Pages: [1]   Go Down
Print
Author Topic: Mouth  (Read 1323 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« on: May 15, 2018, 08:06:56 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #1 on: May 15, 2018, 08:07:43 AM »

Model Number 102R
Event Date 11/04/2011
Event Type  Malfunction   
Manufacturer Narrative
Review of programming history. Event description, corrected data: previously submitted mdr indicated that surgery was likely; however, surgical intervention for the reported increase in seizures was not taken. This report is being submitted to correct this information.
 
Event Description
A response from the physician on (b)(6) 2012 did not provide information relevant to this event.
 
Event Description
Attempts for additional information have been unsuccessful. No surgical intervention for the increase in seizures was taken. A review of programming history on (b)(6) 2012 confirmed that normal mode and system diagnostics were within normal limits on (b)(6) 2012.
 
Manufacturer Narrative

Event Description
On (b)(4) 2012, clinic notes dated (b)(6) 2012 were received regarding this vns patient. Clinic notes dated (b)(6) 2012 indicated that since the patient's last clinic visit, ((b)(6) 2011), his seizures had overall been under stable control; however, for the past two months, he has had twitching and quivering of his lips followed by cessation of activity and staring then jerking of the left side of his body lasting a few minute. The frequency was variable; these occurred off and on all day or just a few times, but they tended to occur just prior to receiving his medication doses. The patient was not having any other seizure types and was not having any seizures at night, to the mother's knowledge. The settings from this date were provided. It was written that the patient was tolerating vns without adverse effects. During the appointment, multiple events o bilateral twitching/fluttering, twitching of lips and tongue lasting about 30 to 45 seconds were witness followed by a return to baseline. No stiffening or twitching or jerking of the extremities was noted. The vagus nerve stimulator was functioning properly and diagnostics indicated that the battery was sufficient although it was anticipated that the generator should be nearing end of service in the near future since the patient had the generator for nearly five years. No changes were made to the patient's settings. Clinic notes dated (b)(6) 2012 indicated that since the patient's last clinic visit ((b)(6) 2012), the patient's seizure control was stable. The patient continued to have a few ''small seizures'' daily described as twitching of his mouth and starting lasting a few seconds; these occurred just before his medications were due. The patient had not had any nocturnal generalized tonic-clinic seizures. The patient had near daily episodes of twitching of his shoulder lasting a few seconds; he was awake and alert during these spells without any seeming confusion. The patient's settings from this appointment were provided. The patient was still tolerating vns without adverse events. The patient's seizures were stable and under acceptable control. The vagus nerve stimulation is functioning properly, but diagnostics indicated that the battery was nearing end of service. The patient's mother expressed desire to have the vns replaced. Although she was not certain of its efficacy for seizures control, she felt the patient was more alert after vns was implanted and that seizures might be worse without the vns. Attempts for additional information will be made. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2728801
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #2 on: May 15, 2018, 08:08:31 AM »

Model Number 103
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated vns diagnostics for the patient's vns generator were within normal limits on (b)(6) 2012 with 2885 ohms, and the generator was not at end of service. The output current was increased from 1ma to 2ma at that time. The patient's medications were increased in (b)(6) 2012 to allow for greater seizure control, but the reporter felt the seizure increase was due to a depleting vns battery. The patient has also been experiencing behavioral issues since (b)(6) 2012. The patient was referred for generator replacement to preclude a serious injury that may result from either the increased seizures or behavioral issues if no improvement was seen. The patient had generator replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. Paperwork returned with the generator indicated the replacement was prophylactic.
 
Event Description
It was reported through clinic notes dated (b)(6) 2012 that patient was experiencing a new seizure variation tonic posturing then bends forward at waist then back up for the past 3 weeks. The patient's mother indicated that this was the worst seizure type seen in 20 years. Follow-up was made with the treating physician and it was indicated that upon checking function of vns, battery icon showed 25% life remaining. The new seizure was believed to be associated with low battery life. Additionally, increased activity could be related to decrease in output current on (b)(6) 2012 to maximize magnet benefit. At the moment, the patient has been referred to neurosurgery for battery replacement. Diagnostics at the office visit of (b)(6) 2012 indicated ok/2778/ok/no after a decrease in output current. However, diagnostics from the previous office visit ((b)(6) 2012) indicated eos=yes.
 
Event Description
Product analysis was completed on the returned vns generator. The generator was found to be at vbat

Event Description
Reporter indicated the patient's seizures had improved since the vns was replaced on (b)(6) 2012, and that the new seizure type has completely resolved since the vns replacement. The new seizure type was described as tonic posturing with bending forward, nostrils sucked in, and mouth clenched. The mother states the patient's seizures have improved since the replacement. The reporter stated vns has helped the patient's behavior as well.
 
Event Description
All further attempts to the reporter for information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2629599

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #3 on: August 26, 2018, 01:35:30 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported to the mfr by a caregiver that six months following vns implantation, the pt's mucus had gotten really thick and gummy. The pt has also developed a lot of bacterial problems such as bronchitis and mouth sores. The bronchitis was treated with antibiotics. The pt's caregiver was suggested to use the magnet to temporarily disable the device to see if the pt's mucous gets better. It is unk if vns therapy caused or contributed to the reported event. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1772211
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #4 on: October 15, 2018, 11:45:02 AM »

Model Number 102
Event Date 07/27/2012
Event Type  Injury   
Event Description
A vns treating physician in (b)(6) reported to our country representative that they had a vns patient who felt electrical pulses in the neck area. The physician reported that a burn had been seen in the patient's mouth upon exploration. Good faith attempts are underway for further information in regards to the reported event and confirm device function. The relationship to their vns is unclear at this time. It is unknown if the patient consumed a hot beverage or has some other kind of mouth trauma from another cause.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2711693
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #5 on: October 16, 2018, 03:07:05 PM »

Model Number 106
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient stated she has been having a burning sensation under her skin where the vns generator was placed and had a burn mark. It was reported that the issue has been going on for a while (exact date not reported). The patient's mother also mentioned that she can sometimes smell a burning smoke smell coming from the patient's mouth when she talks. It was also reported that the patient feels the generator gets warm whenever it is interrogated. Additional information was received that the patient's device was disabled on (b)(6) 2016 due to persistent chest pain, and the patient was also referred to a surgeon for evaluation. The chest pain did reportedly resolve once the patient's device was disabled. No additional relevant information has been received to date.
 
Event Description
The patient consulted another physician, who believes that the patient's events are due to the placement of the device as opposed to the device itself. The patient complains of constant pain around the superior portion of the chest incision and at the neck incision where the electrode appears to course above the platysma muscle. The discomfort appears to be related to the fact that the implant was placed too superficially, such that it is in direct contact with the dermis and is irritating the skin. The patient states that these symptoms have been present since the device was placed. During stimulation, the patient was extremely uncomfortable and noted the following symptoms: sensation of tasting something burning, pulling sensation in her neck, burning sensation in the neck and near the generator, coughing and nausea. There was no discoloration or heating of the skin around the generator that the physician observed. Per the physician, the above symptoms would be most consistent with inadvertent placement of the device on the hypoglossal or glossopharyngeal nerve instead of the vagus nerve, or potentially placement too superiorly on the vagus, or current spread to those nerves,. Per the physician's opinion, these are not necessarily indicative of a malfunction in the device itself. In addition, the recorded impedance of the device was 2183 ohms confirms no lead related issues. Per the implant operative report, the lead was implanted on the vagus nerve near the jugular vein and carotid artery. No other relevant information was obtained from the operative report as to the cause of pain. Patient underwent full revision surgery on (b)(46 2016. The explanted products were not received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5405291
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #6 on: October 18, 2018, 02:03:44 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #7 on: December 05, 2018, 01:24:37 AM »

Model Number 102
Event Date 03/29/2013
Event Type  Injury   
Event Description
Attempts for additional information did not provide information regarding the events. The only information returned was that the patient did not have a history or diagnosis of osa.

Manufacturer Narrative

Event Description
Operative notes from the patient¿s (b)(6) 2013 implant surgery were received. The procedure was completed with minimal blood loss. No adverse events or complications were noted in the operative report. It was noted that the programming wand was used to interrogate and test the generator and lead, and they tested well.

Event Description
Clinic notes dated (b)(6) 2013 indicates that the patient was seen for follow up after vns placement performed on (b)(6) 2013. The patient reports hoarseness that waxes and wanes, and is concerned about "feeling the wiring up in the lower neck". The patient had some throat, tongue, and perioral numbness a couple of days ago, but it resolved. The notes also mention that the patient has a past medical history or sleep apnea. Clinic notes dated (b)(6), 2013, indicate that the patient feels like something is "stuck in his throat when the vns is on" and feels like he is choking while eating. The patient went in for revision surgery on (b)(6) 2013, where the lead, and possibly the generator, were revised or repositioned. The devices were not removed and no new devices were implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
Operative notes from the patient¿s (b)(6) 2013 surgery were received. Surgical diagnoses included painful malpositioned vagal nerve stimulator lead. During surgery, robust fibrotic scar tissues was found with suture tie downs dislodged. The note stated that the patient tolerated the initial implant procedure well; however, he began to complain of left neck superficial pain at the site of palpable scar tissue and lead. Initial non-operative management included massage and external repositioning, which were both unsuccessful. X-rays reportedly showed no fracture of the lead. During surgery, the suture tie-downs were noted to have become dislodged. The suture tie-downs were temporarily removed, and the lead was freed as much as possible and then re-secured. The lead course was re-routed to allow gentle curve with strain relief loop recreated and suture tie downs secured to muscular fascia. Scar tissue was revised.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3292790
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #8 on: May 20, 2019, 09:47:10 PM »

Model Number 101
Event Date 11/11/2008
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The physician did not have any additional relevant information. The cause and date of death are unknown. The relationship of the cause of death to vns is unknown. No additional relevant information has been received to date.
 
Event Description
Hospital records were received indicating that the patient's primary diagnosis was status epilepticus. The secondary diagnoses were listed as disseminated intravascular coagulation, cardiopulmonary arrest, seizure disorder, hydrocephalus, respiratory failure, mental retardation, and cerebral palsy. The patient's past medical history was listed as seizure disorder, hydrocephalus with vp shunt, (b)(6) status post decompression and mrcp. It was noted that the patient was found during sleep to have seizure activity and diastat was given with no improvement. The patient was brought to the emergency room with fever, increased heart rate to 200 and low blood pressure (74/42). Labs were taken and the patient had an increased pt, ptt and inr. Blood gases showed the patient was acidotic and having worsening respiratory distress including metabolic and respiratory acidosis so the patient was intubated. The patient became hypotensive and bleeding from the mouth. The patient developed large hematomas at multiple sites where blood was drawn. The patient received fresh frozen plasma and was placed on ventilator support. Metabolic acidosis continued and the patient was given sodium bicarb. The patient's heart rate dropped and the patient became pulseless. Cpr was initiated along with defibrillation. The patient's family requested withdrawal of support.
 
Event Description
The patient's online obituary indicated that the patient passed away at the hospital. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.
 
Manufacturer Narrative
Corrected data: this information was inadvertently left off of follow-up mfr. Report #01.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164211
Logged
Pages: [1]   Go Up
Print
Jump to: