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[Dispatch]

:D

Excellent points Birdbomb.

Gosh, I am sorry you can relate to the one specific patient.  That must have been awful for you!  So glad you waited to have the doc remove it.

B)

[dennis100]

Model Number 101
Event Date 10/09/2009
Event Type  Death   Patient Outcome  Death;  
Event Description  
It was reported that the pt died in 2009 at his group home. Per reporter, the pt was found by his attendant, nude in a dry bathtub, and was dry to the touch. Pt was transported to the hospital, but was pronounced dead. The death was not witnessed. Per the reporter, the pt's vns was turned off at the time of death. Follow-up with the medical examiner reveals that the cause of death is undetermined at this time. Based on the info received to date, the event has been determined to be a possible sudep by a manufacturer medical professional. The product was explanted from the pt and returned to manufacturer, but analysis is pending. A voluntary medwatch was submitted to fda regarding this event. Attempts to contact treating physician for further info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh...foi__id=1581925
 

[dennis100]

Model Number 103
Event Date 11/06/2009
Event Type  Injury   Patient Outcome  Other;  
Event Description  
It was reported that the recently implanted vns pt is experiencing syncope and pallor, which the mother believes to be a new seizure type. The mother reported to the nurse that two hours after an increase in the device's programmed settings, the pt became pale and absent. The mother explained that this has occurred the last two times the device settings have been increased. Review of the available in house programming history shows that the device settings have been increased incrementally about once a week. Device diagnostics have been regularly performed and the last available history reveals normal device function, which is from a f/u appointment in 2009. Good faith attempts to obtain add'l info have been made, but no add'l info has been received to date.
 
http://www.accessdata.fda.gov/scripts/cdrh...foi__id=1577946
 
 

[dennis100]

Model Number 103
Event Date 10/07/2009
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention  
Event Description  
Reporter indicated a vns pt was experiencing bradycardia, central apnea, and obtundation with vns stimulation. The vns is beneficial for the pt's seizure control, but the pt has a significant history of bradycardia with vns since 2001. The previous bradycardia event is reported via mdr #1644487-2006-00432. The apnea and obtundation, and continuing bradycardia, are noted since the pt was reimplanted with new vns products in 2009. If the vns is disabled for several hours, the pt has frequent, uncontrolled seizures. If the vns output current is reduced to 1. 0ma, the seizures increase. The pt has progressive bradycardia and obtundation, mostly responsive to arousal, within days to weeks after the vns output current is increased to 1. 25ma. The pt has central apnea, awake and asleep, when the vns duty cycle is increased. The apnea is intermittent and timed to periodicity of the stimulator. On the one occasion that a higher duty cycle was tried at 1. 0ma, the respiratory depression was progressive and lead to respiratory failure. The respiratory failure was treated in the intensive care unit at the hospital and managed by changing the vns settings. The pt is currently stable with infrequent partial seizures only as of two months later at his last clinic visit. The current vns settings are 1. 2ma/25 hz/250 pulsewidth/21 sec on/5 min off.
 
http://www.accessdata.fda.gov/scripts/cdrh...foi__id=1571192
 
 

[dennis100]

Event Date 05/01/2009
Event Type  Injury   Patient Outcome  Required Intervention; Other 
Event Description 
My daughter had her first vns implanted in 2004. She did not have success, had many traumas with her throat, and it ultimately caused paralysis to her vocal cord. We were advised by our doctors to get another - new and improved - vns since we are trying to avoid additional meds and surgery on this pt. When the surgeon opened the area to replace the old with the new, he discovered darkened tissue, corrosion, and a complete failure of the device. He said, he had never seen it in over 300 vns surgeries. Because of the extent of the problem, he had to replace more than the generator, and had to attempt removal of the wire that has long been encased in scar tissue. We were advised by cyberonics that they could fully investigate and contact the fda. After 7-months, cyberonics can only identify's dodge-ball hit 4 years ago as the cause of failure. The device has read "normal" during this entire time on every routine recheck. We would never have known of this failure if we didn't have a second surgery. Cyberonics' investigation states the cause is "blunt force trauma" 4 years ago. Indeed, being cautious parents, we did see her neurologist after that incident to ask if the ball could possibly have caused damage - the neurologist assured us, but performed the standard usual diagnostics and said the device was not damaged - again, 4 years ago. Cyberonics also advised today that her current neurologist - md - did not perform recommended "diagnostics" on her device while under his care - approx. 1 year, but only "interrogations" which would not reveal a "failure" status. Dr surely had no idea that was required or he would have done a diagnostic reading. We thought that he "interrogations" he was doing, were "diagnostic" evaluations. The question looms as to when the device failed, and how would we have known it was in this condition, buried under her skin, showing no signs of distress. Our earlier problem with her paralyzed vocal cord was also met with disinterest as we sought to discover that caused the permanent condition. We could only suspect the vns was ramped up too quickly to higher intensities. If that were true, they would simply have to re-examine their protocol, but they did no investigation into cause. We quietly went away without pressing for an answer. Now, another encounter with the cyberonics product is met with the same response. Why aren't they concerned that their device was indicating "normal" at every office visit? since it never controlled her seizures, there were zero signs it was in this state. Cyberonics advised that their last communication with fda was in august, and they reported "lead failure" as the cause. Now, we have a second vns in her chest - no seizure improvement; in fact, worsening, and we have no idea what went wrong or when. The surgery doctors also remain baffled. Is there any accountability in this investigation process? is it up to me to keep pressing for resolution, or does the fda hold them accountable for such serious incidents? vocal cord paralysis - and an electrical failure resulting in darkened tissue - three years later does not seem to warrant an unbiased investigation that goes beyond proving their own blamelessness. I asked them today for the fda report, hoping to glean something on why, when, or how the device failed. Cyberonics said, they would not provide that info. It feels we are left begging cyberonics for a responsible response to this incident. I have contacted them no less than 12 times in 7 months via phone calls and emails. Cyberonics "deal with us". It was never our intent to be their problem. Only to understand more fully the risks we are exposed to with their device, how we can protect our daughter from further harm, and assist them in identifying product concerns. Advised she would have to contact their legal dept. To provide fda info. Why is that? we are a modest family, and do not have access to a legal department. Do incidents such as this require a legal department to provide people who have trusted them with answers?.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1564881
 

[dennis100]

Model Number 103
Event Date 02/18/2010
Event Type  Death   Patient Outcome  Death; 
Event Description 
Reporter indicated that the pt had died. The cause of death was unk at the time of the report. The pt vns therapy device was removed by the medical examiner during the pt's autopsy, and returned to the mfr for analysis. The medical examiner stated that they wanted the results of the device analysis prior to finalizing the autopsy findings. The pt's vns device was received by the mfr for analysis, but analysis is not yet complete. As analysis is not complete, and the autopsy will not be finalized until the device analysis results are completed, the cause of death, and relationship of the death to vns therapy, is currently unk. Info was also received from the office of the pt's treating neurologist that the pt died in the hosp, but the reason the pt was in the hosp could not be given. The pt's device had only been programmed on for approx one week prior to the pt's death. The neurologist's office stated that the pt's death is not assumed to be related to vns therapy.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1644630

[dennis100]

Model Number 103
Event Type  Injury   Patient Outcome  Required Intervention; 
Event Description 
It was reported that a vns pt experienced an arrhythmia described as av block type ii as a side effect from vns therapy. Further information was received from the treating physician indicating the pt did not have any prior history of cardiac events and the av block occurred post operatively. Moreover, the physician indicated the arrhythmia did not correlate with the on time of the programmed device settings and did not occur while performing diagnostics. However, the av block occurred after a setting change as the output current was increased from 1 ma to 1. 5 ma. The treating physician believes vns exacerbated the av block and determined to be related to stimulation. At the moment, interventions taken were to program vns off and monitor the pt as the event recurred after vns was off. The treating physician would like to continue vns therapy while maintaining the pt under cardiac monitoring. Good faith attempts to obtain additional information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1641397
 

[dennis100]

Event Date 01/01/2004
Event Type  Injury   Patient Outcome  Required Intervention; 
Event Description 
It was reported that the pt experienced psychosis in 2004 which was believed to be directly related to stimulation. The physician indicated that the pt's seizures were well-controlled by vns, however, the pt had psychotic episodes involving the desire to kill his parents. The physician indicated that the device was programmed off and the psychosis subsided. At a later date, the physician wanted to program the pt's vns device back on, however, the mother was adamant that it not be turned on due to the harm the pt may try to cause her.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1667284

[dennis100]

Event Date 01/01/2003
Event Type  Injury   Patient Outcome  Life Threatening; 
Event Description 
It was reported in a scientific article that a pt experienced event of bradycardia along with vns stimulation. Ekg recording and monitoring of the pt showed that the heart rate was decreased and ranged from 10 to 20 beats per min. This decrease in heart rate correlated with the vns stimulation on time. The event took place at vns stimulation parameters ranging from 1. 75 to 2. 5 ma. No additional info was provided.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1643728

[dennis100]

Model Number 102
Event Date 03/13/2010
Event Type  Injury   Patient Outcome  Required Intervention; 
Event Description 
It was initially reported that a pt was having episodes of bradycardia with a heart rate in the 30s and was also experiencing a few episodes of asystole (each about 5 seconds in duration). The cardiologist thought it may possibly be related to the pt's vns device. A company rep went to the pt's next appt and was unable to interrogate the pt's device due to believed end of service. A battery life calculation was performed using the pt's programming history available in the in-house database (current from date of implant to (b) (6) 2009) and it was found that the device may be at end of service. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1658341
 

[Birdbomb]

Thank you for finding these, Dennis.  I especially liked this part...

It was reported in a scientific article

Ha-ha! Cyberonic$ won't be able to hide the flaws much longer.  It's going to be really interesting to see the REAL results of the case studies and long term results.  Dum-de- dum-dum!

<a href="http://www.youtube.com/watch?v=jHjFxJVeCQs" target="_blank">http://www.youtube.com/watch?v=jHjFxJVeCQs</a>

[dennis100]

Model Number 102
Event Date 03/01/2010
Event Type  Injury   Patient Outcome  Hospitalization;  
Event Description  
It was reported that the vns patient experienced a bradycardic episode after increasing output current from 1. 5 ma to 1. 75 ma. The patient's heart rate dropped from 86 beats/min to 63 beats/min. Patient's output current was reduced back to 1. 5 ma and this was the only intervention taken to preclude a serious injury. It is unknown if the patient had a medical history of bradycardia pre-vns. The neurologist does believe the event is related to vns. The event resolved after setting changes and did not reoccur. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1698091

[dennis100]

Event Date 04/02/2007
Event Type  Injury   Patient Outcome  Other;  
Event Description  
Initial reporter indicated that during a total system replacement for lead discontinuity, it was noted "the vagus nerve is quite damaged, probably due to the long and high stimulation parameters. Even with the possible unefficacy of the vagus nerve due to the degeneration, it was quite worthwhile doing the operation due to the pt situation". Programming was received and reviewed and the pt's programmed on time was greater than the pt's programmed off time. Reference mfr report number for lead malfunction: 1644487-2007-00252.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=841825
 
 
Report # 1644487-2007-00252
Event Date 04/02/2007
Event Type  Malfunction   Patient Outcome  Hospitalization;  
Event Description  
Reporter indicated that during replacement surgery for a generator at end of service, it was noticed "there was a lead break with the implanted lead". Reporter also indicated the pt had increased depressive symptoms with the generator being at end of service. At a later date the pt underwent an entire system replacement. Cyberonics is pending receipt of the explanted products for analysis.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950682
 

[dennis100]

Event Date 04/01/2005
Event Type  Death   Patient Outcome  Death;  
Manufacturer Narrative  
Approx 21 months prior to death, the pt experiened shortness of breath, constant chest pain, and palpitations following an increase in programmed parameters. The symptoms reportedly subsided when device parameters were reduced to pre-symptomatic levels. Reference medwatch report 1644487-2003-00482.    

Event Description  
Mfr periodically compares device-tracking info to the social security death index for the purpose of updating device-tracking data. During this process, mfr became aware of a pt death. Certifcate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died at his residence. Immediate cause of death is listed as sudden cardiopulmonary failure. Autopsy was not performed. Investigation to date has been unable to determine whether the reported event was related to the vns therapy system as the identity of the pt's last known treating physician is unk. There is no evidence that the vns therapy system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=678928
 
Report # 1644487-2003-00482
Event Date 07/12/2003
Event Type  Malfunction    
Event Description  
Reporter indicated that vns pt was experiencing an electric pulse at the generator site whenever the device is stimulating. It was reported that the sensation is in the chest area and felt like it was strong to "start their heart if they had a heart attack". Investigation to date has been unable to determine whether a device malfunction has occurred. No serious injury was reported in conjunction with the reported event. The pt temporarily stopped stimulation by taping the magnet over the device until this could be seen by their neurologist for device diagnostic testing.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477077