Pages: 1 ... 11 12 [13]   Go Down
Print
Author Topic: Painful Stimulation  (Read 14376 times)
0 Members and 3 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #360 on: January 05, 2019, 03:10:03 AM »

Model Number 105
Event Date 04/28/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance. Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve. Bradycardia was observed as intended and resolved without intervention. Therefore, it was concluded that the electrodes were properly placed. The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system. As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3825172
« Last Edit: January 14, 2019, 07:59:21 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #361 on: January 05, 2019, 03:11:20 AM »

Model Number 103
Device Problem Fracture
Event Date 11/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient's device was showing high impedance. The patient was sent for x-rays of her neck and chest. The device settings were lowered and it was stated that the device was not bothering her after that; so the device was not turned off during the visit. Further updates were received noting additional diagnostics performed on the patient's device. Two diagnostics were performed confirming the high impedance. It was stated that the device was intended to be turned off due to painful stimulation in the neck. The patient had also reported that her neck locks up at times to the left side. After device settings were adjusted, the patient was concerned that fully disabling her device would lead to increased seizures, so the settings were kept at the lower output. The patient reported no longer feeling pain with the new settings. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141647
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #362 on: January 05, 2019, 03:11:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported experiencing an increase in seizures and painful stimulation. Further information was received that the patient is referred for replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8150439
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #363 on: January 06, 2019, 11:01:42 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/06/2018
Event Type  Injury   
Event Description
The patient reported that they experienced an increase in seizure frequency due to the low battery of the generator. The physician attributed the patient's increase in seizure frequency to battery depletion. Per the physician, the patient also indicated that she experienced pain, with and without stimulation, all over her body that worsened with stimulation. The patient stated that the pain was due to the low battery of the generator as well. The physician indicated that the patient was referred for generator replacement due to patient comfort. The manufacturer's battery life estimation tool was unable to verify battery depletion based on the available patient programming data. No relevant 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=8122322
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #364 on: January 08, 2019, 07:56:20 AM »

Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. 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. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3701858
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #365 on: January 08, 2019, 07:57:09 AM »

Model Number 105
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized for an increase in seizures that began the week prior. It was reported that the patient has experienced about 60 seizures over the past week. It is unknown if the increase in seizures was above the patient's pre-vns baseline frequency. It was reported that the patient was also experiencing painful stimulation at the electrode site that improves with pressure applied to the site. The physician decreased the patient's settings; however, this did not resolve the patient's pain. The device was later disabled. It was reported that device diagnostics were within normal limits (1326 ohms). The physician reported that he wanted to prophylactically replace the lead since it is 10 years old. X-rays were taken, but the results were not provided to manufacturer. It was reported that despite the diagnostics being within normal limits the physician still believes the painful stimulation and increase in seizures are due to a lead issue. It was reported that there was no trauma, medication changes or other recent changes that could have causes the increase in seizures and painful stimulation. Further follow-up revealed that the patient was airlifted to a hospital in a bigger city and it was decided to not replace the patient's lead. The patient's medication was adjusted and the vns was programmed back on and ramped up to 1ma output current. The physicians would not provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606770
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #366 on: January 09, 2019, 09:06:06 AM »

Model Number 105
Event Date 01/25/2014
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677841
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #367 on: January 09, 2019, 09:06:44 AM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Additional information was received stating the neck pain was the reason for the replacement surgery. The patient began experiencing the pain around (b)(6) 2013. The pain occurred with stimulation and ceased when the magnet was used to disable the device. Diagnostic results revealed lead impedance to be within normal limits (impedance value ¿ 3114 ohms). Causal or contributory programming or medication changes did not precede the onset of the pain. The epileptologist stated that a thyroid lesion may have contributed to the pain. The pain resolved when the device was programmed off and did not recur when the replacement device was programmed on. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: the date received by manufacturer was incorrectly reported on the initial manufacturer report. The date should have been (b)(4) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3675824
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #368 on: January 10, 2019, 02:12:50 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3666903
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #369 on: January 10, 2019, 02:13:37 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity and battery depletion. It was reported that the explanted devices were sent to pathology and disposed of. No product analysis can be performed.
 
Event Description
It was reported that x-rays were performed because the patient's device was not working. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. Further follow-up with the physician identified that high impedance (dc dc code - 7) was observed. It was reported that the patient had complained of discomfort and burning at the back of the throat. It was reported that device frequency was reduced from 25hz to 20hz for the discomfort. The patient reported that the discomfort and burning began approximately two months prior and occurs with device stimulation. The patient mentioned that the pain and burning worsens when moving the head from side to side. The patient denied and trauma that may have caused or contributed to the high impedance. The physician reported that the device was programmed off and the patient would be referred for surgical consult. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3782517
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #370 on: January 11, 2019, 03:04:54 AM »

Model Number 102
Event Date 09/28/2006
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the patient experiences painful stimulation that started two weeks prior. The patient has not experienced any trauma to the neck area. The neurologist reviewed x-rays and reported that nothing unusual was noted. The patient was referred for surgery. The physician reported that the device was programmed off after observing the high impedance. The physician reported that x-rays would not be sent to manufacturer for review. Surgical intervention has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent surgery and that only the generator was replaced. It was reported that the generator was discarded after the surgery and would not be received for analysis. Attempts to obtain additional relevant information have been unsuccessful to date. It appears that the high impedance resolved with generator replacement since only the generator was replaced indicating a likely generator/lead connection problem.
 
Manufacturer Narrative
Date of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Operator of device, corrected data: supplemental manufacturer report #01 inadvertently did not update this information.
 
Manufacturer Narrative
New information changes the suspect device.
 
Event Description
Additional information was received indicating that the vns patient¿s generator replacement resolved reported high impedance. The replacement device was tested with the existing lead multiple times and showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3761805
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #371 on: January 12, 2019, 12:26:45 AM »

Model Number 103
Event Date 02/25/2014
Event Type  Injury   
Event Description
Operative notes from the surgeon reported that because of intermittent painful stimulation, there was concern of a microfracture of the lead or a generator issue. The patient also believed something was wrong with the device. No further relevant information has been received to date.
 
Manufacturer Narrative
The initial portion of the event description in supplemental mdr 2 was corrected as supplemental mdr 2 inadvertently implied that it was alleged that the motor vehicle accident had caused the painful stimulation in (b)(6) 2014 for which intervention had occurred.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial manufacturer report inadvertently did not specify that the patient¿s fall may have ¿dislodged¿ the device again.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient fell off a horse on (b)(6) 2014. During an office visit the following day, the patient reported pain occurring with stimulation. The device was subsequently programmed off but the pain persisted. Diagnostic results revealed normal device function at the time. The patient underwent generator and lead replacement surgery due to pain on (b)(6) 2014. The patient's pain had resolved since the replacement surgery, which was performed as a precaution and for patient comfort. The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The patient's mother reported that the patient first time the patient had experienced painful stimulation was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful didn't have painful stimulation again until (b)(6) 2014, which was already reported as when the patient fell off her horse, and the patient was instructed to tape the magnet over the generator to disable the device.
 
Event Description
The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device again. It is unclear when the previous occurrence was as a previous report of painful stimulation subsided with device disablement. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. 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. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Review of the decoder data did not reveal any anomalies. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
The patient's mother reported that the patient was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful stimulation did not occur until (b)(6) 2014 and the patient was instructed to tape the magnet over the generator to disable the device. The following day, the patient was seen by the physician. The physician removed the magnet and the patient again experienced painful device stimulation. The device was programmed off for three days and when programmed back to on, the patient again experienced painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3735544
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #372 on: January 12, 2019, 12:28:37 AM »

Model Number 103
Event Date 03/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the generator was replaced prophylactically and that the migration of the device was believed to be due to the trauma from the patient falling off of the porch. The increase in seizures was reported to be not related to vns. The patient was reported to be doing "fine" since generator replacement and no longer experiencing the reported events.
 
Event Description
It was reported that the patient suffered a fall off of the front porch which resulted in injury to her left neck. The patient indicated that she began experiencing an increase in seizures. It was reported that the patient began experiencing painful stimulation the night of the fall after she felt something "snap" while laying in bed. It was reported that the patient also began experiencing pain in her chest around the generator and felt as if the generator had slipped down lower toward her breast. The patient was awaiting scheduled prophylactic battery replacement at the time of the fall; however, the physician wanted to get the patient to surgery sooner as a result of the events. The patient underwent generator replacement. It was reported that pre-operative device diagnostics were within normal limits (2323 ohms). The generator was replaced and diagnostics were again within normal limits (2048 ohms). It was reported that the explanting facility does not return explanted devices; therefore, no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3757141
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #373 on: January 12, 2019, 12:30:02 AM »

Model Number 103
Event Date 03/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing pain on the left side of her neck with magnet mode stimulation while being able to tolerate normal mode stimulation. Changes to the patient¿s programmed settings were unsuccessful in resolving the pain. The patient had a surgical consultation on (b)(6) 2014 to plan interventions to preclude a serious injury and for patient comfort. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the neurologist and the surgeon indicated that the lead looks ok and they aren't going to do anything further.
 
Event Description
It was reported that the patient is having a consult with the neurologist regarding the vns. Interrogation during consult showed that the generator has 50% battery and therefore there are no plans for surgery currently. Diagnostics were reported to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3735489
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #374 on: January 14, 2019, 04:22:39 AM »

Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #375 on: January 16, 2019, 02:53:27 AM »

Model Number 101
Event Date 03/01/2014
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic generator replacement. It was reported that preoperative and postoperative device diagnostics were within normal limits (dc dc code - 2). It was reported that the patient has not yet been seen for follow-up with the neurologist since the surgery. It was reported that the explanting facility discarded the explanted generator; therefore analysis cannot be performed.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Additional information was received stating that the vns patient had a big aura on (b)(6) 2014. The patient became light-headed and was diaphoretic. The patient swiped her magnet but it did not help her aura. The patient stated that her previous auras were similar but not back up to pre-vns baseline levels. The patient did not have any auras after (b)(6) 2014. The patient also reported that her vns stimulation was no longer as strong as it was in the past. The patient¿s pre-operative evaluations had been completed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3804675
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #376 on: January 16, 2019, 02:54:36 AM »

Model Number 105
Event Date 04/11/2014
Event Type  Injury   
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the patient¿s issues were noted on (b)(6) 2014.
 
Manufacturer Narrative

Event Description
Additional information was received indicating that the vns patient¿s pain and rash was noted on (b)(6) 2014. The neurologist stated that the patient was too thin and that the device was bothering her. The patient¿s device was disabled but the patient¿s issues did not resolve. The patient¿s will be explanted for patient comfort but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received. Clinic notes dated (b)(6) 2014 from surgery consult reported that the patient's generator was causing more pain and weakness than her previous device due to the size, which was worse if it was manipulated. The surgeon advised that the device was likely not the source of all of her pain and does not expect all of the pain to resolve after removal. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the patient has been complaining of painful stimulation and a rash at the generator site. The patient is going to see surgeon for device explant. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3801005
Logged
Pages: 1 ... 11 12 [13]   Go Up
Print
Jump to: