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dennis100
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« Reply #570 on: May 10, 2019, 02:09:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2019
Event Type  Injury   
Event Description
It was reported by the patient that their generator pocket had ripped and the generator was lower than it should be following the patient lifting a heavy object. The patient reported that when they went under an overpass they believed the magnetic force of the wires in the overpass caused paralysis of their vocal cords, caused their lead wire to become taut, pain in neck, and their voice to become hoarse. The patient indicated that their neck was bruised and swollen from the stimulation that occurred due to the overpass and felt like their leads were going to come out of their neck. The surgeon's office indicated that the entirety of the reported adverse events experienced by the patient were related to the migration of the generator. It was reported that the generator was secured during initial implant surgery using a "butterfly wing" suture technique; however, the type of suture was not known. It was reported that the patient was referred for a pocket adjustment. No known 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=8562974
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dennis100
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« Reply #571 on: May 10, 2019, 02:10:24 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Event Description
Patient's generator was unable to interrogate and previously reported to have prematurely depleted (captured in mfr. Report # 1644487-2019-00328). Further information was received that it was unknown if the battery was dead or if there was a problem with the lead. The patient reported having neck pain. The patient was referred for device 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=8473128
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dennis100
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« Reply #572 on: May 10, 2019, 02:10:59 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient's generator was explanted due to the device hurting them and not wanting it anymore. Product analysis was completed on the returned lead and generator. For the lead, the anchor tether helical and a small portion of quadfilar coil, and the (+) white and (-) green electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was 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 portions were performed, during the visual analysis, and no discontinuities were identified. For the generator, the septum was not cored. The device's output signal was monitored for more than 24-hours in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the expected level of output current during the monitoring period. Diagnostics were as expected for the generator and an automated electric evaluations showed the generator performed according to functional specifications. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8560083
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dennis100
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« Reply #573 on: May 11, 2019, 03:02:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2014
Event Type  Injury   
Event Description
The patient was referred for vns generator replacement to move their generator back to their left side. The patient had most recently been implanted on the right side, which caused pain in neck when making settings adjustments, wheezing / shortness of breath, and less efficacy than the left side due to the inability to titrate the generator to therapeutic settings. It was reported that the adverse events experienced by the patient were due to the vns stimulation when settings were increased and that the adverse events did not occur previously when the generator was implanted on the left side. 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=8527189
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dennis100
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« Reply #574 on: May 11, 2019, 03:03:14 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
It was reported that the patient experienced pain at generator site following their generator replacement surgery. The patient was referred for generator re-positioning surgery due to their discomfort. It was also reported that the patient's discomfort was preventing them from having a mammogram due to possible breast cancer and that the vns generator had migrated to the areola, causing the discomfort. No known 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=8527920
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dennis100
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« Reply #575 on: May 14, 2019, 01:22:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/11/2015
Event Type  Injury   
Event Description
It was reported the patient's vns generator had reached normal ifi = yes (intensified follow-up indicator) and she was referred for normal replacement surgery. However, it was also noted that the device was mobile and causing the patient discomfort. The patient reported she sleeps with a blanket on her chest to keep the generator in place. The migration will be resolved at the time of the replacement surgery. The device diagnostics have been checked and it was noted the device is working as intended as all diagnostic results were within normal limits. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device evaluated by mfr, (b)(4). Device evaluation is not necessary because the reported migration has been determined as not related to vns therapy.
 
Event Description
It was reported the patient underwent vns generator replacement surgery due to normal battery depletion and to reposition the generator due to discomfort that was caused when the generator had migrated. The generator was received by the manufacturer. While analysis is expected, it has not been completed to date.
 
Event Description
Product analysis (pa) for the returned generator was completed. It should be noted that the reported migration and pain are outside the scope of the pa laboratory. However, proper functionality of the vns generator in its ability to provide appropriate programmed output currents can be verified. This was successfully verified in the pa lab. There were no performance or any other types of adverse conditions found with the vns generator. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6474087
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dennis100
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« Reply #576 on: May 14, 2019, 01:23:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/24/2017
Event Type  Injury   
Event Description
It was reported that a patient had redness, pain, and swelling at her incision site a few weeks after surgery. The site was reportedly fine 7 days after surgery. The patient was administered antibiotics and was reportedly doing a little better. The patient then had an ultrasound performed and her site was still infected after the antibiotics. The manufacturing record for the implanted generator confirmed proper sterilization prior to release for distribution. No known surgical intervention has taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6484987
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dennis100
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« Reply #577 on: May 18, 2019, 01:01:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Manufacturer Narrative
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 a generator pocket revision surgery was scheduled for the patient. The patient reported that she felt like there was a little movement within the pocket, so the physician planned to perform exploratory surgery. Follow up with the office of the surgeon showed that the generator movement was first noted by him in an office visit. Review of the operative report from the patient¿s previous generator implant surgery did not show a reference to the generator being sutured within the pocket. In the consult appointment, the surgeon noted that the generator did have some mobility within pocket and moved slightly to the left. It was assessed that the generator was causing left chest and arm pain via physical irritation to the pectoralis and biceps muscles. The patient and caregiver requested the surgeon to move the generator medially. Surgery to reposition the generator was completed as planned. In this surgery, the surgeon placed a non-absorbable suture to secure the generator within the pocket. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572484
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dennis100
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« Reply #578 on: May 18, 2019, 01:02:10 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by an er physician that the patient was seen in the er due to feeling the device constantly going off. The magnet was placed over the generator to disable the device and it was stated by the patient that the stimulation did not stop. It was later reported that the magnet did disable the device and that the patient had vocal cord paralysis, chocking, and hoarseness with vns stimulation. There was also pain reported that occurred when the device was on and off. The patient did not want the device disabled so the only settings change was the lowering of the on time. The diagnostics for the device were reported to be ok when the patient was in the er. The patient went in for a follow up visit with the neurologist and the diagnostics were again ok. The neurologist believes the issues are due to the patient taking longer to recover from the vns surgery or possibly a psychosomatic event caused by anxiety with vns stimulation. X-rays were performed, and a review by the physician revealed no issues. No additional relevant information has been received to date.
 
Event Description
It was later reported that no surgical intervention was planned to address the adverse events and that the vocal cord paralysis had resolved. The only continuing complaint was the choking sensation the patient was experiencing. X-rays were reviewed by the manufacturer which revealed no issues with the device that would result in the adverse events experienced by the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569513
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dennis100
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« Reply #579 on: May 18, 2019, 01:02:50 AM »

Model Number 300-20
Device Problem Fracture
Event Date 04/14/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit on high impedance was observed as a result of a diagnostic test. The settings were not changed at that time. The patient reported that for the past 1-2 weeks she had been experiencing an increase in seizures and left jaw discomfort. She also had been stuttering for the previous 2 days and the vns magnet was not working the same as before. The patient was referred for surgery to address the high impedance but no surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6584365
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dennis100
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« Reply #580 on: May 18, 2019, 01:03:30 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
A physician reported that a patient underwent a full replacement surgery due to pain in the chest and neck. The physician indicated that the device had not been working for a few months prior to the replacement. The system diagnostic test showed normal values and patient had an emg-based test that showed good values. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600631
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dennis100
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« Reply #581 on: May 18, 2019, 01:04:08 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/27/2017
Event Type  Injury   
Event Description
It was reported that the patient's device was really bothering her now, by causing neck pain, and that she wanted to have the device removed. She indicated that her physician also wanted her to get her device removed. No further relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
Follow up with the physician's office found that the patient hadn't had her device checked in awhile but the patient thought it was completely dead. Therefore, the physician's office indicated that the pain was due to presence of the device. They indicated that they did not refer the patient for surgery. The manufacturer's battery life calculator was unable to verify battery depletion. No known surgical intervention has 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=6586095
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dennis100
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« Reply #582 on: May 18, 2019, 01:04:47 AM »

Model Number 302-20
Device Problem High impedance
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
Follow-up from the provider indicated the cause of the pain in the tooth could not be determined at the time, but was seen by the neurosurgeon. Review of the manufacturing records identified the generator met specifications prior to release.
 
Event Description
Lead revision surgery occurred. The explanted device was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604673
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dennis100
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« Reply #583 on: May 18, 2019, 01:05:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2016
Event Type  Injury   
Event Description
It was reported that the patient has been experiencing discomfort in throat with stimulation, dysphagia (not necessarily associated with stimulation), and pain on the roof of the mouth (not with stimulation) since the patient had the generator replaced. Patient's device was disabled due to these events a few months ago. Most events went away but the patient still experienced pain on the roof of the mouth. Patient did not experience these events prior to generator replacement. Patient had done well previously but is not seeing as much benefit with the auto stimulation as they would have liked. Patient would like to have the device explanted because of these events. No known explant surgery has not occurred to date.
 
Event Description
Patient's entire vns system was removed. The hospital was reported to discard all explants. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6568156
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dennis100
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« Reply #584 on: May 20, 2019, 09:42:09 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the migration and subsequent discomfort have been determined as not related to vns therapy but rather the physical presence of the device.
 
Event Description
It was reported that when the patient was seen in the physician's office a high impedance message was observed. This has been reported in mfg report # 1644487-2017-03741. It was also stated that the generator had migrated to under the patient's arm which was causing discomfort. The patient was referred for replacement due to all of these events. The generator and lead were replaced and discarded of. No additional relevant information has been received to date.
 
Event Description
Information was received from the surgeon that non-resorbable sutures were used during the implant of the generator indicating that was not this cause of the migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6554051
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dennis100
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« Reply #585 on: May 20, 2019, 09:42:52 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient requested to have her vns system explanted because she was having pain at her generator and electrode sites. The patient had explant surgery. The explanted products have not been received to date.
 
Event Description
The explanted generator and lead were discarded by the hospital. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6556278
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dennis100
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« Reply #586 on: May 23, 2019, 11:27:46 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/02/2017
Event Type  Injury   
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 was seen by his primary care physician due to concerns of a possible infection. The primary care physician noted that the patient had keloid formation, purulence, pain, warmth, and erythema all present in the chest area or at the generator incision site. The physician believed that the infection was caused by the patient's severe case of chest acne, which was incredibly active around the generator incision site. The combination of the bacteria from the acne and the incision site led to the possible infection, according to the physician. The patient was later referred to his implanting surgeon for follow-up. The patient was seen by his implanting surgeon. The patient reportedly had an abscess at his generator incision site, according to the surgeon. Cultures were taken and confirmed the presence of the infection. The patient was told to continue taking his antibiotic medication, which appeared to be related to his acne. The patient was seen one week later by the surgeon, and the infection at the incision site began to heal. No additional intervention was taken for the patient's infection. The device history records for the lead and generator confirmed that the devices met all sterilization specifications prior to distribution. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6672229
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dennis100
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« Reply #587 on: May 23, 2019, 11:28:22 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2017
Event Type  Injury   
Event Description
It was reported that the patient's vns was bothering her in her neck and shoulder. The physician referred the patient for generator replacement surgery due to the pain and for better seizure control. It was later reported that the patient's vns generator was completely depleted, which indicated that the issue that the patient was experiencing in the neck and shoulder were most likely not related to stimulation. Attempts for further information were unsuccessful to date. No known surgical intervention has occurred to date.
 
Event Description
The patient's mother reported that the patient also felt an electrical shock throughout her body when the device went off, and the physician told her that this was normal. The patient also reportedly experienced lead protrusion and discomfort. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6682630
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dennis100
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« Reply #588 on: May 23, 2019, 11:28:57 PM »

Model Number 102
Event Date 07/30/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809
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dennis100
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« Reply #589 on: May 27, 2019, 11:22:37 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/15/2003
Event Type  Injury   
Event Description
It was reported that the patient was diagnosed with left vocal cord paralysis. Further follow-up found that the patient had been experiencing pain in her throat for several months before being evaluated by an ent who diagnosed the patient with left vocal cord paralysis. It was determined by the physician that the vocal cord paralysis was related to the initial lead implant surgery which had occurred several years earlier. Manufacturing records for the lead were reviewed, and the device conformed to specifications prior to release. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6648317
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dennis100
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« Reply #590 on: May 27, 2019, 11:23:23 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/10/2017
Event Type  Injury   
Event Description
A patient reported that he had been experiencing pressure in the back of his head since his vns was initially implanted. The patient stated that the pressure was constant and did not occur with stimulation. The patient's device was programmed off for one week, but that did not relieve the pressure, nor did pain medication. The patient was later hospitalized for two weeks due to the pressure and a bout of non-epileptic seizures. The patient's treating neurologist reported that the patient had previously complained of this head pressure at his previous appointment prior to the report. The patient's vns output currents had been programmed down in response at that appointment. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The surgeon's office reported that the patient was referred for surgery to have the anchor tether of his lead removed due to it poking him. A company representative believed that the surgery had already occurred, but the surgical intervention has not been confirmed to date. No additional relevant information has been received to date.
 
Event Description
The anchor tether removal surgery was performed as intervention for the patient's pain and dysphagia. The surgery was for patient comfort and was not required to preclude a serious injury. Per the surgeon, the dysphagia improved some after surgery, and the pain fully resolved after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6649218
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dennis100
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« Reply #591 on: May 27, 2019, 11:24:03 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
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« Reply #592 on: May 30, 2019, 06:29:52 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported that the patient's generator was explanted due to complications in 2010. The reason was indicated as neck discomfort associated with the vns. The manufacturer's battery life calculator indicated that the patient was likely not receiving stimulation due to normal battery depletion. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6615451
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« Reply #593 on: June 01, 2019, 03:52:00 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/22/2017
Event Type  Injury   
Event Description
It was reported to a company representative that a patient has requested to have her device removed due to pain at the generator site. She is diagnosed with mental health problems and the patient¿s physician believes the pain is mostly psychological. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the company representative who spoke to the provider indicated that the patient also had pain in the neck from when her grandson had slapped her on the neck. The device was turned off for a couple of weeks and was turned back on with no discomfort and the problem was considered resolved.
 
Event Description
Follow-up from the provider indicated that the neck pain had resolved and the most recent diagnostics were okay.
 
Event Description
Further follow-up from the provider indicated that trauma to the neck has partially dislodged, damaged the electrode and was causing pain. Lead revision surgery occurred, and the explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on follow-up report #3 that the device had been received by the manufacturer.
 
Event Description
The explanted device was received by the manufacturer. Documentation received indicated that the patient felt a lead pulling sensation and then painful stimulation. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Event description, corrected data: the results of product analysis for the returned generator were inadvertently not provided in follow-up report #4.
 
Event Description
Analysis was completed for the returned lead. The electrode array portion was not returned for analysis, and evaluation could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727567
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dennis100
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« Reply #594 on: June 01, 2019, 03:52:38 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2017
Event Type  Injury   
Event Description
A nurse reported that a patient began experiencing bruising on his left hand, difficulty moving his left arm, jerking in his left arm, and some pain. The patient's symptoms had reportedly begun after the patient's device had been programmed up to a certain level. X-rays were reviewed for the patient having these issues by a company representative and it was found that the patient's electrodes had been inverted during placement. No other anomalies were identified in the x-ray images. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724226
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« Reply #595 on: June 01, 2019, 03:53:20 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
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 felt his generator move and then experienced a ¿shooting¿ pain. It was believed the pain was related to the device position. The patient¿s generator stated to have moved higher and toward the shoulder about a year prior due to significant weight loss. The patient was lying on his side that was causing soreness. The patient was prescribed pain medication, and the patient¿s surgeon decided to move the device lower in the patient¿s chest to try to alleviate the pain. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6730942
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dennis100
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« Reply #596 on: June 02, 2019, 07:14:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2008
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? no; 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 underwent explant of the lead and generator without a replacement. Explant surgery was due generator migration that caused discomfort. The generator and lead were received. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695395
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dennis100
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« Reply #597 on: June 02, 2019, 07:15:52 AM »

Event Date 06/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's vns battery had depleted quickly from approximately 80% to 25 or 30%, though, no timeframe was provided. It was also reported that the patient felt pain around the electrodes, which was resolved when the patient taped the magnet over her generator. The patient also felt constant pain around her generator and tenderness. The physician observed no swelling or redness. There was no trauma to the area nor migration of the generator. The patient also stated that she felt as if the device was constantly going off. However, the autostim was reported as being disabled. Diagnostics were reported to be within normal limits. The doctor was considering x-rays to determine if there was a intermittent problem that wasn't detected with diagnostics. X-rays have not been reviewed by the manufacturer to date. A review of device history records was performed and revealed that the generator passed quality control inspection prior to distribution. The tablet data for the generator was received and reviewed by the manufacturer. Only data from the day of the report was received and showed that the battery voltage was in the 25% range. However, based on the percent value of the battery capacity used, the battery voltage is lower than expected. An internal investigation was completed on premature battery depletion events. The results of the investigation observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths. This finding is indicative that the generator will reach true end of service earlier than expected. A secondary cause for premature 25% battery life indicators in a small subset of associated generators may be high beginning of life (bol) battery impedance. Generators only affected by this secondary root cause would be expected to rebound back to normal battery life levels without substantial programming changes. Revision surgery was scheduled for the patient due to the low battery status and it was reported that the physician believed the pain to be associated with the low battery. However, no surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: initial report inadvertently had selected adverse event. However, these events are being reported in mfg. Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report. Outcomes attributed to adverse event, corrected data: initial report inadvertently had selected required intervention to prevent permanent impairment/damage. However, these events are being reported in mfg. Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report. Describe event or problem, corrected data: initial report inadvertently reported pain around the generator, undesired stimulation, and painful stimulation in the neck. However, these events are being reported in mfg. Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report. (b)(4). However, these events are being reported in mfg. Report # 1644487-2017-04265 as they are unrelated to the battery depletion captured in this report.
 
Event Description
It was reported that the patient was being referred for full vns revision surgery as the patient had been having headaches in addition to the pain and stimulation related events which are captured in mfg. Report #1644487-2017-04265. These events, which were previously reported in this mfg. Report, #1644487-2017-04099, are now captured in mfg. Report, #1644487-2017-04265 as they are unrelated to the battery depletion captured in this mfg. Report. It was reported that the battery indicator was showing 25%. The patient's vns was programmed off. The full vns revision surgery was completed. The explanted generator and lead have not been received by the manufacturer to date.
 
Event Description
It was reported that the explanted devices had been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6691096
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dennis100
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« Reply #598 on: June 02, 2019, 07:16:59 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2014
Event Type  Injury   
Event Description
A patient began experiencing intermittent pain at the neck site in the neck in 2014. The patient has since reported in 2017 pain in her neck and in her chest and armpit area too, and wants the battery explanted. Clinic notes for surgical referral provided that the patient is requesting vns to be removed as she is having pain at the site of vns implantation up into her neck. The device has been off since 2015 she states she is unable to move her left arm above her chin level. The notes provided they were unable to palpate chest wall to check for vns placement due to pain as the patient moves away and refuses further examination. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
The generator was later explanted, but has not been received by the manufacturer to-date.
 
Event Description
The explanted device was reported to have been discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695815
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dennis100
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« Reply #599 on: June 02, 2019, 07:17:51 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2016
Event Type  Injury   
Event Description
It was reported that the patient started experiencing a pulling sensation on her lead that was causing pain. The patient saw a surgeon, and the physician agreed to explant the device. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6693872
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