Pages: [1] 2 3 ... 10
 1 
 on: Today at 02:42:05 AM 
Started by dennis100 - Last post by dennis100
Model Number 101
Event Date 03/03/2008
Event Type Injury
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608

 2 
 on: Today at 02:41:10 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 10/18/2011
Event Type Injury
Manufacturer Narrative

Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562

 3 
 on: Today at 02:40:15 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 03/11/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear. Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear. Her generator site was hurting and her brain was foggy. The patient then visited the nurse practitioner on (b)(6) 2016. During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before. Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation. The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation. So the magnet pulse width was decreased down to be the same as normal stimulation. Diagnostics were performed and were within normal limits. X-rays were taken afterwards and no issues were observed. Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016). Since the shock with the magnet, patient felt that her heart would beat really fast. This happens about once a day at different times of the day and can last 10-30 min. This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse. She never had this happen before and there are no triggers that patient could find. Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.

Event Description
Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation. No known causes or contributory factors were present. Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation. The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation. Per the medical profession, there was no device migration as she could not perceive any movement of the generator. The pain in the chest was not due to presence of device or migration. Patient has had her generator replaced since then on (b)(6) 2016 and is doing well. The explanted device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549412

 4 
 on: Today at 02:38:43 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 10/18/2011
Event Type Injury
Manufacturer Narrative

Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562

 5 
 on: Today at 02:37:03 AM 
Started by dennis100 - Last post by dennis100
Model Number 101
Event Date 03/03/2008
Event Type Injury
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608

 6 
 on: Today at 02:35:57 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Event Date 05/02/2016
Event Type Injury
Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.

Manufacturer Narrative
(b)(4).

Event Description
An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685905

 7 
 on: Today at 02:35:29 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Event Date 06/01/2011
Event Type Injury
Event Description
It was reported by a physician's office that the pt was complaining of chest pain, coughing, and pain in her right arm that started approx two weeks prior. The pt had been to the er and the physicians ruled out "other issues" and told the pt that the symptoms "must be the vns. " the pt was at very low settings and could not tolerate any higher programming. The pt swiped her magnet and had significant cough and tightening of her chest. Also, the pt was unable to tolerate the system diagnostic testing parameters to test device function. The device was disabled to see if the issue resolved. Also, the pt is not currently taking any different medications than in the past. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2201826

 8 
 on: Today at 02:35:03 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 08/01/2010
Event Type Injury
Event Description
It was reported that the vns patient experienced a sudden onset of painful stimulation in the neck with magnet mode stimulation. Follow up with the treating physician revealed that there were no causal or contributory programming changes or trauma that preceded the onset of the event. Recent diagnostic testing done on the device has revealed normal device function. X-rays were taken and sent to manufacturer for review. Review of x-rays revealed no anomalies that could be contributing to the reported event. The physician opted to decrease the device settings when the event initially began, which did appear to provide some relief initially. However, the patient had contacted the physician's office several days later, experiencing severe dysphagia, and the physician programmed the normal mode output current off at that time. The patient requested that the magnet mode stimulation remain programmed on, as she uses the stimulation for anxiety. Good faith attempts to obtain additional information are currently underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851127

 9 
 on: Today at 02:34:37 AM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Device operates differently than expected
Event Date 11/12/2015
Event Type Injury
Event Description
It was reported that the patient swiped her magnet and the stimulation was so strong it made her cry. Subsequent device stimulation (normal mode and magnet mode) was painful. The magnet was used to disable the device and the patient was seen by the physician. Device diagnostics were within normal limits and the device was not at end of service. The patient was sent for x-rays. The patient underwent generator and lead replacement due to the painful and shocking stimulation. The explanted devices have not been received for analysis to date.

Event Description
The generator and lead were received for analysis. Analysis of the generator was completed on 01/04/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Event Description
Analysis of the lead was completed on 01/11/2016. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5272254

 10 
 on: Today at 02:33:33 AM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Event Date 03/01/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Patient had surgery on (b)(6) 2016. The lead had a complete break with multiple knots, indicative that the patient twisted the device. The patient also must have twisted the generator as it was no longer anchored to the fascia. It is believed that the patient's fall as well as manipulation contributed to the break. The lead was received for analysis on 04/21/2016. Product analysis is underway but has not been completed to date.

Event Description
It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.

Event Description
Product analysis for the lead was completed and approved on 05/18/2016. A break was identified in both positive and negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Scanning electron microscopy images of both positive and the negative coils suggest a stress¿induced fractured (due to rotational forces) occurred. Scanning electron microscopy images of the negative coil at the break located past the anchor tether show that a stress-induced fracture (due to rotational forces) occurred on the coil. The overall appearance of the lead coils past the electrode bifurcation is consistent with patient manipulation of the implanted device, a ¿twiddler. ¿ the inner silicone tubing of the negative coil has dried remnants of what appear to have once been body fluids inside the inner silicone tubing at the break location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551724

Pages: [1] 2 3 ... 10