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Author Topic: Vocal Cord Paresis/Paralysis  (Read 263345 times)
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dennis100
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« Reply #780 on: September 07, 2018, 11:22:25 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/08/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was referred for battery replacement due to the battery being dead. During intubation during surgery the anesthesiologist noticed the left vocal cord was completely paralyzed. The patient will be referred to ent for evaluation. He decided to see what ent determines and decide whether to do a revision after that. Follow-up from the company representative further provided that there was weird scarring on the left vocal cord and the anesthesiologist had seen that the patient had a "collapsed left throat" clarified to mean vocal cord paralysis and that she had attributed it to the scarring. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7834842
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« Reply #781 on: September 07, 2018, 11:22:56 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2017
Event Type  Injury   
Event Description
Patient underwent generator and lead removal due to allergic reaction and extrusion. Patient also experienced vocal cord paralysis, which the surgeon suspects to be related to the allergic reaction. Patient's voice could be barely heard the day after he was implanted. Patient's voice has not improved much since then. The generator was removed because "it literally came out" of patient's chest. Per caregiver, patient has been a good healer in the past and has had multiple procedures without incident. The incision sites did not heal and there was oozing at the sites. The lead wire was sticking out of his chest as well and, so the lead was removed. Per surgeon, the vocal cord paralysis was noted prior to generator removal. The leads were not manipulated at that surgery and were left in the chest. The allergic reaction was present in both the chest and neck sites. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7824665
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dennis100
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« Reply #782 on: September 08, 2018, 01:02:22 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Following implant surgery, the patient was diagnosed with left vocal cord paralysis by an ent physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7795532
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dennis100
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« Reply #783 on: October 02, 2018, 12:43:54 AM »

Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead explant due to the high impedance. It was reported that a new vns system was not implanted at this time. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/16/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 02/18/2015. Note that the electrodes, plus one inner tube and quadfilar coil were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 314mm portion discoloration was observed on a portion of quadfilar coil 1 and the end appeared to be broken approximately 281mm from the end of the cut outer / inner silicone tubes. What appeared to be a greenish substance was observed inside inner silicone tubing 1 and quadfilar coil 1 appeared to be dissolved in this area. Scanning electron microscopy was performed on quadfilar coil 1 coil break found at 281mm and identified the area as being thin which prevented identification of the coil fracture type and evidence of electro-etching 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. The abraded opening and puncture marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, chlorine, zirconium, aluminum, sulphur and calcium. With the exception of the observed discontinuity 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 pins 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.
 
Event Description
Additional information was received on the patient's symptoms. The patient was experiencing dysphagia and hoarseness prior to being admitted to the hospital. The patient was then found to have left true vocal cord (tvc) paralysis. Due to a suspected abscess, the patient went into or for an incision and drainage procedure (found to be fluid collection not abscess). A lead fracture was then observed during the procedure with abraded insulation. The patient's neurosurgeon believes the lead fracture caused stimulation to surrounding neck tissue which led to necrosis and the fluid buildup. The neck fluid buildup is slowly resolving following vns removal. The patient is continuing to have hoarseness although dysphagia has improved. However, in his experience, the neurosurgeon believes tvc paralysis will likely be permanent due to nerve damage.
 
Event Description
It was reported that the patient was admitted to the hospital with a sore neck and vocal chord paralysis. Device diagnostics resulted in high impedance. The device was programmed off and the patient was referred for surgery for generator and lead replacement. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4453271
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dennis100
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« Reply #784 on: October 05, 2018, 12:53:49 PM »

Device Problems Fracture; High impedance
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had ongoing vocal cord paralysis (reported in mfg report #1644487-2018-01601) after the patient's leads were replaced due to an issue with the leads. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7876743
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dennis100
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« Reply #785 on: October 05, 2018, 12:54:42 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient had vocal cord paralysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7920130
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dennis100
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« Reply #786 on: October 06, 2018, 05:29:56 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/20/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that this patient has ongoing left vocal cord paralysis and is awaiting speech therapy after the patient's leads were replaced. Additional information was received from the neurologist stating that it was unclear if the vocal cord paralysis was due to vns stimulation, vns surgery or presence of the device, and root cause of the vocal cord paralysis is unclear. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7868185
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dennis100
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« Reply #787 on: October 06, 2018, 05:30:49 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/11/2017
Event Type  Injury   
Event Description
It was reported via social media comment by the patient that her left vocal cord was paralyzed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7847546

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dennis100
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« Reply #788 on: October 06, 2018, 05:31:36 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient had concerns with her voice alteration and feeling of something lodged in her throat. She had stated she had seen her surgeon who stated nothing was wrong but planned to follow up with the neurologist. Follow up with the physician's office noted that the patient had been seen since implant and the device had been turned on. The adverse events were also reported to his office and the patient was referred to the ent for evaluations because the events were not occurring with stimulation. Diagnostics were requested but not provided. Programming history data was reviewed and data observed was from the date of implant, showing no apparent device malfunctions. Further communication was received stated that the patient's vocal cords were "completely not working". No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7889639
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dennis100
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« Reply #789 on: October 06, 2018, 05:32:37 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a vns patient that she was experiencing voice alteration. The patient¿s physician called later and indicated the patient had been seen and that her left vocal cord was not moving correctly. He mentioned that system diagnostics were run and the impedance was fine. The device was programmed off. He stated that pt. Has been programmed to 2. 25 ma and rapid cycling for a while. The vocal cord paralysis was reported to have started in late june. He was concerned about delayed vocal cord paralysis. He also mentioned that the patient was examined by an ent who believes the event is related to vns. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7893985
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dennis100
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« Reply #790 on: October 07, 2018, 03:20:57 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/07/2016
Event Type  Injury   
Event Description
Information was received providing that the patient¿s most recent was complicated by left vocal cord paralysis, which is causing more hoarseness for the patient. No settings changes were made with the vns. The patient had previously stated she couldn't talk because of the vns. The patient¿s speech was slightly perseverative and slow but she did not have aphasia. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842046
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dennis100
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« Reply #791 on: October 25, 2018, 02:48:08 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients". Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25 ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the seventh of the eight vocal cord palsy events listed in the poster. The vocal cord palsy occurred post first insertion. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2810002
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dennis100
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« Reply #792 on: October 31, 2018, 01:59:56 AM »

Model Number 300-20
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was later reported on (b)(6) 2013 that the patient recently passed away due to cancer. The patient's obituary was found online and it stated that the date of death was (b)(6) 2013. It was reported that it was believed that the patient passed away from the thyroid cancer and that the death was not related to vns.
 
Event Description
Additional information was received on (b)(4) 2012 when it was reported that the vocal cord paralysis was first observed in early (b)(6) 2012; exact date not provided. The physician stated that the patient was seen by the radiology department and it was determined on (b)(6) 2012 that the patient has thyroid cancer. The patient is therefore being treated for thyroid cancer. The vocal cord paralysis was noted to be not related to vns stimulation. The patient was evaluated by an ent (ear, nose, and throat) physician and the outcome of the evaluation was that the patient has thyroid cancer. The physician does not think the thyroid cancer has anything to do with vns. No programming or medication changes preceded the onset of the vocal cord paralysis. The patient does not have a medical history of vocal cord paralysis prior to vns.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the vns patient was referred two weeks prior for an ear, nose, and throat evaluation as the patient was experiencing bilateral vocal cord paralysis and the neurologist it was possibly related to vns. No further information was provided at the time. It was previously reported that the vns patient was diagnosed by her ear, nose, and throat physician (ent) with vocal cord paralysis in (b)(6) 2010. The ent reported to the neurologist that the vocal cord paralysis was viral in nature and not related to vns. System diagnostics were performed on (b)(6) 2010, which showed the device to be functioning properly. The neurologist lowered the patient's frequency to see if that would affect the patient, but did leave her programmed on as he did not believe the paralysis was related to vns at that time. Attempts for additional information from the physician are underway but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852306
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dennis100
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« Reply #793 on: November 09, 2018, 02:46:34 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing difficulty breathing, wheezing, and throat tightness for which the vns was disabled. The patient was referred to an ent doctor, and it was determined that the patient was experiencing vocal cord paresis that occurred with vns stimulation. There was no reported medical intervention being taken for the events. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8021844
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dennis100
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« Reply #794 on: November 10, 2018, 04:11:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient went to the ent and was informed that she had vocal cord paralysis due to vns. The patient was unable to speak when the magnet was swiped on her device. It was stated this does not occur with normal and autostimulation and only occurs with magnet mode stimulation. The pulse width was lowered on all outputs. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7994895
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dennis100
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« Reply #795 on: November 12, 2018, 07:57:56 AM »

Model Number 304-20
Event Date 01/17/2013
Event Type  Injury   
Event Description
Additional information was received from the patient that she was diagnosed with left vocal cord paralysis by an ent. The patient reported that she is still having a hard time drinking liquids and regular foods. Clinic notes from the ent follow-up dated (b)(6) 2013 note that the patient experiences aspiration symptoms with think liquids and that she is on a thickened liquid diet. The notes also indicated that the patient is currently working with speech. Clinic notes dated (b)(6) 2013 indicated that the patient was improved since her last evaluation and that she was doing better with swallowing; however, that she was still on liquids. It was noted that her voice was stronger and that she would be sent for ent evaluation. Attempts for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated that she was admitted to the hospital the day after implant surgery for difficulty swallowing. The patient also reported that she was still having difficulty and was using liquid thickener to help. Further follow-up revealed that the patient was doing much better. Physician indicated that the patient has a "thick neck" and there was a lot of manipulation which caused swelling which caused the patient's swallowing issues. The physician indicated that the patient was doing much better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2962368
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« Reply #796 on: December 07, 2018, 10:35:52 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/24/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient was reported to have vocal cord paralysis following implant surgery. The device is currently not programmed on. No interventions are known to occurred or have been planned 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=8087005
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« Reply #797 on: December 07, 2018, 10:36:46 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during pre-op for an unrelated surgical procedure to remove the patient's thyroid that her ent physician diagnosed her with vocal cord paralysis. The patient reported that she had multiple surgeries on her neck to remove tumors. The vocal cord paralysis occurred in left vocal cord location, and the physician assessed that the cause of the vocal cord paralysis was the vns device surgery. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8061479
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« Reply #798 on: December 08, 2018, 02:35:33 AM »

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

Event Description
It was reported by a patient that he has had multiple vns surgeries and now has a paralyzed left vocal cord and trouble swallowing, which causes him to throw up medication at times. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8034856
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« Reply #799 on: December 10, 2018, 03:25:13 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had slight voice alteration with stimulation and that vocal cord paralysis was also observed during stimulation by the patient's physician. The vocal cord paralysis was occurring on the left side, and the vocal cord paralysis resolved when the stimulation was turned off. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8095884
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« Reply #800 on: December 15, 2018, 02:56:41 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 07/18/2013
Event Type  Malfunction   
Event Description
The physician indicated that the decreased motility of the vocal cord is probably related to vns therapy. The physician was unsure if the decreased motility of the vocal cord occurred with stimulation. The physician reported that the pneumonia has resolved and that the vocal cord paralysis is presumed to persist as her dysphonia has persisted.

Event Description
Clinic notes dated (b)(6) 2015 reported in the history of present illness that since the vns has been placed, the patient has developed some vocal cord problems and was seeing an ent. No vns programming changes were made.

Event Description
Additional information was received that the surgeon did a procedure to treat the vocal cord paralysis and not the patient is experiencing an increase in seizures. At this time the surgeon does not know the cause of the increase in seizures. No other information was provided.

Manufacturer Narrative

Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date.

Event Description
The patient was to follow-up with orl surgeon. Upon further follow-up with regards to the seizures, the physician did not think the seizures have increased. The patient¿s seizures are noted to be occasional.

Manufacturer Narrative
The supplemental report #3 inadvertently did not report this information from the physician.

Event Description
On (b)(6) 2013, it was reported that since the patient's vns revision surgery, the patient's voice has gone out. There were no further details on what this meant besides that the patient's voice got hoarse and the patient lost her voice temporarily. It was unknown whether this was with stimulation or not. The patient also had pneumonia after the surgery; however, the relationship to vns was unknown. Additional information was received that testing found the patient had some "sleepiness" of the left vocal cord. Per the physician, the pneumonia was likely related to the vocal cord not working as it probably allowed the patient to aspirate, causing the pneumonia. On the one month post-op visit, the physician noted that the wounds had healed nicely at that time. The patient was quite hoarse after surgery. Examination of the vocal cords indicated decreased mobility of the left vocal cord. It was noted that the vocal cord was not paralyzed, but had decreased mobility. The patient was experiencing mild aspiration. The physician gave the patient swallowing tips and recommended potential further action if the event did not improve; however, he was hopeful for resolution as there was some mobility. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322853
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« Reply #801 on: December 17, 2018, 04:27:04 AM »

Model Number 103
Event Date 08/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.

Manufacturer Narrative

Event Description
It was reported that the patient caused an infection both in the left chest and left neck. The removal of the device and lead was performed on (b)(6) 2013. The event started in (b)(6) 2013. The physician believes the event is related to vns surgery. Follow up with the site found that according to the physician's assessment, there are three possibilities of the relationship of the infection to vns: 1. Bacteremia caused by her urologic disease. 2. The physical friction when parents carried the patient. 3. Rejection for the alien substance. In particular, the infection was located in the left chest at the generator and in the left neck by the lead. Cultures were taken, but the results were not confirmed yet.

Event Description
A research article comprised of data from a hospital's study of efficacy for pediatric vns patients implanted between (b)(6) 2010 and (b)(6) 2015 was received. Within the article, it was reported that two patients; data was excluded from the study due to one patient death during the monitoring period and one patient infection preventing the patient from continuing with vns. Clarification received from the physician indicated that the death and infection had previously been reported to the manufacturer, and the provided patient identifiers aligned with the report of patient infection captured in this report. The reported patient death is discussed in mfr. Report # 1644487-2014-00651. In addition to a suspicion that the infection occurred as a foreign body response, the physician also reported that the patient caused the infection in the left chest and neck. No additional relevant information has been received to date.

Event Description
An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between (b)(6) 2010 and (b)(6) 2016 was also received. The abstract indicated that four patients experienced recurrent vocal cord paralysis. The abstract also indicated that one patient experienced subsequent aspiration pneumonia. Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture. The recurrent vocal cord paralysis is reported within mfr. Report # 1644487-2018-00123. A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368, the second of which corresponds to the events captured within this report. The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr. Report # 1644487-2018-00289. No additional relevant information has been received to date.

Manufacturer Narrative
Okanishi t, & fujimoto a. (2017). Insufficient efficacy of vagus nerve stimulation for epileptic spasms and tonic spasms in children with refractory epilepsy. Epilepsy research 140 (2018) 66-71. Doi: 10. 1016/j. Eplepsyres. 2017. 12. 010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3413364
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