Pages: 1 2 3 [4]  All   Go Down
Print
Author Topic: Armpit  (Read 17814 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #90 on: November 10, 2018, 03:41:00 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/27/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's generator has moved laterally almost into the axilla and is causing itching and pain. Information was obtained from the implanting physician that absorbable sutures, 2. 0 prolene, were used during the implant procedure. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7994752
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #91 on: November 10, 2018, 03:41:39 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Injury   
Event Description
Information was received that the patient generator had moved into the left axilia. Additional information was received from the surgeon's office that absorbable sutures were used. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7984832
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #92 on: December 07, 2018, 09:24:04 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to the vns generator.

Event Description
It was reported by the patient that their generator had migrated into her armpit. The patient was experiencing adverse events related to the generator migration such as pain around her collarbone and ribs. The patient also reported that she had lost a bit of weight. The patient was referred for surgery. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8095773
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #93 on: December 10, 2018, 03:19:16 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury  
Event Description
It was reported that the patient was referred for vns explantation surgery due to irritation along the chest and left axilla, which the patient attributed to the vns. The vns was previously disabled for reasons unrelated to the vns. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8091038
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #94 on: December 14, 2018, 06:43:49 AM »

Model Number 105
Event Date 08/12/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).

Event Description
It was reported by the physician's office that the patient was admitted to the hospital due to infection. The patient was going to be replaced; however, the site did not have a replacement generator and needed a company representative to provide one for the replacement. A company representative later confirmed he attended the replacement surgery on (b)(6) 2016. He confirmed the patient's generator was replaced due to infection and the new generator remained programmed off. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The explanted generator was received by the manufacturer for analysis. Product analysis is expected, but has not been completed to date.

Event Description
Product analysis (pa) for the returned generator was completed. While the reported infection is beyond the scope of the activities performed within the pa lab, the potential contributing factors have been considered and evaluated and none were found to exist in the reported situation. The diagnostics for the generator were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

Event Description
It was later reported by the physician that the infection was first observed within the clinic on (b)(6) 2016. Due to this information, additional follow up was performed at which point it was explained that the patient had a subsequent infection and that the original infection was first observed on (b)(6) 2016. It was noted the family had called the physician's office on (b)(6) 2016 with a report of swelling, the patient went to the ed (emergency department) on (b)(6) 2016, and the generator device was replaced on (b)(6) 2016. During the replacement surgery on (b)(6) 2016, the chest wall was washed out and the patient was placed on a normal regimen of iv antibiotics. It was noted the believed cause of the infection was due to the placement of the device in the axillary region, as opposed to the chest, and the patient is in a wheelchair. It is felt that the sweat is a contributing factor in the wound getting infected. The information regarding the second infection has been reported in mfr. Report 1644487-2016-02467.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5942349
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #95 on: December 16, 2018, 04:03:36 AM »

Event Date 03/25/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the vns patient was complaining of pain in both incision sites that had started on (b)(6) 2013, but is working with her pain management doctor to get relief. The patient's vns had not yet been turned on. On (b)(6) 2013, the patient reported that on (b)(6) 2013, she noticed a small amount of "green cloudy" drainage from the "top" portion of her generator incision, left axilla. On (b)(6) 2013. The very top of the same incision "opened up", approximately 2mm, and there was no further drainage. The patient went to the emergency room and didn't tell them about the prior day's drainage and they just cleaned the incision and placed a gauze dressing over the incision. The patient stated that in the last week she has run a fever up to 101 twice, has taken ibuprofen and has had no fever for the last few days. The patient stated that the left axillary incision is red, swollen, and tender to the touch; pain scale of 7-8. The patient stated that she showered about the 4th day post-operation. The physician reported that the patient needs to go to the emergency room immediately because the vns could be infected and therefore, might have to be removed or revised. The physician later reported that the event was due to the patient's surgery and the only intervention planned was pain medications. The patient's generator was turned on. The surgeon is working with a local physician where the patient lives to follow-up on the patient's infection. Good faith attempts for the patient's implanted product information were made to the implanting hospital but the information has not been received to date.

Manufacturer Narrative

Event Description
Additional information received on (b)(4) 2013 when it was reported that the patient was doing much better and the incision site is healing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074526
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #96 on: December 19, 2018, 12:33:58 PM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the physician that the patient was seen on (b)(6) 2015 and the patient states she believed the device had migrated but she saw the surgeon and no surgery is needed as of (b)(6) 2015. No surgery or interventions that are known have occurred to date.

Event Description
It was reported by the patient that the generator had migrated towards her arm pit leading to the wrapping of the lead around her thyroid thus causing damage to her left vocal cord for which surgery would have to take place, specifically, removal of the left vocal cord. Attempts for further information from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4680987
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #97 on: December 22, 2018, 10:13:32 AM »

Model Number 103
Event Date 06/19/2013
Event Type  Injury   
Event Description
The patient's vns device was removed due to infection at the site. The infection was first observed on (b)(6) 2013. A wound swab from the left neck wound indicated staphylococcus aureus. This was treated with antibiotics. On (b)(6) 2013, there was revision and cleaning of the left axilla wound. Inflammatory exudate seen, but no pus observed. Treated with antibiotics. (b)(6) 2013 - inflammation of the left axilla wound. A wound swab showed staphylococcus aureus. The vns generator and lead were removed on (b)(6) 2013. Cloudy fluid was seen, but there was no obvious pus. Heavy growth of staphylococcus aureus seen and treated with antibiotics. The medical professional stated that the relationship of the infection to vns was likely an external cause. No patient manipulation or trauma was noted. The anatomical location of the infection was not thought to be a factor. Cultures confirmed staphylococcus aureus. No other information was provided.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3538529
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #98 on: January 04, 2019, 09:28:34 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #99 on: January 04, 2019, 09:29:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain at the generator site, which was at the left armpit due to a chest tattoo. The device was causing discomfort due to being much larger (m106) than the patient¿s previous m103. The patient has a follow-up appointment with the surgeon to discuss moving the vns generator. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8181673
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #100 on: January 15, 2019, 02:56:13 AM »

Model Number 102
Event Date 04/10/2014
Event Type  Injury   
Event Description
It was reported that the patient's generator is more towards his axilla than before and there has been some questioning if this is due to the patient's activity at the gym along with fighting with his brother. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
The patient underwent surgery at which time it was noted that there was no evidence that the generator had migrated. It was noted that the implanting surgeon inserted the generator through the axilla.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3809026
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #101 on: January 20, 2019, 03:12:08 AM »

Model Number 103
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.
 
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.
 
Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.
 
Event Description
Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.
 
Manufacturer Narrative
Only the generator was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #102 on: February 07, 2019, 02:23:37 AM »

Model Number 300-20
Event Date 11/10/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted devices were discarded after surgery. Therefore, analysis is unable to be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance (10,000 ohms). There was no trauma or manipulation that occurred that is believed to have caused or contributed to the high impedance. The device was programmed off and the patient was referred for surgery. Further follow-up revealed that the patient had undergone generator replacement on (b)(6) 2014. It was reported that device diagnostics on (b)(6) 2014 were within normal limits (3554 ohms). The patient was seen again on (b)(6) 2014 and device diagnostics were again within normal limits (3621 ohms). The physician assistant indicated that the generator was located in the axilla region and there was a possibility that the placement of the generator has caused the lead pin to become dislodged or the flexion of the patient's arm may have caused a fracture. X-rays were taken and it was reported that no lead discontinuity was identified. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4316945
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #103 on: February 07, 2019, 02:24:19 AM »

Model Number 104
Event Date 02/25/2014
Event Type  Injury   
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.
 
Event Description
Initially, it was reported that the patient was experiencing a shocking sensation with device stimulation following generator replacement. It was reported that device diagnostics were within normal limits. The physician indicated that the patient may be referred for lead replacement. It was later reported that the patient was referred for generator and lead replacement at the patient's request. No additional relevant information has been received to date. Surgery is planned, but has not occurred to date.
 
Event Description
The patent had generator pocket revision on (b)(6) 2015. The surgeon moved the generator from the armpit area and into the front chest area below the collarbone. While moving locations, he decided to replace the generator in the process due to the patient's complaint of shocking sensations. The explanted generator was discarded. Therefore, analysis is unable to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4441302
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #104 on: March 14, 2019, 06:10:56 AM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported on (b)(6)2015 that the patient¿s incision is starting to open and the patient¿s mother thinks she can see the lead wires. The patient¿s most recent vns surgery was a full revision on (b)(6) 2014 (captured in file (b)(4)). The mother first noticed it appeared ¿bubbly¿ on (b)(6) 2015 and the physician put the patient on antibiotics. Things then seemed better. However, the morning of (b)(6) 2015 the patient¿s crusty scab fell off and now the patient¿s mother thinks she can see the lead. The patient¿s physician noted that the extrusion was located at the left axilla. He noted that the patient¿s previous re-implants of generators through the initial axillary led to the battery migration laterally to incision twice (b)(6) 2014 and (b)(6) 2015. The physician indicated that the patient has generalized seizures where the patient strikes her chest and has a tendency to pick at the incision line. The first dehiscence was in (b)(6) 2014 and was treated with antibiotics and the generator was placed deeper with layered closure to prevent migration. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the extrusion. There was no infection, just exposure to surface bacteria. Cultures showed results of skin flora, ¿staph epi¿.
 
Event Description
Additional information was received that the patient's lead wires were coming out of the patient's arm pit incision site. The generator is in place but the excess lead has migrated to the arm pit and is extruding from the old incision site. Patient underwent surgery to reposition the lead wires on (b)(6) 2016. Patient manipulation is not suspected to be the cause. According to the surgeon, patient's vns device was originally implanted under the pectoral muscles and generator was in the armpit. In (b)(6) 2015, the leads had extruded out of the skin and the surgeon had gone in and moved the generator to a new location in the chest. He did not move the leads due to risk of damaging it and just routed the leads to the generator in the new location. However now, some of the leads is again extruding out of the skin in the old generator location. He suspects that the contractions of the pectoral muscles are what caused the leads to be pushed and extruded out for both times. The surgeon went back into the area of the extrusion and pushed the leads in further and cleaned out the area. Device was not even taken out of the body and no replacement of products took place. No visible infection was seen. Diagnostics performed afterwards showed everything was ok with 2611 ohms and ifi=no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159327
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #105 on: March 16, 2019, 02:00:03 AM »

Device Problems Generator; High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device had returned high impedance upon diagnostics in (b)(6) 2015. The patient¿s generator was implanted in the axilla. The patient had been implanted in (b)(6) 2014 with a generator model 102. It was reported that the vns therapy had yielded benefit for the patient. In (b)(6) 2015 system and normal mode diagnostics were run and they returned impedance within normal ranges, with dcdc2 and dcdc3 respectively. Diagnostics performed early in (b)(6) 2015 returned high impedance. The patient underwent a generator replacement in mid (b)(6) 2015 with a generator model 103. No x-rays were taken. Diagnostics were run in (b)(6) 2015 on the generator model 103 and they returned high impedance with 9000 ohms. The patient¿s settings at the time were programmed at 2ma, 30sec on-time, 5 min off-time. Diagnostics were run on (b)(6) 2015 which returned high impedance 5000 ohms. The patient¿s generator was not switched off upon parents request as it is believed that the patient is still having benefit from vns. A lead surgical revision is expected but it has not been confirmed to date.
 
Event Description
Further information received indicates that the device was disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5133935
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #106 on: April 06, 2019, 01:41:30 AM »

Model Number 106
Device Problem Corroded
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle. The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site. The patient was admitted to the hospital and given antibiotics. The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out. It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. The explanted suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #107 on: April 07, 2019, 02:42:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient has a wound infection of the left axilla. Additional information was received that the patient first presented with the infection with an aching in their left axilla. The majority of the infection was located at the wound site, but the physician thinks the infection expanded to the generator area, but the wound site was not open. It was stated that this patient has diabetes with poor glycemic control, and therefore is at increased susceptibility to infection. Therefore the physician thinks the bacteria might be penetrated from the wound site at the left axilla and expanded to the generator area. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No known surgical intervention has occurred to date. No further relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424229
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #108 on: April 09, 2019, 12:48:28 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.
 
Event Description
Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697512
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #109 on: April 15, 2019, 01:29:46 AM »

Model Number 103
Event Date 04/22/2016
Event Type  Injury   
Event Description
On (b)(6) 2016, patient mentioned that she thinks the generator is drifting more laterally on her chest wall. X-rays were taken and was reported to be intact per the physician. Further attempts to learn whether non-absorbable suture was used to secure the generator in place on (b)(6) 2012 were made but were unsuccessful to date. Clinic notes were received for patient's referral for prophylactic generator replacement with the intention of addressing the generator migration at that time. Clinic notes stated that the patient's generator is dislodged from the pocket and is projecting through the skin in the armpit. The patient was referred for surgery to reseat the generator in the pocket. The device was checked and was confirmed to be working fine. The settings were increased as patient feels that she is experiencing breakthrough auras and seizures. Patient underwent prophylactic generator replacement on (b)(6) 2016. The explanted generator will not be returned to manufacturer by the hospital. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the patient did experience an increase in seizures and auras but its below pre-vns baseline and is not believed to be related to vns. This will not be captured/coded as a result. The physician is uncertain on the cause of device migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5853731
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #110 on: April 29, 2019, 05:56:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #111 on: May 03, 2019, 02:01:07 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #112 on: May 07, 2019, 07:19:17 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue. Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator. It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge. The patient denied fever, chills, or any change in status and the generator was still functional. Subcutaneous fluid collection and swelling were also noted at the generator site. The patient was referred for explant of the generator and the lead. It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient underwent vns explant on (b)(6) 2017. The physician did not know the cause of the migration.
 
Event Description
It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6398375
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #113 on: May 18, 2019, 12:59:20 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2015
Event Type  Injury   
Event Description
It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin. The patient mentioned that her device had been like this for two years. The patient's generator later migrated to her armpit and was causing her pain. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.
 
Event Description
The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to. The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration. The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator. As such, the physician believed that the generator must have fallen down on its own. The physician planned to resolve the protrusion and migration during replacement surgery. The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient underwent full revision surgery. The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6452971
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #114 on: May 27, 2019, 11:17:35 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was complaining of pain around the vns in the chest and left shoulder. The pain occurred when the left chest area was touched. The patient was referred to a surgeon for further evaluation, including a ct of the left chest, an emg, and x-rays of the ribs without a possible cause for pain shown. There was no infection or any problems seen in the left chest. The patient was subsequently referred for explant surgery with relation to the tenderness over the left armpit and vns chest site. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Further information was received from both the patient¿s treating neurologist and surgeon that showed the surgery was not to preclude a serious injury. The patient¿s generator was subsequently explanted in surgery. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6653715
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #115 on: July 30, 2019, 10:31:14 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the device extrusion is not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient reported discomfort following vns implant. The patient reports that they could see the vns generator and lead coming out of their skin. They also stated that they can feel the device sliding and moving close to their armpit. No known surgical intervention has occurred to date for the generator or lead. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8277830
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #116 on: August 10, 2019, 01:16:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported migration is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was referred for re-positioning surgery due to generator migration that was causing discomfort for the patient. It was reported that the generator had migrated to under the patient's axilla on the left side and that there was tenderness to palpation. No known relevant surgical intervention has occurred to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8776206
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #117 on: September 06, 2019, 10:48:41 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received for the surgery referral of a patient desiring to have the vns system explanted. The clinic notes were reviewed and state that the patient was initially referred due to discomfort at the vns generator location. The neurologist had recommend neurosurgery to evaluate the location of the vns generator to see if it can be moved more medially to relieve patient's pain. During the consultation appointment, the surgeon noted that the patient has tenderness where the generator is located and the generator is slightly protruding from their left armpit. During consult, the patient went on to report that the vns device has not helped their seizures and has actually made them worse, stating that the seizures occur more frequently than prior to the device being implanted. The patient also reports having new ¿double¿ seizures that occur in clusters. The patient also noted that their memory has been worse than before vns. The patient wants to the vns device removed as it has not provided any benefit and noted that the magnet does not help with her seizures either. It was also mentioned that the neurologists notes have not reported the vns worsening the patients seizures, but the patient stated otherwise. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8888575
Logged
Pages: 1 2 3 [4]  All   Go Up
Print
Jump to: