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Author Topic: Misc. Reports  (Read 408297 times)
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dennis100
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« Reply #1050 on: October 06, 2018, 04:03:33 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/09/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to the vns causing issues with his nervous system. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7849291
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dennis100
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« Reply #1051 on: October 07, 2018, 02:18:46 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 08/29/2018
Event Type  Malfunction   
Event Description
It was reported by an mri technician that a vns patient had stated their device had ¿malfunctioned¿. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7896780
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dennis100
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« Reply #1052 on: October 22, 2018, 01:43:36 PM »

Event Type  Malfunction   
Manufacturer Narrative
Citation: vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center. By gilad horowitz, moran amit, itzhak fried, miri y. Neufeld, liad sharf, uri kramer, and dan m. Fliss. Eur arch otorhinolaryngol springer- verlag 2012.
 
Event Description
The following article was received for review. Vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center" by gilad horowitz, moran amit, itzhak fried, miri y. Neufeld, liad sharf, uri kramer, and dan m. Fliss. The article discusses the implantation and outcomes of 100 vns patients. Information reports that a vns patient had a general performance issue, reported as a failure with the device. No specifics provided. Attempts for further information have been made and no further information attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2727639
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dennis100
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« Reply #1053 on: November 01, 2018, 02:30:02 AM »

Model Number 103
Event Date 10/18/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported during a (b)(4) that a canine participant's generator settings spontaneously change. This generator model is the same model generator that is currently approved for commercial distribution. It was reported that on two occasions, the canine participant's pulse width value spontaneously changed when the output current value was intentionally programmed. On one occasion the pulse width reportedly changed from 250 usec to 500 usec and on the other occasion the pulse width reportedly changed from 250 usec to 750 usec. Further follow up reported that there were no programming handheld response issues. Additionally, the new pulse width values reportedly did not appear altered on the programming handheld software screen prior to reprogramming with the new output current. There were no reported adverse events related to the change in settings. Good faith attempts for additional information including programming history from the clinical study site are currently underway.
 
Event Description
Additional information was received that the serial number was previous provided was incorrect. Review of programming history from the study site's handheld showed that the patient was programming to those settings and they did not spontaneously change as initially reported.
 
Manufacturer Narrative
The initial report reported the serial number for the generator which was provided by the site but later it was learned the serial number was incorrect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2840042
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dennis100
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« Reply #1054 on: November 07, 2018, 01:29:05 AM »

Event Date 09/09/2011
Event Type  Injury   
Event Description
The pt's husband reported that he wanted the device removed. Per the reporter, the pt had "nothing but problems and they had to have it shut off and now they have to have it removed". Specifics were requested, but the report only stated the pt "drooled a lot and had difficulties". Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276546
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dennis100
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« Reply #1055 on: November 08, 2018, 01:04:36 AM »

Model Number 102
Event Date 07/31/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the treating neurologist that the patient had visited the physician and the parents complained that the vns 'never worked right',but he refered all questions to another physician. When the other physician's office was contacted by the manufacturer, the office did not know what the vns was or what the family meant by 'never worked right. ' when the physician who originally sees the patient was contacted again, he did not have any information either. The patient is being referred for vns generator replacement surgery due to end of service, but surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901850
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dennis100
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« Reply #1056 on: November 09, 2018, 01:23:04 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
It was reported that during a visit to a developmental home, the company representative was approached by a woman who informed him that the vns had "fried her niece's heart and killed her. " the woman walked away immediately and no further information was provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7958253
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dennis100
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« Reply #1057 on: December 07, 2018, 08:10:51 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/02/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
A potential patient reported their aunt had the vns device and ended up in a vegetative state. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8095902
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dennis100
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« Reply #1058 on: December 22, 2018, 08:25:57 AM »

Type of Device:      vagus nerve stimulator
Device Brand         VNS Therapy Aspire HC
Name:
Device                  Cyberonics, Inc.
Manufacturer's
Name:
Date of this           09/05/2014
Report:
(mm/dd/yyyy)
Describe the          Patient was taken to the operating room (OR) to have a battery change in the patient's
Event                    Vagus Nerve Stimulator. Post-surgically there was concern that the device was not
or Problem:           functioning correctly even though it had been previously checked in the OR.
                            Indication is that the manufacturer has made changes to the device impedance
                            thresholds that the surgical staff were not aware of. The Neurosurgeon is
                            currently working with the manufacturer to identify a solution and will follow up 
                            with this particular patient's family (patient is a pediatric). There was concern
                            post-operatively that the patient may need to return to the OR for an additional
                            procedure. Manufacturer response: The Neurosurgeon contacted the Cyberonics
                            representative directly and continued communicating with the company
                            representative. The OR staff shared concern that they did not receive any prior
                            communications regarding either software or hardware changes from the
                            manufacturer. They say that the thresholds for impedance were changed by the
                            manufacturer.
the device(s)
may have              Potential for patient harm
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=41379



« Last Edit: December 22, 2018, 08:52:21 AM by dennis100 » Logged
dennis100
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« Reply #1059 on: January 02, 2019, 01:12:05 AM »

Model Number 102
Event Type  Injury   
Event Description
The abstract of the article ¿vagus nerve stimulation therapy in epilepsy patients. Long-term outcome and adverse effects: a retrospective analysis¿ was received and reviewed by the manufacturer. Please see abstract below: ¿background: vagus nerve stimulation (vns) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects. Topics: decision-making process on vns therapy as well as long-term outcome and adverse effects. Method: retrospective analysis of all 62 patients treated over a long period by vns in the epilepsy center of the university hospital of freiburg (germany) from 1 august 2002 through 4 january 2011. Results: outcome: the results show that 2 out of 62 patients became seizure-free under vns therapy while maintaining the already existing anti-ictal medication and 4 more patients under vns plus dosage increase of the already existing medication and/or new medication. However, in 34 out of 62 patients vns therapy did not improve the seizure situation. Adverse effects: vns is not as low in adverse effects as is generally considered. Only 9 out of 62 patients did not show any adverse effects and on the other hand severe, even life-threatening adverse effects also occurred. Conclusion: patients undergoing vns therapy have to be carefully checked for possible adverse effects, not only at the beginning of vns therapy but also in the long-term course. These results have to be considered in the cost-benefit analysis of this treatment. ¿ the article, written in (b)(6), was later received by the manufacturer. Per the article, thirteen patients experienced adverse events related to the vns surgery or vns. A translation of the chart with patient information and outcomes revealed the following adverse events were observed: necrosis, increase in seizures (that were possibly psychogenic), wound infections, secondary rupture of sutures, recurrent laryngeal nerve paresis, horner¿s syndrome, wound dehiscence, lead break, and asystole. The following manufacturer report numbers are associated with each patient and their respective events: mfr #: 1644487-2014-00031 -- asystole, associated with vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 -- lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00040 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Event Description
Follow up with the physician was performed. The physician stated that he had reported these events to the manufacturer in time and he was not willing to support any further dialog regarding these issues. The physician confirmed that there were no critical situations around the vns and that in cases where vns was critical, the device had been disabled and/or explanted. No additional information was provided.
 
Manufacturer Narrative
Date of birth, corrected data: initial mdr inadvertently provided the incorrect information. Sex, corrected data: initial mdr inadvertently stated this information was unknown; however, the information was known at the time. Brand name, corrected data: initial mdr reported that this information was unknown; however, the information was found in the manufacturer's database. Model 3, serial #, corrected data: initial mdr reported that this information was unknown; however, the information was found in the manufacturer's database. If implanted, corrected data: initial mdr inadvertently provided the incorrect information. Attachments, corrected data: the article was inadvertently not attached to the report. Describe event or problem, corrected data: the initial mdr inadvertently referenced the related mfr numbers incorrectly. The following manufacturer report numbers are associated with each patient's respective events reported in the article: mfr #: 1644487-2014-00031 -- asystole related to vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery and psychotic episodes associated with vns. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 - lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00040 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3550166
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dennis100
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« Reply #1060 on: January 04, 2019, 08:08:57 AM »

Model Number 302-20
Event Date 12/12/2018
Event Type  Malfunction

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8207017
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dennis100
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« Reply #1061 on: January 05, 2019, 01:02:45 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/02/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
While following up on a report of high impedance captured in mfr #1644487-2018-02133, it was reported by the patient's surgeon that the patient could not tolerate even low settings of the generator, so the patient's vns may be explanted, rather than replaced. It is unclear whether the tolerability issues are related to the high impedance. No 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=8136241
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« Reply #1062 on: January 05, 2019, 01:03:21 AM »

Event Date 01/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the vns side effects can be extreme. The reporter suggested that vns should only be tried in the worst cases and ¿seizures are better than death. ¿ the reporter expressed concern about the vns materials used.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4624809
« Last Edit: February 15, 2019, 01:45:23 AM by dennis100 » Logged
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« Reply #1063 on: February 14, 2019, 01:04:53 AM »

Model Number 103
Event Date 01/07/2015
Event Type  Death   
Event Description
It was reported that the patient was seen by the physician on (b)(6) 2015. The vns was working fine and the physician decreased the off time from 1. 8 min to 1. 1 min and no other settings were changed. The patient stayed with a family member in the waiting room for an hour and tolerated the changed to the settings well. The patient went home and a few hours later, family member stated that they found him in the bathroom unresponsive. Exact cause of death is unknown; however, the physician stated she did not feel that the cause of death was due to vns. The patient underwent an autopsy but there is no ruling yet on the cause of death. It was noted that the vns device was explanted but the medical examiner¿s office keeps the device for two years. The physician later reported that the patient had concurrent illnesses of cognitive delay and psychosis. She stated it was unknown what the cause of death was and the relationship of the patient¿s death to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4486693
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