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dennis100
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« Reply #2910 on: March 20, 2019, 11:06:57 AM »

Model Number 304-20
Device Problems Extrusion; Lead
Event Date 10/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had inflammation and lead extrusion at the neck incision about six weeks after implant surgery. There was no indication of an infection. The physician did not know the cause of the inflammation or lead extrusion since the wound had been healing well after the implant surgery. On (b)(6) 2015, the lead was reinserted into the neck without the nerve and electrodes being touched during the procedure, and the incision was closed. The incision was reported to be healing well after the surgery.
 
Event Description
It was reported that an infection was present at the generator and lead sites on (b)(6) 2015. Infected skin necrosis on the left chest wall was found, and an open wound was visible with drainage. The generator and lead were explanted on (b)(6) 2015. The infection appeared spontaneously and was not attributed to patient manipulation. The physician plans to re-implant the patient with a new vns system in 3 months, because the patient responded well to therapy. The device history records for the generator and lead were reviewed, and both were sterilized prior to distribution. Attempts for additional information were unsuccessful to date.
 
Event Description
The physician believed that the cause of the infection was that the patient developed a seroma at the generator site 4 weeks post-op. Cultures were taken, and the result was staphylococcus aureus with multiple sensitivities (not (b)(6)).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224608
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« Reply #2911 on: March 21, 2019, 01:20:20 AM »

Model Number 106
Device Problem Human-Device Interface Problem
Event Date 10/07/2015
Event Type  Injury   
Event Description
It was originally reported by the physician the patient had a large infection at the generator site. The patient's lead and generator were explanted and the surgeon noted dehiscence caused by the patient smoking, and not infection. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The generator is expected to be returned for analysis; however, analysis is not relevant to the wound dehiscence as the dehiscence was reported to be due to the patient's smoking. Product analysis, if the generator is received, will be reported in mfr. Report # 1644487-2015-05824.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted lead was returned for analysis. It should be noted that only approximately 15cm of the lead was returned, not including the electrode array; therefore, an evaluation could not be performed on the entire lead. Setscrew marks were seen on the connector pin, providing evidence that, at one point in time, proper contact between the setscrew and the lead pin existed. Other than typical wear and explant related observations, no anomalies were identified in the returned portion of the lead. No other additional relevant information has been received to date.
 
Event Description
A vns implant card was received indicating the patient had been re-implanted with a new vns generator and lead on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5201164
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dennis100
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« Reply #2912 on: April 05, 2019, 10:01:32 PM »

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¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064
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dennis100
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« Reply #2913 on: April 05, 2019, 10:02:10 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had their generator and lead explanted due to an infection. It was reported that the patient had picked at the generator site. A review of the device history records showed that the implanted generator and lead were sterilized prior to distribution. The generator and lead passed all quality tests prior to distribution. Device evaluation is not necessary as the reported event of the infection is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8450152
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« Reply #2914 on: April 05, 2019, 10:02:48 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient presented with an open wound with generator exposure on the patient¿s left side/chest. The wound was caused by a surgical site infection after device implant. The patient underwent a surgical procedure on (b)(6) 2019. The procedure was noted to be successful and the vns system remained in the patient¿s body with ok impedance. Further information was received that the patient had to go to the operation room to close the open wound and the patient has since been discharged from the hospital. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458088
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dennis100
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« Reply #2915 on: April 05, 2019, 10:03:27 PM »

Model Number 106
Device Problem Corroded
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle. The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site. The patient was admitted to the hospital and given antibiotics. The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out. It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. The explanted suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
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« Reply #2916 on: April 05, 2019, 10:04:04 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2018
Event Type  Injury   
Event Description
Article titled "improved quality of life and cognition after early vagal nerve stimulator implantation in children" was reviewed and three adverse events were identified for the patients studied within the cohort. 3 of the patients developed infections post implant and 1 of those patients required revision surgery due to the infection. 1 patient passed away prior to the study (captured in mfr. Report # 1644487-2019-00452) 1 patient had disconnection of their electrodes from the vagus nerve that required revision surgery(captured in mfr. Report # 1644487-2019-00454). It was reported that there was no permanent morbidity due to these events. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404598
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dennis100
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« Reply #2917 on: April 05, 2019, 10:04:41 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/22/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient had an incision and drainage procedure with chest would debridement. The vns generator site was infected with green drainage and wires and hardware from the vns were exposed. Device history records were reviewed for the generator. The device was sterilized and passed all specifications prior to distribution. The patient¿s infection was believed to be related to a previous infection, reported in mfr. Report 1644487-2018-01176. This infection is being reported separately as it occurred on a new generator. Information was received that the patient was continuing to reopen his wound. The patient had the sutures removed, and the wound had reopened. The patient was doing well and the site was clean with no drainage. The patient is on antibiotics. 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 additional surgical intervention has 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=8449326
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« Reply #2918 on: April 05, 2019, 10:05:25 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was originally reported in mfr report # 1644487-2018-01588 that a patient had an infection. Additional information was received that the infection was at the generator site and unrelated to the events in mfr report # 1644487-2018-01588 therefore all information regarding the generator infection will be housed in this report. The patient had a revision then was prescribed antibiotics and eventually had a full explant. The recent infection was not a continuation of the patient¿s past extrusion event and that the location of the patient¿s infection was at the generator site. The physician¿s assessment on the cause of the infection was that it was due to persistent protrusion of the battery. Device history records indicated both devices were confirmed to be hp sterilized prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444571
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« Reply #2919 on: April 06, 2019, 02:22:03 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/15/2019
Event Type  Injury   
Event Description
A patient was seen in the office and it was observed that the generator had extruded and needed replacement. The patient was going to see the surgeon as soon as possible. It was stated that the physician did not know the cause of the extrusion and that the device was explanted due to infection. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458805
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« Reply #2920 on: April 07, 2019, 03:12:37 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient had an infection over the lead. The physician performed a wash out and re-closure procedure. Information from the surgeon¿s office indicated that the patient had previously had two wash out procedures for this infection on (b)(6) 2018 and (b)(6) 2019. The patient had been implanted on (b)(6) 2018. There were no obvious reasons for the patient¿s infection. The patient had multiple co-morbidities that may have influenced the infection. Device history records were reviewed for the generator and lead. The devices were sterilized prior to distribution, and passed all specifications. 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=8441174
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dennis100
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« Reply #2921 on: April 07, 2019, 03:13:08 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/02/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had their generator and leads explanted due to a staph infection. Device history records were reviewed for the generator and lead and both were confirmed to have been sterilized and passed all functional specifications prior to distribution. Device return and evaluation is not needed as the event is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8443388
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« Reply #2922 on: April 07, 2019, 03:13:50 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's incision had opened and that there was pus draining from the open incision. It was also reported that the patient's generator was visible. It was reported by the neurologist's office that the physician was unable to assess what caused the extrusion as it could have been related to manipulation, the infection, or inadequate wound healing. The patient's generator was explanted and their leads were clipped due to the infection. 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. No further relevant information has been received to date. Product return and device evaluation are not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439540
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« Reply #2923 on: April 08, 2019, 02:48:55 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2019
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 that a patient's generator was replaced due to a tissue infection. It was reported that the infection was located at the generator site and that the patient presented with the infection a week before the replacement surgery, despite having had their generator implanted approximately ten months prior. It was reported that the physician believed the cause of the infection was the patient's poor hygiene or wound contamination. A review of device history records for the generator show that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8383006
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« Reply #2924 on: April 08, 2019, 02:49:48 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/11/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was having vns explanted due to incision on his chest breaking open, exposing the vns. The patient continues to pick at the incision site. The patient is autistic and requires 24 hour supervision. The physician plans to explant the lead as well due to risk of infection. The patient¿s vns generator was recently implanted. Device history record for the generator and lead showed that both devices were hp sterilized prior to distribution into the field. The devices were explanted. It was noted that the generator was exposed, system was removed, cultures were taken and revealed (b)(6) post-op and the patient was put on antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439742
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« Reply #2925 on: April 08, 2019, 02:50:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/13/2019
Event Type  Injury   
Event Description
It was reported that a patient who has a model 106 that was implanted in (b)(6) 2018 has an infection and the device is scheduled to be removed. Device history records for the lead and generator were reviewed and both devices were confirmed to have been hp sterilized prior to distribution. No additional or relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404249
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« Reply #2926 on: April 08, 2019, 02:52:02 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient has a wound infection of the left axilla. Additional information was received that the patient first presented with the infection with an aching in their left axilla. The majority of the infection was located at the wound site, but the physician thinks the infection expanded to the generator area, but the wound site was not open. It was stated that this patient has diabetes with poor glycemic control, and therefore is at increased susceptibility to infection. Therefore the physician thinks the bacteria might be penetrated from the wound site at the left axilla and expanded to the generator area. 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. No known surgical intervention has occurred to date. No further relevant information has been received to date. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424229
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« Reply #2927 on: April 10, 2019, 01:35:01 AM »

Event Type  Injury   
Event Description
An article titled ¿vagus nerve stimulation for intractable epilepsy: a retrospective bicentric cohort study of 101 patients operated on between 1999 and 2010¿ was published on 01/29/2016 which included adverse events involving 4 vns patients. One patient underwent vns explant surgery due to ¿intolerance¿. Two patients presented infection. The patients underwent explant of the vns system due to the infection. One patient had his/her vns device disabled due to side effects. No known surgical interventions for the treatment of the patient have occurred to date. Attempts to obtain additional information were unsuccessful to date. This manufacturer report captures the patient 1 who presented infection and underwent explant surgery. Manufacturer report # 1644487-2016-01614 involves the patient who underwent vns explant surgery due to ¿intolerance¿. Manufacturer report # 1644487-2016-01616 involves the patient 2 who presented infection and underwent explant surgery. Manufacturer report # 1644487-2016-01617 involves the patient who had his/her vns device disabled due to side effects.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5802159
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« Reply #2928 on: April 16, 2019, 12:59:28 AM »

Model Number 106
Event Date 06/23/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an infection at the generator incision site following vns placement surgery. The patient was prescribed antibiotics and the infection resolved. The physician did not suspect that patient manipulation or trauma contributed to the infection. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5973066
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« Reply #2929 on: April 24, 2019, 02:22:20 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/17/2017
Event Type  Injury   
Event Description
It was reported that a vns patient had a retained suture, and was referred for surgery to revise the incision and remove the suture. The skin over the subcutaneous anchor was thinning and surgery was scheduled to prevent skin breakdown. Follow-up from the company representative who attended the surgery provided that a stitch through one of the tie downs was placed too shallow for such a small patient and had worked through the skin. There was no issue with the lead or any of the anchors. The stitch was removed and the tie-down cleaned up from some infection. Review of the manufacturing records confirmed the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Date of event, corrected data: the date of event was inadvertently provided incorrectly on the initial mdr.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6957232
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« Reply #2930 on: May 01, 2019, 01:00:22 AM »

Model Number 302-20
Device Problems Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's generator incision had approximately a 1 cm opening. The patient was taken to surgery to where the incision cleaned and closed. The generator was left implanted. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. It was noted that a few months prior to this report the generator had been repositioned due to infection. This event was reported in mfg report #1644487-2016-02673 however with the information available it does not appear that the current dehiscence wound is related to the previous infection. No additional relevant information has been received to date.
 
Event Description
It was reported that the generator pocket began filling up with fluid shortly after surgery that addressed the dehiscence wound. The fluid appeared to be building up behind the generator and the generator appeared to be "floating" in the pocket due the fluid. The patient was referred for surgery to drain the pocket and explant the generator. During the operation the surgeon observed that there was fluid inside the lead. Diagnostic testing was performed prior to surgery and there were no issues observed with the lead impedance. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2016-02673. Manufacturing records were reviewed for the lead it was confirmed that the lead was sterilized prior to distribution. The lead and generator were both explanted at that time. Historically, the explanting facility does not return explanted products to manufacturers. Therefore product return is not expected. This report will continue to capture the fluid leaks in the lead and dehiscence wound events while g report #1644487-2016-02673 will capture the initial infection that occurred after the generator replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6324817
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« Reply #2931 on: May 08, 2019, 10:34:03 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/12/2013
Event Type  Death   
Event Description
It was reported through an identified online obituary that the patient passed away. The patient died in a hospital, but no information was provided on the cause or other circumstances of death the generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution. Follow up with the servicing funeral home showed that per their process, the device was explanted since they screen for medical devices, but no specific record was present. They also reportedly discard of explanted devices. No additional pertinent information has been received to date.
 
Event Description
Communication from the hospital treating the patient at her time of death showed that the primary cause of death was listed as complications of bacterial meningitis. Contributing factors were cardiac arrest and severe cerebral edema, subarachnoid hemorrhage, and intracerebral hemorrhage. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6379640
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« Reply #2932 on: May 11, 2019, 02:29:29 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an infection, which led to the removal of their vns generator and a wound debridement. The patient's neurologist indicated that the reason for the generator pocket infection was unknown. It was reported that prior to generator explant, the generator was visible, likely due to the infection per the physician, and that the patient had a history of wound dehiscence, generator migration, and erosion through the skin. The patient's leads were initially left and the patient was treated with iv antibiotics for 10 weeks. The patient was hospitalized due to worsening condition of the neck area, that had began to drain due to infection, and the lead was infected and extruding through the skin as well. The patient additionally had a red "pimple-sized" bump at their neck incision site where the lead was coming through. The patient then had their vns leads removed on (b)(6) 2018 due to the reported infection and foreign body response. The patient had discomfort at their neck due to the reported lead extrusion. The patient had their vns electrodes removed on (b)(6) 2019 due to the infection, foreign body response, and discomfort at neck caused by the presence of the electrodes. A review of the device history records verified that the implanted products were sterilized and passed all functional specifications prior to distribution. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506142
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« Reply #2933 on: May 11, 2019, 02:30:11 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient had an infection on his neck incision after a patient's first implant and was given antibiotics. At the patient's dosing appointment, the physician still turned up the patient's generator to 0. 25ma, which the patient was tolerating well. It was stated that the patient had started taking antibiotics since the day after surgery, and that per the physician, the neck incision infection is healing well. It was further noted that the patient had a respiratory infection and still had a cough. Device history records were reviewed and showed that the implanted devices were sterilized prior to distribution. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8485770
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dennis100
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« Reply #2934 on: May 11, 2019, 02:31:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
An implant card was received for a patient¿s full system re-implant surgery. The patient had been explanted due to a serious infection requiring debridement and antibiotics. The patient had stayed outside and went camping with their family, and would scratch at the site. Additionally, the patient has gddt immunodeficiency. The device history records were reviewed for the generator and lead. The devices were sterilized prior to distribution, and there were no unresolved non-conformances. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514464
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dennis100
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« Reply #2935 on: May 14, 2019, 01:16:08 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
(b)(4). Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient reported that she became infected after a replacement surgery in 2015, which led to the need to have device explanted and re-implanted in 2015. The surgeon from the patient¿s first two replacement procedures could not confirm whether or not patient presented with infection for surgery, since the surgeon has moved offices and discarded the patient's records. Additionally, the implanting physician did not have the resources to pull the patient's records from storage; and therefore, the office would not confirm if the patient had presented infection due to this surgery. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8483842
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dennis100
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« Reply #2936 on: May 18, 2019, 01:15:43 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2017
Event Type  Death   
Event Description
It was found during an obituary search that the patient had passed away. After follow up with the funeral home, it was stated that the cause of death was natural causes however the relation of the vns device was unknown. The funeral home also stated that the device was left implanted and buried with the patient. No additional relevant information has been received to date.
 
Event Description
It was reported by the physician that the cause of death for the patient was status (b)(6)likely provoked by an infection. This was stated not to be related to the vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6577847
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