Pages: 1 ... 133 134 [135]   Go Down
Print
Author Topic: Increase/Worsening of Seizures  (Read 661497 times)
0 Members and 6 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4020 on: October 10, 2018, 03:29:44 AM »

Model Number 302-20
Event Date 08/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated that the events began on (b)(6) 2012. Additional information was received that the problems have been occurring for almost a year. This report is being submitted to correct this information.

Event Description
On (b)(6) 2012, a fax was received from the physician's office. The fax indicated that the painful stimulation at the generator site and the partial paralysis were related to vns. The patient's device was disabled as an intervention, and explant is planned. The patient denied any trauma. No programming history was available as the patient was implanted at another site. The patient did not have a medical history of paralysis; however, it was noted that the patient had a cva prior to vns. The patient had not been evaluated by an ent. The patient wished for the device to be explanted due to pain and paralysis. The device was reportedly not working due to the patient experiencing pain. The patient's mother reported that device was inconsistently on and off. Surgery is still likely, but has not taken place.

Manufacturer Narrative
Review of additional programming history.

Event Description
On (b)(6) 2012, this vns patient reported increased seizures, generator migration, partial paralysis, shocking generator, and jumping in the neck. The patient's physician believed that the temporary paralysis was due to the consecutive seizures, not vns. On (b)(6) 2012, the patient's family member reported that the patient was last seen by her physician three weeks prior to (b)(6) 2012. The family member stated that the patient needed the device disabled due to migration and pain and requested assistance finding a closer physician. On (b)(6) 2012, it was reported that the patient had a mini-stroke and needed an mri. Attempts for additional information are underway.

Event Description
On (b)(6) 2013, the patient was seen for consult for surgical removal of the device. The patient apparently some issues regarding pain and migration of the generator around the left breast area. The wound appears to be well healed in the cervical and pectoral area, and no infection appears to be present. Nonetheless, the implant is not helping her. The device was currently disabled. Surgery is likely but has not taken place. Review of additional programming history showed that the pt's's device was disabled on (b)(6) 2012. A system diagnostic from (b)(6) 2012 indicated normal results.

Event Description
On (b)(6) 2012, the physician's office reported that the patient wanted her vns explanted. On (b)(6) 2012, follow up with the physician's office revealed that the patient wanted the device explanted because she was being evaluated for a stroke, and the device was not working properly. The office could not clarify what was meant by "the device was not working properly. " the patient just wanted the device out, and the physician was agreeable to that. The patient was first evaluated in the office on (b)(6) 2012. The paralysis was on the left side of the patient's body. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Event Description
On (b)(6) 2012, this vns patient reported that her physician stated that something was wrong with the wiring at the patient's (b)(6) 2012 appointment. The patient did not have specifics about the issue with the wiring but reports that the physician did run tests on the device. The tests and results are unknown. The patient reported that she was experiencing generator protrusion, generator migration, lead body protrusion, numbness on the left side of her body, pain at the chest/generator site, and painful stimulation. The patient said she never had any issues prior to this. The patient also reported that she does sometimes fall but cannot associate any specific incident prior to the start of the adverse events. It was reported that an order had been sent in for x-rays; however, attempts for any additional information have been unsuccessful to date.

Manufacturer Narrative
Adverse event or product problem, outcomes: corrected data: previously submitted mdr stated that the reported event was a malfunction. Additional information was received indicating that a serious injury requiring intervention occurred. This report is being submitted to correct this information.

Manufacturer Narrative

Event Description
On (b)(6) 2012, this vns patient called complaining of a shocking sensation and generator movement. Attempts for additional information have been unsuccessful to date.

Event Description
On (b)(6) 2012, this vns patient reported that she wanted her generator explanted. She stated that the device had been causing her problems for almost a year. She stated that it is not sitting in the pocket like it should be, and when she lies down, it "floats up" causing discomfort. She stated that she had a mini stroke a few months ago and around the same time, her device was turned off because it was shocking her. She stated that about 4-5 months ago, she was to have her explant scheduled, but it just had not happened. She had spoken with the surgeon in regards to her discomfort and was told that she doesn't have enough tissue in the area where she is implanted which may be the cause for the discomfort. She stated she had not experienced any manipulation or trauma that may have caused either the migration or the shocking sensation. Surgery is still likely, but has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2554727
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4021 on: October 10, 2018, 03:30:41 AM »

Model Number 104
Event Date 04/18/2014
Event Type  Malfunction   
Manufacturer Narrative
Event Description
It was reported that the vns patient was experiencing an increase in seizures. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808553
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4022 on: October 16, 2018, 03:19:41 PM »

Model Number 102
Event Date 10/10/2011
Event Type  Malfunction   
Event Description
It was reported that a pt was experiencing an increase in seizure frequency. The pt's neurologist relocated, and the pt was in need of physician f/u. No further info was provided in regards to this event. Good faith attempts to obtain add'l info have been unsuccessful to date. Any add'l info will be reported if received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340750
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4023 on: October 19, 2018, 11:57:16 AM »

Model Number 102R
Event Date 08/16/2012
Event Type  Malfunction   
Manufacturer Narrative
Event Description
It was reported that the physician was unable to interrogate the patient at a follow up visit on (b)(6) 2012. The physician confirmed that the handheld was not plugged in at the time. It was indicated that the physician was unsure if the patient's generator was depleted; however, the patient had also reported experiencing an increase in seizures. The patient was scheduled to follow up with the physician and a manufacturer's representative so that additional troubleshooting can be performed. This has not occurred to date. A battery life estimation was calculated which revealed that the generator may be at or nearing end of service. However, this has not yet been confirmed.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the patient was able to be interrogated during a clinical visit that day. The patient's settings were output=2. 5ma/frequency=30hz/pulse width=130usec/on time=7sec/off time=0. 3min/magnet output=2. 25ma/magnet pulse width=130usec/magnet on time=60sec/neos=no. A normal mode diagnostics test was performed that day which showed output=ok/lead impedance=ok/dcdc=5/eri=no. The physician attributes the seizures to kidney stones, not vns. Troubleshooting was performed on the programming system and it was discovered that the wand battery needed to be replaced; there were no issues with the handheld and wand.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744212
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4024 on: October 25, 2018, 03:28:49 AM »

Model Number 102
Event Date 10/03/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Follow up with the physician found that he was unable to answer any questions regarding the bradycardia. The physician did not fill out the arrhythmia questionnaire as it was stated that no arrhythmia was observed by the office. It was unknown if the patient had a medical history of bradycardia; however, it was stated that the ekgs was consistent with sinus bradycardia. No additional information was provided.

Event Description
On (b)(6) 2012, a pediatrician called to report that their patient was experiencing an increase in seizures, muscle spasms, and had a clicking noise emanating from his neck. These events are addressed in (mfr # 1644487-2012-02809). During this call it was mentioned that the patient had mild bradycardia. It is unknown at this time if the bradycardia is related to their vns therapy or not, as all attempts have been made to get additional information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2810292
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4025 on: October 26, 2018, 01:56:42 AM »

Model Number 103
Event Date 02/03/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A fax was returned from the patient's physician on (b)(6) 2012, indicating that the event was not related to vns.
 
Event Description
Clinic notes dated (b)(6) 2012 indicated that this vns patient was hospitalized the previous week for extreme lethargy seconds to benzodiazepine used for exacerbation in seizure activity. The patient had returned to baseline seizure activity with the exception of the previous day when she experienced four generalized tonic-clonic events. No drop seizures were noted. The patient's average of generalized tonic-clonic events was once per week. The patient experienced daily staring spells. The patient was healthy in general with no new problems elicited. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2805215
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4026 on: October 27, 2018, 01:23:44 AM »

Model Number 100
Event Date 06/16/2003
Event Type  Injury   
Event Description
On (b)(6) 2012, it was noted that this vns patient underwent complete revision on (b)(6) 2004 for an unknown reason. Information was also received that this vns patient's seizure activity had increased on (b)(6) 2003. Attempts for additional information will be made.

Event Description
Additional information was received on (b)(6) 2012, that the device was likely discarded as it could not be located. The patient's physician at the time of the event is not available for follow-up. Programming history shows that the patient's device was last interrogated with a battery status no on (b)(6) 2004.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2785806
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4027 on: October 27, 2018, 01:24:28 AM »

Model Number 105
Event Date 03/29/2013
Event Type  Injury   
Event Description
Upon investigation for the patient's increased seizures prior to generator replacement on (b)(6) 2013 as captured in mfg report number: 1644487-2013-00214, it was reported by the neurologist that the patient experienced an increased seizure frequency and more violent seizures since generator replacement. The increased seizure frequency was above pre-vns seizure frequency level reportedly. Following generator replacement, the patient was programmed to the same settings as prior to generator replacement and there were no medication changes at that time. Settings were temporarily decreased then returned to prior setting levels. No other interventions were taken. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3185419
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4028 on: October 29, 2018, 11:23:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that the patient was experiencing an increase in seizures. The patient's mother felt that the vns was no longer working because the patient no longer coughed with magnet activation. No interventions are known to have been planned or taken to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7541841
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4029 on: November 03, 2018, 12:49:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/21/2018
Event Type  Injury   
Event Description
It was reported that the patient's seizures had increased in duration. The patient's neurologist doubted the vns to be causative as the device's settings are still being increased to therapeutic levels. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7346089
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4030 on: November 03, 2018, 12:50:09 AM »

Model Number 102R
Event Date 02/20/2012
Event Type  Injury   
Event Description
Clinic notes were received for review. A vns patient has been referred for a prophylactic battery replacement. Clinic notes dated (b)(6) 2012 state that the patient's seizures are as frequent but more prolonged and that the magnet was not effective for rescue. On (b)(6) 2012: office visit reported. The seizures are as frequent but more prolonged. Status post vns implantation. Significant improvement was noted. Titration in progress. Vns was interrogated and titrated. He had still 2-4 reported seizures per month. There was no specific timing or identified trigger. He described typically brief seizures with right sided clonic activity. More prolonged convulsion were reported with loss of consciousness, screaming and postictal amnesia vns was interrogated and titrated: 2 ma -- 62; 2. 25ma. 20 hz. 250 micros. 21 seconds on -- 62; 21 sec. 3 minutes off -- 62; 3 min. 2. 25mamp. No malfunction was identified. The magnet was not effective for rescue. The stimulation was well tolerated. Good faith attempts are underway for further details about the reported event of prolonged seizures. Thus far no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887041
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4031 on: November 04, 2018, 01:58:48 AM »

Model Number 103
Event Date 10/26/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing an increase in seizures. The nurse thinks the pt may be a non-responder to vns, though this has not been confirmed. The nurse tried adjusting the settings to see if it helps the seizures. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910103
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4032 on: November 07, 2018, 02:18:28 AM »

Model Number 103
Event Date 01/07/2011
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt had an increase in seizures above pre-vns baseline. The treating nurse believes that the increase in seizures is due to loss of therapy. There has been many medication and programming changes for pt's seizure control. Additionally, pt complained about painful stimulation which did not resolve with settings adjustment. Placing a magnet over the generator to disable the device; however, alleviated the pain in neck. There has been no trauma or manipulation to the vns generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993856
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4033 on: November 08, 2018, 02:14:20 AM »

Model Number ASKU
Event Date 12/04/2012
Event Type  Injury   
Event Description
A manuscript titled "efficacy of vagus nerve stimulation in intractable epilepsy patients in cyprus" was received by the manufacturer for review. The article discusses efficacy of vns over time, which was analyzed in 27 patients. Within the section titled "surgical results, complications, and device removals," it was reported that one patient had vns removed due to occasional neck pain related to duty cycle. It was found among the patients that exhibited this symptom that upon alteration of the vns parameters the pain symptoms would usually subside. It is unclear from the manuscript if the explant was taken for patient comfort or to preclude a serious injury. Attempts for additional information have been unsuccessful to date. The report of one patient who developed an infection is captured in mfg report number: 1644487-2013-00102. The report of one patient who had vns explanted due to dysphagia associated with vns stimulation is captured in mfg report number: 1644487-2013-00103. The reports of two patients who died of sudden unexpected death in epilepsy (sudep) are captured in mfg report numbers: 1644487-2013-00104 and 1644487-2013-00105. The report of one focal patient who had 0% change in the seizure frequency or worsening of seizures is reported in mfg report number: 1644487-2013-00101.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2903526
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4034 on: November 08, 2018, 02:15:01 AM »

Model Number 103
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 11/30/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was indicated that the patient's device was explanted and that the surgeon did not know the exact reason for explant, but stated it was due to a device malfunction. No pre-operative diagnostics were performed at the surgery, and the surgical team did not know the reason for explant. No explanted device has been received to date. No additional relevant information has been received to date.
 
Event Description
It was reported by a patient that with vns, her seizures have changed and increased. The patient also states that when her heart rate rises, she has increased seizures and states that the device works up her heart rate. No surgical intervention has taken place to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140631
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4035 on: November 09, 2018, 03:08:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2018
Event Type  Malfunction   
Event Description
The patient called and reported that since having vns implanted he has had an increase in seizures despite no change in medications. Attempts were made to the physician for further information and clinic notes were received. Per the notes, the patient recently stopped taking lamictal, which was acting as a mood stabilizer and that vns settings were increased at the visit, which the patient tolerated well. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8009825
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4036 on: November 09, 2018, 03:09:04 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
It was reported by the patient that he had 110 seizures so far this year with the record from last year being 115. The patient felt that he would exceed the previous year's seizure count, indicating an increase in seizures. The patient saw a new physician, who made some changes to the vns settings. Follow up with the patient's new physician's office revealed that they were unable to provide a comparison on the increase in seizures and the pre-vns baseline as the patient had only been seen once in clinic. The physician's assessment on the increase in seizures was that it was due to low tolerability and side effects from high vns output currents as well as significant tissue damage. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8010226
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4037 on: November 09, 2018, 03:09:46 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient's primary care physician that the patient was being treated for intractable hiccups that began post implant of vns. Vns was stated as a possible cause of the hiccups. Upon further investigation it was found that the patient began experiencing hiccups about 6 months ago and also started experiencing an increase in seizures around the same time that are more intense and last longer. The patient is reported to have fallen and hit his head several times. Multiple attempts for relevant information were made, but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7995308
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4038 on: November 09, 2018, 03:10:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that a patient's seizures have been bad and that her magnet has not been helping. It was stated that her seizure convulsions were longer and stronger, and it takes her longer to fully come out of a seizure. The patient had a car accident and was not sure if the accident had affected her device. The patient further reported an increase in seizures. Programming history was reviewed, and the last settings provided to the manufacturer's was from (b)(6) 2018. The last diagnostics performed were from the date of implant where the device was shown to be functioning as intended. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8020796
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4039 on: November 09, 2018, 03:11:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2018
Event Type  Injury   
Event Description
It was reported through clinic notes that the patient experienced an increase in seizures after their autostimulation output current was increased. As a result, the patient's autostimulation was reduced to the previous level. The patient's diagnostics were ok. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8025956
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4040 on: November 10, 2018, 04:27:23 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/03/2018
Event Type  Injury   
Event Description
It was reported that a vns device was replaced due to battery depletion and was received by the manufacturer. Analysis was completed for the returned generator. The end-of-service condition was not confirmed. There was no indication from the device that an end of service condition existed. The device performed as expected according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found. Follow-up from the provider verified that the replacement was prophylactic, and the device was not at end-of-service. The patient was reported to have had an increase in seizures. It was unknown if the increase in seizures was due to vns therapy. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7930800
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4041 on: November 10, 2018, 04:27:52 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was in the hospital for increased seizures and might get a battery replacement while in the hospital. Clinic notes from the patient's most recent office visit noted that the patient's device was checked and was working fine. Battery life was at "one quarter", so the physician referred the patient for prophylactic battery replacement as settings are high and "maxed out". The replacement took place and the implant card indicated that the replacement was prophylactic. It was noted that the hospital is a no return site as they discard. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939235
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4042 on: November 10, 2018, 04:28:28 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/09/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The mother reported that prior to the patient's previous replacement, once the battery depleted, the patient had an increase in seizures which required hospitalization. Per analysis of the explanted generator, it was at near-end-of-service condition and therefore was still supplying intended therapy upon explant. Analysis concluded that no anomalies existed with the generator and the near-end-of-service (neos) condition is an expected event. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7951674
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4043 on: November 10, 2018, 04:29:10 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to issues including dysphagia, ataxia, weight loss of 10 pounds since (b)(6) 2018 (implant month of current vns generator), an increase in general tonic-clonic seizures and changes in neurological status: lethargy and muscle weakness. The patient's device was turned off to see if symptoms improved. The doctor believed that the patient may have an allergy to titanium. No known surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939263
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4044 on: November 10, 2018, 04:29:45 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was having an increase in seizures up from 2-3 per day to up to 10 per day as well as wasn't able to feel stimulation. It was also reported to be having an increase in seizures during two appointments earlier in the year. Information was later received that the patient's system diagnostics were ok. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7962210
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4045 on: November 10, 2018, 04:30:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient had developed grand mal seizures that were increasing in frequency. Information was obtained from the physician office that the seizure frequency was around his pre-vns frequency. The cause of the increase was unclear per the physician as the patient stated that the are compliant with medications, didn't have an illness no illness or substance abuse, getting good sleep, and were avoiding triggers. The physician thought that this may be an evolution in the patient's epilepsy. Medication was prescribed for the increase in seizures. The most recent settings on an unknown date for the patient were reported to be: output current 0. 75/ frequency 15hz/ pulse width 250usec/ on time 7 sec/ off time1. 1 min/ autostim output current 1. 125ma/ heartbeat detection sensitivity 50%/ autostim pulse width 250usec/ autostim on time 60sec magnet output current 1. 375ma/ magnet pulse width 250/ magnet on time 60sec the impedance value on an unknown date was also reported to be 3623 ohms. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7971714
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4046 on: November 10, 2018, 04:30:56 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient experienced a moderate increase in seizure frequency related to the implant procedure of the vns device. It was also reported that the day before the increased seizures, the patient experienced severe nausea and vomiting related to the implant procedure. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8009286
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4047 on: November 10, 2018, 04:31:29 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/21/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had experienced an increase in seizures since being implanted with the vns which was described as the patient having "more and more seizures". No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7972038
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 52822


« Reply #4048 on: November 11, 2018, 02:51:09 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that this patient has been experiencing an increase in seizures and the patient's mother would like the patient to have their vns settings increased. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7927642
Logged
Pages: 1 ... 133 134 [135]   Go Up
Print
Jump to: