983965
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« Reply #11 on: July 30, 2018, 03:41:50 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Patient identifier; corrected data: the previously submitted mdr did not provide the correct patient identifier. Describe event of problem; corrected data: the previously submitted mdr did not include information of the observed pitting.
 
Event Description
A lead explanted due to infection (mfr. Report #1644487-2014-02414) was returned and analyzed. Analysis of the lead was completed on (b)(4) 2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Abraded openings were found on the outer and inner tubing near the break locations, possibly caused by wear. A green substance was observed inside the outer silicone tubing in some areas. White deposits were observed on the outer and inner silicone tubes. Coding will be added for the lead fractures and fluid leaks. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence of multiple discontinuities in the negative coil of the returned portions of the device. Note that since portions of the (+) white and (-) green electrode quadfilar coils and the anchor tether were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Scanning electron microscopy identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The device issue reported here is related to the events reported in mfr report #1644487-2014-02414.

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« Reply #12 on: July 30, 2018, 03:42:24 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported that the pt was to have generator replacement surgery, but this has been cancelled for now due to the pt having a "chest abscess". No further info is available regarding the cause or nature of the abscess. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894920
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« Reply #13 on: July 30, 2018, 03:43:02 AM »

Model Number 302-20
Event Date 06/29/2004
Event Type  Malfunction   
Manufacturer Narrative
The negative coil has discoloration; scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the discolored region. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Additionally, review of the lead manufacturing records confirmed the lead met all final testing prior to distribution. Only a portion of the lead was returned for analysis which did reveal corrosion had occurred. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that during a planned vns generator replacement surgery for generator end of service, a lead fracture was noted just distal to the anchor tether along with infection at the lead site in the neck (pocket abscess). The infection is felt to be due to an indolent infection from the initial electrode implant surgery from (b)(6) 2004. Ongoing inflammation may have contributed to the lead fracture per the reporter. No patient manipulation or trauma occurred. Wound cultures were performed which were negative. No other interventions were performed other than explant surgery, and the patient is recovering satisfactorily from the infection. The explanted generator and lead were returned for analysis on (b)(4) 2013. No anomalies were noted with the generator analysis, and the generator performed per specifications. Only a portion of the lead was returned for analysis. Prior to decontamination, continuity measurements taken between the setscrew and the end of the lead portion attached to the pulse generator (¿as received¿) verified that proper electrical contact between the setscrew and the lead pin was present. The negative coil has discoloration. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the discolored region. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observation, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119298
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« Reply #14 on: July 30, 2018, 03:43:37 AM »

Model Number 302-20
Event Date 09/01/2010
Event Type  Malfunction   
Event Description
It was reported that high lead impedance (low/high/>10,000 ohms) was received at a f/u appt with the treating neurologist following a battery replacement. The pt underwent generator replacement surgery on (b)(6) 2010 due to battery depletion and high lead impedance was received on (b)(6) 2010 during system diagnostics. A company rep was present at the time the generator was replaced and indicated diagnostics and impedance were ok/ok/3, 408/10yrs outside the pocket and ok/ok/3,992/10 yrs inside the pocket. The surgeon took x-rays and indicated there was no lead break and pin looked fully inserted. F/u with a company rep revealed that the pt's device was disabled on (b)(6) 2010 by the treating nurse. No pt manipulation or trauma to the device were reported by the pt or mother. At the moment the pt is going for a second surgery in which the chest and neck area are being prepped to revise the device and change as needed. X-rays were taken but are likely not going to be released by the nurse. Additional info was received through clinic notes from the treating neurologist. The notes indicated that high lead impedance (ok/>10,000 ohms/high) was received following battery replacement. The pt's generator was replaced on (b)(6) 2010 and the high lead impedance was encountered on (b)(6) 2010. X-rays were taken and evaluated by the treating nurse who saw no obvious lead fracture. Moreover, the pt experienced pain over the vagal nerve stimulator which is directly below stitch abscess on incision line and stated the pain increased when lifting his arm laterally. A post-op note was received dated (b)(6) 2010 in which the note indicated the pt's generator was replaced due to end of service. A new generator was implanted and was checked to have proper function. Additional info was received from a company rep indicating he was present at the surgery and both outside the pocket and inside the pocket test were performed and were within normal limits. Moreover, the company rep indicated that the pt's pain was attributed to be due to surgery according to the neurologist. At the moment revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845861
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« Reply #15 on: July 30, 2018, 03:44:10 AM »

Model Number 304-20
Event Date 02/01/2013
Event Type  Injury   
Event Description
It was reported that the patient came in the er with an infection at the neck incision site. The patient was started on antibiotics. Later the patient reported to the physician that the lead was extruding. The surgeon believes that the patient was picking at the site might have cause the infection and the extrusion. The device history report (dhr) was reviewed and no unresolved non conformances were found. The vns lead was sterilized when shipped. Additional information was received stating that a possible stitch abscess was inciting the area and then picking by patient. The physician then confirmed that the patient's picking caused or contributed to the extrusion of the vns lead. Cultures were taken but were negative to infection. There were no medication or diet changes that could have contributed to the extrusion. Surgery is planned, and may have occurred but it has not been confirmed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient was explanted on (b)(6) 2013. The explanted products were discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026467
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« Reply #16 on: July 30, 2018, 03:44:52 AM »

Model Number 302-20
Event Date 08/22/2011
Event Type  Malfunction   
Event Description
It was reported that following the patient's recent implant procedure, high impedance was observed. No trauma or manipulation was suspected. A system diagnostic test reported a lead impedance of 8800 ohms. It was however confirmed that diagnostics within normal limits had been performed since the patient had been implanted. The patient was referred for surgery and, at that time, the patient's settings were increased because the physician felt that this would prevent the patient from losing stimulation. X-rays were taken and provided to the manufacturer for review. The generator placement appeared normal, in the left chest. The filter feedthru wires were intact and the lead pin was fully inserted into the header of the generator. The lead wires also appeared intact at the lead pin. The entire lead could not be seen in the x-ray images as a portion of the lead was located behind the generator. The electrodes appeared to be properly aligned and placed on the nerve. There did not appear to be any lead discontinuities or sharp angles in the visible portions of the lead body, however a fracture or micro-fracture cannot be ruled out. There did appear to be a suspect area following the tie-down in the neck, however due to image quality, no conclusions can be drawn on this area. Based on the x-ray received, the cause of the patient's high impedance could not be determined; however a fracture or micro-fracture in the suspect area or non-visible portion of the lead cannot be ruled out. The patient had surgery on (b)(6) 2011. During the procedure, pus was identified in the neck, surrounding the lead. The physician characterized this as a sterile abscess. Cultures were taken and gram stain was negative, indicating that there was no sign of an infection. In addition, the patient did not have a fever or external swelling at the site. The patient was completely explanted at that time. It was noted that during the explant procedure, a kink was observed in the patient's lead near the clavicle; however it is unknown if a break occurred in that area. Additional information was received indicating that the patient was re-implanted on (b)(6) 2011. The patient's generator has since been returned, however product analysis has not yet been completed. The lead will not be returned as it has been discarded.
 
Event Description
Product analysis has been completed on the explanted generator. Results of diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2278701
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« Reply #17 on: August 10, 2018, 03:51:58 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
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 stated in a fax from a physician that sepsis was found in an abscess near a patient's vns device after a recent battery replacement and that the device was explanted the next day. Device history records were reviewed for the device and it was indicated that the device was sterilized and passed all quality inspections prior to distribution. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709602
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« Reply #18 on: August 11, 2018, 12:55:08 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
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« Reply #19 on: August 17, 2018, 06:27:58 AM »

Model Number 302-20
Event Date 04/20/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that a vns pt had an mrsa infection in the neck and needed to have her leads explanted. The pt's generator has already been explanted since 2007. The surgeon reported that the pt went to see an ent physician because of an abscess in her neck. When the pt's generator was removed in 2007, the surgeon went up into the neck as far as possible and cut the lead, however a wire was left sticking out which caused the area to become infected with an abscess. They found out that the infection was mrsa and they decided to remove the leads. On (b)(6) 2011 the pt's lead was explanted. Attempts for product return will be made. According to the surgeon, the issue is now resolved. X-rays were taken prior to the pt's lead removal however a copy of them has not been sent to the mfr at this point. On (b)(6) 2011 the lead dhr was reviewed and all items were signed off prior to distribution. If add'l info is received, it will be reported.
 
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for the lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096032
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« Reply #20 on: August 17, 2018, 06:28:32 AM »

Model Number 302-20
Event Date 02/06/2008
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported through an adverse event form that a vns pt experienced abscess/swelling in the area of the vns lead. The event was said to be continuous and moderate in severity that was possibly related to implantation, but not to stimulation. The event was not present prior to implantation. Cultures were taken of the abscess and (b)(6) was found. The device was explanted, which resulted in the improvement of the pt (b)(6) 2008. Good faith attempts to obtain additional info are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098579
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« Reply #21 on: September 09, 2018, 01:08:25 AM »

Model Number 303-20
Event Date 08/03/2011
Event Type  Injury   
Event Description
It was initially reported that the patient was recently implanted and developed an infection. The patient had an abscess in her neck and had their generator and lead explanted due to the lump and abscess. Patient immune system is not good and they have a history of leukopenia and (b)(6). A hematologist cleared her for surgery prior to implant. The surgeon took the extra precautions. The patient had a hippa-cleanze the night prior to surgery and had vancomycin iv before the surgery. The implant site was flushed with antibiotics during implant and also explant. The surgeon decline to attempt to implant the patient again since this was the second attempt by him that ending in infections. The patient's previous generator was explanted due to an infection (b)(6). Good faith attempts for more information have been unsuccessful to date. Review of the manufacturing records confirms sterilization for both the generator and the lead prior to shipment.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial reported inadvertently place another number in place of the mdr number that was to be referenced. The correct mdr reference should have been 1644487-2011-01845.
 
Event Description
When additional information was received regarding the infection of the patient's second implant it was incorrectly reported under mdr 1644487-2011-01845, instead of this mdr number. Additional information was received that indicated the patient was re-implanted with a lead and generator after being explanted due to an infection.
 
Event Description
Additional information was received that indicated that there was no manipulation or trauma occurred that would contribute to the infection. It was unknown by the physician if cultures were taken. The correct mdr reference is 1644487-2011-01845.
 
Manufacturer Narrative
Describe event or problem, corrected data: when additional information was received regarding the infection of the patient's second implant it was incorrectly reported under mdr 1644487-2011-01845, instead of this mdr number.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2269431
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« Reply #22 on: September 21, 2018, 01:37:22 PM »

Model Number 103
Event Date 04/15/2012
Event Type  Injury  
Manufacturer Narrative
Date of event, corrected data: the correct event date is provided by the reporter. Operator of device, corrected data: the initial mdr report inadvertently listed the health professional as the operator of the device. The operator is the patient.
 
Event Description
It was initially reported that patient had their generator and lead explanted due to an infection. The generator and lead were returned to the manufacturer for evaluation on (b)(6) 2012. The exact date of the explant is not known. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had an abscess that developed on the chest at the generator site approximately (b)(6) 2012. There was no known trauma to the site. It was not felt the infection was related to the vns implant procedure, but it was not known what to attribute the infection to. The patient was started on antibiotics initially and cultures did not have any growth of organisms, and then surgery was performed on (b)(6) 2012. It was felt it was best for the patient to explant the vns. It is not certain if the patient will be reimplanted with the vns anytime soon. The patient has recovered from the infection. Analysis of the vns generator was completed. No anomalies were identified, and the generator performed per specifications. Analysis of the vns lead is pending.
 
Event Description
Product analysis was completed on the vns lead portion returned. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The electrode array was not returned.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2600096
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« Reply #23 on: September 21, 2018, 01:38:19 PM »

Model Number 102
Event Date 03/01/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient may have experienced some sort of an axillary infection in (b)(6) 2014 from poking and scratching at his device. The patient¿s device was reported to be functioning well at the time. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 reported that the patient had been treated for an ¿abscess¿ in the left axillae with an incision and drainage by his primary care physician on two occasions recently. The most recent was about a week and a half prior. The patient denied any antibiotic prescription given. The patient reported that it had returned somewhat. Upon physical examination, there was an approximate 1. 5 inch length palpable lesion in the left axillae which was soft but not mobile. There was no redness or skin breakdown. There was no tenderness to palpitation. The physician¿s assessment at that time was that the lesion may represent a sterile cyst versus infection abscess with the infection abscess less likely. Clinic notes dated (b)(6) 2014 reported that the patient had an axillary cyst which had since been drained and appeared to have improved at that point.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the generator device history records confirmed sterilization was performed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3882083
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« Reply #24 on: September 21, 2018, 01:39:15 PM »

Model Number 302-30
Event Date 03/25/2012
Event Type  Malfunction   
Event Description
It was reported that the patient was being referred for lead replacement due to high lead impedance. Follow-up with the neurologist found that the high impedance was first found on (b)(6) 2011. Diagnostics taken on (b)(6) 2011, were normal with an impedance value of 1429 ohms. No x-rays have been taken. No trauma or manipulation was noted, however it was indicated that the patient's cat 'kneads" in the area of the lead, but the physician does not believe this would have been enough to damage the lead. The replacement surgery was scheduled for (b)(6) 2012, however the lead and generator were explanted at that time instead. Information was later received indicating that the patient had developed an infection at the lead incision site and was the reason the lead and generator were not replaced. The infection was not believed to be related to a previous surgery. The patient was noted as having a blister that was believed to have developed into the infection. The infected area was described as "draining cysts" with pus in the noted area. The patient's pcp had noted the infection approximately one month prior to the explant surgery and had given the patient antibiotics which reportedly cleared the issue however the infection returned when the antibiotics were stopped. Cultures were taken at the time of surgery that showed no growth. The patient was noted as now doing fine. No trauma or manipulation is believed to have caused or contributed to the infection. The physician indicated that she believes the infection may have "stuck" to the lead. Further follow-up with the neurologist's office found the generator was not disabled when the high impedance was found as recommended in manufacturer labeling. If a lead fracture is present, corrosion of the lead could result in a foreign body response. Attempts for additional information and the return of the explanted lead and generator are in progress.
 
Event Description
Additional information was received indicating that per hospital policy, the explanted products will likely not be returned. Additional programming history was received indicating that the impedance value on (b)(6) 2012 was 7832 ohms.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Device failure is suspected.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585987
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« Reply #25 on: September 21, 2018, 01:40:37 PM »

Model Number 302-20
Event Date 09/03/2012
Event Type  Malfunction   
Event Description
Product analysis of the returned generator found no anomalies. The reported demipulse eos was not duplicated in the product analysis lab. Results of diagnostic testing indicated the device operated and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Product analysis on the returned portion of the explanted lead found a lead break and corrosion (electro-etching/pitting). It was noted that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector pin quadfilar coil appeared to be broken approximately 236mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as being thin which prevented identification of the coil fracture type with evidence of electro-etching and pitting on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations a lead break. Since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional information has been provided.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
An investigation was initiated in response to a trend in lead failure events noted with patient implanted with the original model 105 generator design ((b)(4)). The investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design ((b)(4)). As a result of this charge imbalance and the low pitting potential of mp35n quadfilar coil, coil corrosion can occur resulting in a lead discontinuity. Corrective action was taken by the manufacturer as a result of this investigation. The generator that the patient was implanted with when the lead break occurred was manufactured prior to the corrective action.
 
Event Description
Operative notes were received from the date of surgery. Date of surgery was notes to be (b)(6) 2012. There was no evidence of a seroma or other infectious process and the lead insertion appeared normal. Approximately 3-4 cm form the insertion into the generator there was seen to be a small tear in the insulation with fluid inside the tubing which the surgeon felt was the reason for the high impedance. A new generator was connected the lead and the high impedance was still present. The mass was determined to be a suture granuloma or perhaps an inflammatory lymph node from the patient¿s initial implant in 2005. There was no indication of an infection. The mass was determined to be a fibrous capsule of fibrous connective tissue with cystic area.
 
Event Description
Clinic notes dated (b)(6) 2013 were received in response to attempts for additional information; however, these notes did not have any information relevant to the reported events, except for the patient's programming and diagnostic history.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Upon a second review of the clinic notes, it does not appear that there is an allegation of the magnet not aborting seizures. The notes indicated "unresponsive 1 minute - magnet swipe. " in addition, the reported of the increase in seizures is not believed to be related to vns. The notes indicated that the increase is related to the patient's birth control pills.
 
Event Description
On (b)(6) 2012 the physician reported that the patient was seen in clinic that day and was found to have a lead impedance of greater than 10,000 ohms. The patient's vns was turned off and x-rays of the neck and chest were ordered. It is unknown if the x-rays will be sent to the company for review. There was no evidence of patient manipulation or trauma that could have caused or contributed to the high impedance. A review of clinic notes dated (b)(6) 2012 noted that the patient had been almost one year free without seizures, but had three seizures on (b)(6) 2012. The patient was stated to be unresponsive to magnet swipes. The patient underwent a lead replacement surgery on (b)(6) 2012. Additional information was received from the surgeon who stated that when explanting the lead he found what appeared to be a fracture in the area of the lead right above the generator site. When removing the helices off the nerve, the surgeon noted a granuloma that appeared to have sterile puss in it likely from the original implant. The surgeon stated that he does not feel the granuloma is an infection as the patient never had symptoms and the gram stain was negative. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880597
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« Reply #26 on: September 21, 2018, 01:43:23 PM »

Model Number 300-20
Event Date 04/01/2013
Event Type  Injury   
Event Description
Additional information was received that the patient had seen the surgeon without a referral from her treating physician. The surgery was cancels and is not currently planned.
 
Event Description
Additional information was received that the patient is going to have her generator and lead explanted. Surgery if likely but has not occurred to date.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient was experiencing painful stimulation. The patient has requested to be explanted due to the painful stimulation and possible lead protrusion in the neck. Information of the surgeon's office was that there did not seem to be anything wrong with the patient's vns and indicated that the patient may not be proceeding with surgery but this was not able to be confirmed. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Additional information was received which changes the product the report is reported on.
 
Event Description
On (b)(4) 2013 clinic notes were received dated (b)(6) 2013. The clinic notes mention that the patient has a ¿lump in her neck that another doctor had said that the wire is wrapped around¿. The patient stated that her pump has not worked since (b)(6) 2013; that it has been ¿two years since the wire broke¿. The clinic notes mention that the patient has visual hallucinations. The patient was referred for x-rays to check her lead. A copy of the ct of the neck soft tissue was received dated (b)(6) 2012 which indicates that ¿at the site where there was previously felt to be some skin thickening close to the site of the neurostimulator leads, there is still some skin thickening but no increase in the size of the vague density. The apparent sebaceous cyst seen more anteriorly is unchanged¿. It was stated that the patient had complained of a left neck lump and dysphagia. It was stated that this palpable lump is just inferior to the parotid gland but there is no identifiable mass at this site. Slightly anterior to this, there is a small skin lesion which was noted to might be a small sebaceous cyst. The ct scan sated that there is no mass in the region of the palpable lump. The patient underwent a generator replacement on (b)(6) 2013. The explanted generator has not been received for product analysis to date.
 
Event Description
It was reported that on (b)(6) 2013 the patient had a tumor removed from her neck.
 
Event Description
It was reported that the explanting facility discarded the explanted generator and it will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3116210
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« Reply #27 on: September 21, 2018, 01:44:20 PM »

Model Number 304-20
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Date: settings [output current (ma)/ frequency (hz)/ pulse width (microseconds)/ on time (seconds)/ off time (minutes)/ magnet output current (ma)/ magnet pulse width (microseconds)/ magnet on time (seconds)]; diagnostics: [(normal mode) output status/ lead impedance; (system mode) output status/ lead impedance/ impedance value/ end of service?] : (b)(6) 2012: 0. 5/30/500/30/5; 0. 75/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2012: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/3200ohms/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2762ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2712ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2887ohms/no; (b)(6) 2013: 1. 0/25/500/21/1. 9; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2867ohms/no.
 
Event Description
It was reported that the patient was diagnosed with vocal cord problem that the ent attributes to vns therapy. It was reported that the patient experiences some difficulty breathing as a result of the vocal cord problem. Clinic notes dated (b)(6) 2013, note that the ent confirmed that vns discharges appear to be affecting the left vocal cord function, which may be compromising respiration in the context of his right-sided cyst. It was reported that device diagnostics were within normal limits. The physician may try to adjust device settings and then send the patient back to ent for reevaluation. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3418880
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« Reply #28 on: September 21, 2018, 01:45:49 PM »

Device Problems Improper or Incorrect Procedure or Method; Material Protrusion / Extrusion
Event Date 11/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had developed a cyst/abscess at her neck incision site that ruptured causing the incision site to open. The lead was extruding from the patient¿s incision site and there were concerns that the patient may injure herself or damage the device. Surgical dressing was used to cover the wound but the patient kept picking it off. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 for wound debridement and to reclose the incision site. The patient continued to manipulate the incision site so the patient underwent surgery on (b)(6) 2014 to explant her device due to infection.
 
Event Description
Further information was received indicating that the patient had undergone a battery replacement on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325307
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« Reply #29 on: September 26, 2018, 05:32:52 AM »

Model Number 302-20
Event Date 01/24/2012
Event Type  Malfunction   
Event Description
It was reported that the patient underwent device explant in 2012; however, the exact date was unknown. It was reported that the patient had been referred for device reimplant. It was reported that the patient had a strange lump on his neck and was lost to follow-up for a while. Further follow-up revealed that the patient was scheduled for lead revision surgery in 2012; however, at the time of the surgery it was noted that the patient had a large lump on the right side of his neck and the surgery was cancelled. It was reported that the patient later underwent device explant and that the patient was not reimplanted due to the lump on the right side of his neck. The lump was a believed infection from a cranial surgery the patient underwent. It was reported that the infection was not related to vns therapy. It was reported that the patient is unreliable and was lost to follow-up. Clinic notes dated (b)(4) 2013 noted that the patient contracted (b)(6) in the hospital and had the vns system removed in (b)(6) 2012. It was noted that since then the patient's seizures have worsened in frequency and severity and that patient would like to discuss having a new vns system implanted. Analysis of the programming history showed that the generator was programmed off on (b)(6) 2012. Reimplant is likely; however, has not occurred to date.
 
Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient underwent surgery on (b)(6) 2012 and a large neck abscess was found. The abscess was drained and the generator and electrodes were removed with the exception of about 1 cm of the most distal electrode. Attempts to have the product returned for analysis have been unsuccessful to date.
 
Event Description
It was reported that the device was destroyed and will not be returned to manufacturer for analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had high impedance on a diagnostic test and recently had an increase in seizures. The patient was admitted to the er for the seizures on (b)(6) 2012. No manipulation or trauma was suspected and x-rays will not be performed. The device has not yet been programmed off. The patient has since been referred for surgery; however surgery has not occurred to date. No additional information was provided.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2464893
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« Reply #30 on: September 29, 2018, 03:55:17 AM »

Model Number 102
Event Date 01/07/2012
Event Type  Injury   
Manufacturer Narrative
Initial report inadvertently indicated the incorrect explant date.
 
Event Description
Additional information was received indicating that patient had an abscess at the generator site that caused the infection. The patient was noted as having fever and an altered mental state as a result of the abscess.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient's vns lead and generator were explanted due to an infection at the generator site. Follow-up with the neurologist and surgeon's office was made, however, no information was available except that cultures taken on (b)(6) 2012 indicated (b)(6). Review of the device history record for the lead and generator confirmed sterility prior to distribution.

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« Reply #31 on: October 11, 2018, 06:36:47 AM »

Device Problems Improper or Incorrect Procedure or Method; Material Protrusion / Extrusion
Event Date 11/13/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the vns patient had developed a cyst/abscess at her neck incision site that ruptured causing the incision site to open. The lead was extruding from the patient¿s incision site and there were concerns that the patient may injure herself or damage the device. Surgical dressing was used to cover the wound but the patient kept picking it off. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 for wound debridement and to reclose the incision site. The patient continued to manipulate the incision site so the patient underwent surgery on (b)(6) 2014 to explant her device due to infection.
 
Event Description
Further information was received indicating that the patient had undergone a battery replacement on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325307
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« Reply #32 on: October 19, 2018, 11:32:07 AM »

Event Date 05/03/2011
Event Type  Injury   
Event Description
It was reported by a physician's site that the pt had a chest site infection and would need a removal of his vns. Furthermore, the device apparently did not help the pt. Further information indicated that the pt had been seen on (b)(6) 2010 and there was no infection. The pt was then brought to the er on (b)(6) 2011 and had abscessed cellulitis above the vns in the left chest. The pt had been sent from an outlying hospital because of this infection. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115024
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« Reply #33 on: November 07, 2018, 02:10:57 AM »

Model Number 304-20
Event Date 10/03/2013
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and normal mode diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was not disabled following the high impedance observation. The patient¿s physician stated that the patient¿s lead likely cracked from the patient¿s seizures. A mass was noted on the patient¿s neck during an office visit on (b)(6) 2013. The patient¿s radiology exam stated that the sonographic findings were most consistent with a hematoma at the patient¿s left neck. An abscess was not expected based on the absence of fever, wbc count, and the overlying redness and swelling.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance was observed on (b)(6) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient has high lead impedance. The patient had a fall with seizures approximately 3 weeks ago striking her neck area and developed a hematoma in the neck. When her vns was checked, she was found to have high impedance. It was stated that the surgeon was treating the hematoma with cold and warm compresses but the hematoma did not go down. No x-rays were taken due to patient¿s ¿mr¿ (possibly mental retardation). Patient went to surgery on (b)(6) 2013 to have a full revision but when the surgeon opened the left neck he saw a huge hematoma that entwined the nerve including the part where the helices were. The surgeon said he would not implant another lead/generator on the left side because of the extensive hematoma. The surgeon then elected to place the lead and the generator on the right side due to the severe hematoma and resulting scar tissue on the left side. The explanted lead and generator have not been returned to the manufacturer for product analysis to date.

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« Reply #34 on: November 17, 2018, 04:40:52 AM »

Model Number 103
Event Date 03/29/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the vns patient's device was hanging out of the wound. It was reported that the patient had recently underwent generator replacement surgery. The patient was referred to surgeon. It was later reported that the patient had an infection that started at the lead site after the patient picked open the incision from generator replacement. It was reported that the patient picking at the incision has caused the generator to extrude. It was reported that the patient had a pustule that traveled up the lead. There appears to be a boil-looking abscess at the neck site. The patient underwent generator explant on (b)(6) 2013 due to the extrusion and infection. The lead was left in place and the surgeon debrided the chest wall and neck and performed cultures. The cultures found (b)(6) at time of explant. The surgeon indicated that the wound will be left open for a few days and will be packed with antibiotic dressing and the patient will be treated with oral antibiotics. A second set of cultures were obtained on (b)(6) 2013 which were negative. It was reported on (b)(6) 2013 that the patient was scheduled for explant of the lead due to infection. The patient was placed on iv vancomycin by infectious disease. The lead was explanted on (b)(6) 2013. Reimplant is planned at a later date.

Event Description
The generator analysis was completed on (b)(4) 2013. The diagnostic testing showed that the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081131
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« Reply #35 on: November 19, 2018, 08:05:59 AM »

Model Number 104
Event Date 03/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient underwent surgery to explant the remaining portion of the lead on (b)(6) 2013.

Event Description
It was reported that the patient's generator site was infected and that the patient was referred to surgery. It was reported that the patient was originally scheduled for "closure" surgery; however, the surgeon decided to do a generator replacement to be safe and that it was being considered to place the new generator on the patient's right chest area. It was reported that the surgeon was uncertain if the infection was due to surgery or the presence of the device. There was no trauma or manipulation that occurred; however, it was reported that the patient may have picked at the incision. Clinic notes dated (b)(6) 2013 indicated that the patient had an open wound on the chest and that the patient's father reported that the wound was still draining and that the neurologist recommends that the vns be moved to the right site to allow abscess on the left to heal. Clinic notes dated (b)(6) 2013 indicated that the chest abscess was excised on (b)(6) 2013 and that the patient's mother reported that the wound was draining yellow with some odor. Further follow-up revealed that the patient underwent explant on (b)(6) 2013. It was reported that the plan is to reimplant a vns system in 5-6 months after the wound heals. Both the generator and lead were returned to device manufacturer for analysis on (b)(4) 2013. Product analysis is underway; however, had not yet been completed to date. The patient's father reported on (b)(6) 2013 that he was in the hospital with the patient due to the infection. The father reported that he was under the impression that both generator and lead were explanted; however, the patient underwent a ct scan which showed that a portion of the lead was still implanted. The father reported that the patient's infection has spread to the patient's neck where the lead portion is still implanted. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Event description, corrected data:the mfr. Report 03 inadvertently reported that the surgery was to replace the remaing portion of the lead.

Event Description
It was reported that the patient underwent surgery to replace the remaining portion of the lead on (b)(6) 2013.

Event Description
Further follow-up revealed that the patient was explanted due to possible infection at the site of incision. Reimplant is planned when the patient has healed. The returned product form indicates the generator and lead were returned; however, the reason was not marked. The op note revealed that the patient has an open wound of the chest and is for repair of chest wound from vagal nerve stimulation hematoma and possible skin flap with removal of vagal nerve stimulation. The generator and lead were received into product analysis on (b)(6) 2013. Analysis of the generator indicated that the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead will be reported in mfr report # 1644487-2013-01235.

Event Description
Further follow-up revealed that the physician did not believe that the vns system was related to the infection. Cultures were taken at the hospital; however, the results were not known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3053763
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« Reply #36 on: December 04, 2018, 02:07:35 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported that she has a strong family history for breast cancer and that she has cysts in both of her breasts and drainage in the breast on the side the generator is implanted. The patient reported that she is having an mri of the breasts by the cancer center. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3311190
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« Reply #37 on: December 05, 2018, 01:30:01 AM »

Model Number 103
Device Problems Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material
Event Date 05/17/2012
Event Type  Injury   
Event Description
Review of the manufacturing records for the generator confirmed sterilization was performed prior to distribution.

Event Description
It was reported that the wound is currently being treated and that the patient will be considered for reimplant in approximately 6 months.

Event Description
It was reported that the patient is in referral to have vns re-implanted. No known surgery has occurred to-date. No additional relevant information has been received to-date.

Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

Event Description
Clinic notes dated (b)(6) 2013 were received and reviewed. The notes indicate that the patient had undergone an excision of a cystic lesion in the midline neck in (b)(6) 2012. Subsequently, the patient has developed what appeared to be recurring infections at the site of the previous excision. Per the notes, this has currently been replaced by a massive red granulation tissue with some "serious discharge". The physician notes that in the operative notes from the previous year, the previous physician mentions that he encountered the wire from the nerve stimulator close to the cyst site. The physician states that, per his evaluation, he suspects that the patient has some kind of low-grade infection involving the nerve stimulator and the wire leading from it. Per the notes, this is the reason the patient has this ongoing process. The patient's father was informed that this is not going to be resolved by a simple excision at the site of the granulation and that the foreign body will need to be removed completely to facilitate healing of the wound. The physician suspects that they will have to consider replacing the nerve stimulator only after the infection has completely resolved. Operation notes from the (b)(6) 2012 excision indicates the specimen consisted of a single un-oriented gray-tan portion of skin with underlying subcutaneous tissue. The diagnosis indicated benign skin and subcutaneous tissue with acute abscess, chronic inflammation, and fibrosis. No cyst lining was identified. The specimen stains were negative for infectious organisms. The patient's vns generator and lead were explanted on (b)(6) 2013. The explanted device will not be returned by the explanting facility. Review of the lead device history records confirmed sterilization was performed prior to distribution. An attempt was made for additional information; however, it was unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3286150
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« Reply #38 on: December 08, 2018, 02:18:12 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/12/2017
Event Type  Injury   
Event Description
It was reported that patient had a surgical procedure to drain a cyst located on the left side of patient's neck at the lead incision site. Surgeon believed that the cyst was related to the presence of a lead tie-down. The surgeon indicated that the draining procedure was performed to preclude serious injury. Patient's cyst had serious fluid. No further relevant information has been received to date.

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« Reply #39 on: December 15, 2018, 02:33:04 AM »

Model Number 105
Event Date 07/15/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient experienced an infection shortly after implant. The patient was given antibiotics and then the infection would subside, but would flare up again after the antibiotics were discontinued. It was reported that this was a continuous process until the surgeon felt that the generator needed to be removed to help heal the site. It was reported that the chest area had erythema on (b)(6) 2013. The patient was given a 10 day course of keflex. The patient also received two 3 day courses of keflex (one in (b)(6) after the initial 10 day course had ended and one in the beginning of (b)(6)) for dental reason. On (b)(6) 2013 the patient was seen and put on 2 weeks of keflex for left chest incision abcess. On (b)(6) 2013 the patient was seen in the office with open neck and chest incision with drainage. The physician reported that the patient's lead could be seen coming through the neck. The patient underwent explant on (b)(6) 2013. The patient was discharge on antibiotics. It was reported that the cause of the infection is unknown. No patient manipulation or trauma occurred that could have caused or contributed to the infection. Cultures were positive for staph aureus. It was reported that reimplant will occur after the patient had a few more months to heal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425741
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« Reply #40 on: December 19, 2018, 12:49:06 PM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Clinic notes dated (b)(6) 2013, indicate the patient was seen back that day "poset" chess abscess at the vns pocket. The patient is doing well and shows no signs of infection. Sutures were removed. Clinic notes dated (b)(6) 2013 indicate that there were complications with the vns implant surgery which led to the infection. The infection required vns removal. An analysis was performed on the returned lead portions. The slice mark found on the outer silicone most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 924 volts (not at ifi), as measured during completion of test parameter (b)(4) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 1. 412% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
It was reported that the patient was going to undergo explant of the vns system on (b)(6) 2013 due to infection. It was reported that the patient has been on antibiotics. Further follow-up revealed that the patient was admitted to the hospital for iv antibiotic therapy and did not respond as well as the surgeon preferred. Clinic notes dated (b)(6) 2013 indicated that the patient had a right chest abscess with cellulitis. It was noted that the patient was doing well until 3 days prior when he noticed that his chest area became red and swollen and tender to touch. The patient was seen in the emergency room on (b)(6) 2013 and was found to have pus draining from the chest site. The patient was given antibiotics and sent home. The patient was seen by the physician on (b)(6) 2013 and a culture and sensitivity and gram stain were obtained. The gram strain was negative and the patient was admitted to the hospital for further antibiotic therapy. It was noted that the patient had bloody material draining from the wound at the anterior axilla region. The generator and lead were returned for analysis on 11/05/2013. Analysis is underway, but has not been completed to date.

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« Reply #41 on: January 06, 2019, 11:08:44 AM »

Model Number 303-20
Event Date 12/01/2012
Event Type  Injury   
Event Description
In the (b)(6) 2013 operative notes for the debridement of the wound and removal of tie-downs, it was noted that the patient's mother reported the mass appeared about three weeks prior to clinic visit. The surgeon noted that intra-operative findings were most likely consistent with granulation tissue overlying a superficially displaced tie-down tab and excess connecting lead. It had worked its way up and was toward the incision site and was much more superficial. This felt to likely be the consequence of the fact that the patient was continuously moving her head back and forth, side to side, and in flexion and extension. The surgeon felt this probably helped to dislodge the lead and cause it to migrate with it tie-down tabs.
 
Event Description
Clinic notes dated (b)(6) 2013 note that the physician has seen kids who have prominent tie downs that have eroded through the skin and resulted in infection. The physician reported that the vns patient did not experience erosion, but had an abcess that was inflamed and swollen and was inflamed over the protruding tie downs. It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the infection. It was reported that cultures were taken and found to be mrsa. The patient underwent debridement of the wound and two tie-downs were removed. The granulation tissue was removed and the patient was treated with prolonged iv antibiotics. It was noted that the device was functioning properly at the close of the surgery. The other two patient's with protruding tie downs were reported in mfr. Report #s: 1644487-2012-02492; 1644487-2014-00445.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
(b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632539
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« Reply #42 on: January 09, 2019, 09:03:23 AM »

Model Number 104
Event Date 11/26/2013
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently did not report this information.
 
Event Description
Analysis of the returned lead portion will be captured in manufacturer report # 1644487-2014-00993.
 
Event Description
In addition to the redness and swelling in the neck, there was whiteness and fluid collection under the skin which the treating physician thought to be a potential ¿abscess¿ at the electrode site.
 
Event Description
It was reported that the patient presented with a possible hematoma. It was reported that the patient had presented with a potential infection at the generator site following generator replacement surgery. The physician reported that the patient suffered a fall and hit the generator site after generator replacement surgery. The patient was seen by the physician and the location was swollen and reddened. The site began to improve and then began to enlarge again and was warm to the touch so the surgeon started antibiotics. It was reported that the patient's mother indicated that the patient had been picking at the surgical site. The physician reported that the patient developed a new area of redness and swelling in her neck. There appeared to be about 2-3 cm of collection under the skin. The patient was referred to the emergency departement and was admitted to the hospital. It was later reported that the patient was explanted due to infection. A new system was not implanted at this time. The generator and lead were received for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677747
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« Reply #43 on: January 15, 2019, 03:13:20 AM »

Model Number 103
Event Date 04/01/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient¿s infection was still present.
 
Manufacturer Narrative

Event Description
It was reported that the patient's lead was extruding around the generator site. It was reported that the patient was picking at the wound and that there was an abscess in the area where she was picking. The patient was at the emergency room and the physician planned to attempt to treat without explanting the device. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3815771
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« Reply #44 on: January 19, 2019, 03:32:44 AM »

Model Number 303-20
Event Date 04/14/2014
Event Type  Injury   
Event Description
It was reported that the vns patient had an open wound at his neck incision site. Granulation tissue was observed eight months after implant and the open wound was first observed on (b)(6) 2014. The surgeon stated that there was no obvious reason for the granulation tissue. Debridement of the granulation tissue was performed. The surgeon stated that trauma possibly had caused or contributed to the event as the patient had seizures and hit the affected areas. No causal or contributor medication changes preceded the onset of the event. Further follow-up revealed that the patient was given antibiotics and the patient¿s issues resolved. The patient¿s issues came back and the surgeon stated that the device needed to be explanted due to abscesses at the lead site. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received stating that the vns patient developed another pustule at his neck incision site. The surgeon previously packed the wound and the granulation tissue appeared to resolve by (b)(6) 2014. However, granulation tissue was noted at the same site during an office visit on (b)(6) 2014. The surgeon speculated that an infection had developed or the patient¿s body was rejecting the device. Cultures showed moderate staph. The patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
On (b)(6) 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 995 volts (not at ifi), as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Product analysis on the lead was completed on (b)(6) 2014. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3864292
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« Reply #45 on: January 21, 2019, 11:32:21 AM »

Model Number 302-20
Event Date 04/25/2008
Event Type  Malfunction   
Event Description
Mfr received pa and lateral chest and left neck x-rays from the treating physician to review the integrity of the lead. The physicians notes regarding the x-rays stated that there was no lead breaks observed and the sys appeared intact. Review of x-rays by the mfr revealed no obvious lead discontinuities or anomalies. The lead pin was fully inserted in to the generator, but was not able to be visualized past the connector block. Further follow up with the treating physician revealed that the pt had surgery recently to remove cysts on the posterior neck region, and that the pt has lennox-gastaut syndrome, static encephalopathy, and medically intractable epilepsy. Additionally, it was noted at a recent follow up visit, a sys diagnostic test revealed high lead impedance. Attempts to obtain add'l info from the treating physician are underway. Revision surgery is likely.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions - device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059781
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« Reply #46 on: January 27, 2019, 09:56:16 AM »

Model Number 103
Event Date 02/01/2014
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic explant of the vns system. It was reported that the patient fell down and the system was exposed; therefore, the patient underwent device explant. No additional relevant information has been received to date. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr inadvertently did not update the event date. This report is being submitted to correct this information. Age at time of event, corrected data: this field is being updated as the event date is updated. This report is being submitted to correct this information. If explanted, give date (mo/day/yr), corrected data: previously submitted mdr inadvertently did not update the explant date. This report is being submitted to correct this information.
 
Manufacturer Narrative
Method: device manufacturing records were reviewed. A review of device history records showed that both the lead and generator were sterilized prior to distribution.
 
Manufacturer Narrative

Event Description
The explanted generator and lead were received for analysis. The returned product form indicated that the patient came to the center to present abscess in left pectoral region (site location of the vagal stimulator battery) with exposed lead and purulent secretions, meriting removal of the device in addition to the electrodes due to the presence of purulent secretions in the adjacent area. Analysis of the lead was completed on 11/04/2014. Te that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on 11/05/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4054656
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« Reply #47 on: January 28, 2019, 06:02:14 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Analysis of the lead was completed on 09/22/2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Mfr. Report # 1644487-2014-02711 will house the lead analysis. Analysis of the generator was completed on 09/25/2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.
 
Event Description
It was reported that the patient underwent an incision and drainage of a left scapular abcess and complete removal of the vns system. Both lead and generator were explanted. The explanted devices were returned for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103311
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« Reply #48 on: February 01, 2019, 12:11:35 PM »

Model Number 105
Event Date 06/11/2014
Event Type  Injury   
Event Description
It was reported that the vns patient developed an abscess at his generator incision site following generator replacement surgery on (b)(6) 2014. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4193989
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« Reply #49 on: February 03, 2019, 03:58:33 PM »

Model Number 103
Event Date 08/14/2014
Event Type  Injury   
Manufacturer Narrative
This information was inadvertently left off of supplemental mfr. Report #01.
 
Event Description
Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
It was reported that there were no signs of infection, the patient had multiple er visits. The chest x-ray that was performed was normal. The patient never returned to the clinic for follow up. The vns was interrogated, results were not provided.
 
Manufacturer Narrative

Event Description
It was reported that the patient has a possible abscess at the generator site. The patient had recently undergone generator replacement. X-rays were performed. It was reported that after the post-op swelling went down a knot the size of a golf ball formed. It was reported that device diagnostics were within normal limits. No additional relevant information has been received to date. No known surgical interventions has been performed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4133500
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« Reply #50 on: February 08, 2019, 01:01:08 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via social media that the vns caused the patient to have cysts on her thyroid and that the vns put a lot of pressure on her voice box and thyroid. She reported that she had her thyroid removed a month prior. The vns was explanted due to unrelated reasons prior to the thyroid removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8294394
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« Reply #51 on: February 09, 2019, 02:29:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/26/2018
Event Type  Injury   
Event Description
It was reported that a patient had an open wound as the patient had a cyst that popped and the vns generator was now exposed. The patient was prescribed antibiotics for the wound. An update was received that the patient's generator and 90% of the lead were explanted. Attempts were made for further information, and clinic notes were received from the physician's office. Per the received clinic notes, it was confirmed that the patient had infection at the vns site and that the device was partially exposed due to the burst cyst. The vns was fully explanted and the patient was being treated for infection with antibiotics. No further assessments of the cause of the cyst or infection were provided from the notes. Device history records were reviewed for the devices, and it was confirmed that the devices were sterilized prior to distribution. No additional 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8264572
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« Reply #52 on: February 20, 2019, 12:03:22 PM »

Model Number 103
Event Date 01/27/2015
Event Type  Injury   
Event Description
It was reported that the vns patient developed an infection at the generator site following generator replacement surgery on (b)(6) 2015 due to low battery. The generator site was found to be swollen, red, and oozy during an office visit on (b)(6) 2015. The patient was subsequently given antibiotics and the infection later resolved. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Clinic notes were subsequently received indicating that the patient experienced a post-operative infection (left chest)/incisional abscess at the site of the vagal nerve stimulator pocket on (b)(6) 2015. It was described that unspecified conservative therapy had been attempted but was unsuccessful. The patient underwent incision, drainage and debridement of the left chest wall incision on (b)(6) 2015. It was stated that a wound vac was placed and the patient was treated long-term with antibiotics. The wound vac was discontinued at a later date and antibiotic treatment was continued.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4719619
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« Reply #53 on: March 13, 2019, 01:35:28 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2015
Event Type  Injury   
Event Description
It was reported that the vns patient had a "grape-sized cyst" at the generator site. Follow-up revealed that surgical removal of the cyst would be performed when the patient's device needed to be replaced. It was noted that the patient's device needed to be replaced soon. No known surgical interventions have occurred to date. A battery life calculation using the available programming history showed approximately 3. 1 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the patient's device had to be replaced soon as the device was programmed to a high duty cycle which drained the battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5057289
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« Reply #54 on: March 13, 2019, 01:37:33 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 08/07/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had experienced wound dehiscence at the electrode incision site due to manipulation. The patient received medical intervention. The area was drained and a new suture was performed. The physician did not see any evidence of an infection, but did prescribe antibiotics. The physician believed that the patient's caregiver applied pressure to the incision during bathing, which caused the wound to open.
 
Event Description
It was reported that the physician performed drainage of an abscess on (b)(6) 2015. He then decided to remove the entire vns system due to infection with secretion at the generator site. The patient was not hospitalized for this procedure. The cause of the infection was probably due to the mother of the patient cleaning the incision site roughly with some contaminated product or bacteria on the skin. The infection was located at both the generator and incision sites. No culture results were available, but the physician indicated that there were signs of infection. A review of the device history records showed that the generator and lead were sterilized prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5059042
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« Reply #55 on: March 23, 2019, 01:14:56 AM »

Model Number 106
Event Date 09/14/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2015 that the patient is having an explant due to infection on (b)(6) 2015. The design history record was reviewed for the generator was reviewed on (b)(6) 2015. The generator was confirmed to have been hp sterilized prior to distribution into the field. The generator and leads were explanted on (b)(6) 2015. The leads were clipped as high as they could be. On (b)(6) 2015 it was reported that the patient has a neck abscess so the surgeon is going to remove the rest of the lead and drain the abscess.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5293076
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« Reply #56 on: March 26, 2019, 02:20:40 AM »

Model Number 106
Event Date 12/02/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient may have developed an infection from vns surgery, because there was redness over the generator site. The patient also had an abscess along the suture at the generator incision site. The physician prescribed antibiotics for the infection. No cultures were taken, and no further intervention was planned at that time. The device history record for the generator was reviewed, and the generator was sterilized prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5357938
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« Reply #57 on: April 09, 2019, 12:42:17 AM »

Model Number 106
Event Date 06/13/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016. The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible. The patient's device was then explanted. The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release. The operative report was received from the explanting facility. The patient's wound swelled over the course of a few days and dehisced. The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection. A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well. No further relevant information has been received to date.
 
Event Description
It was reported that the patient started having redness and swelling at the left neck. The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead. The physician aspirated fluid from the cyst, which was dirty; and looked infected. The patient then had the remainder of the lead explanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493
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« Reply #58 on: April 21, 2019, 03:45:31 AM »

Model Number 102
Event Date 10/01/2016
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the patient's following physician was unwilling to increase device settings because of redness over the generator site. It was suspected that the redness represented an infection. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up with the treating neurologist showed that the patient was seen by their office in both (b)(6) 2016. The dates of the appointments were before the patient¿s caregiver reported the alleged infection to the manufacturer. The generator site appeared shifted, raised, and red. However, their office did not have any indication of interventions. The surgeon was stated as to not see it as necessary to intervene by moving the generator. Communications with the office of the surgeon showed the patient was seen in (b)(6) for a post-implant surgery evaluation between the two neurologist office visits. The surgeon has noted that the battery had moved inferiorly, but did not note any kind of infection or site reaction. The surgeon also commented that the wound appeared to be healing well, and there was no consideration of performing interventions at that time.
 
Event Description
Clinic notes were received indicating surgery to drain the cyst occurred. It was provided the patient has had more than one infection at the vns battery and lead sites. The physician provided that the infection was coming from the vns lead. The explanted remains of the lead and the generator were removed. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator and lead. The generator performed according to functional specifications and no abnormal performance or any other type of adverse condition was found. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6097070
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« Reply #59 on: April 26, 2019, 06:43:21 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2016
Event Type  Injury   
Event Description
It was reported that the patient was admitted for a possible infected generator site. The patient was planned to undergo imaging to determine the severity of the issue. The patient¿s generator was later removed due to an abscess in the chest. A review of device history records showed that the generator implanted in the previous generator replacement surgery was sterilized prior to distribution. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Communication with the office of the surgeon showed that at least part of the lead was removed in the surgery to explant the generator. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252944
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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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« 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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« 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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« 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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« 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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« 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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« 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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« 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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