Pages: 1 ... 24 25 [26]   Go Down
Print
Author Topic: Chest Pain  (Read 246040 times)
0 Members and 3 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #750 on: May 11, 2019, 03:50:44 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #751 on: May 11, 2019, 03:51:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
It was reported that a patient was set to have a generator replacement for an unknown reason. One good faith attempt has been made to gather the reason for replacement and the surgeon reported that the replacement was due to chest pain at the generator site. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8529751
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #752 on: May 18, 2019, 01:29:39 AM »

Model Number 102
Event Date 09/08/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was hospitalized for evaluation of vns generator migration and painful stimulation that was occurring in the pt's left arm and chest at the generator site. The vns was to be disabled. The pt has had no trauma and does not manipulate the vns. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869526
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #753 on: May 23, 2019, 11:40:41 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #754 on: May 23, 2019, 11:41:29 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury   
Event Description
Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.
 
Event Description
Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551029
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #755 on: June 02, 2019, 07:44:09 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an episode where he experienced choking, and puking which he explained as a sensation that the generator was continually in magnet mode. He also reported a tingling sensation in his left arm associated with stimulation. X-ray images were reviewed and repealed no relevant information regarding the events. Additional clinic notes were received indicating that the patient reported that he experienced choking and shortness of breath sometimes. He felt scared during sleep. Patient complained of choking, shortness of breath, neck pain radiating left upper extremity. It occurred once in 10-15 minutes. In addition, he complained of pain in left chest and one episode of numbness in the left arm. The normal output current was disabled and magnet mode was left on. The physician notes that there was no abnormality on x-ray. The physician tried lowering the output current and adjusting the frequency, pulse width and duty cycle but the patient could not tolerate. Therefore the normal output current was disabled while leaving the magnet output current on. Patient has no symptoms when the device is disabled. No other contributory or casual events that preceded the reported events. The neurologist plans to refer patient to neurosurgery for a consult in regards to the electrode placement on the nerve. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695583
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #756 on: June 02, 2019, 12:25:25 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury   
Event Description
A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope. The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns. Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down. Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times. According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias. The patient's resting heart rate was reportedly 54 beats per minute. Device diagnostics were performed and returned results within the normal limits. Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years. The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns. No further relevant information has been provided to date.
 
Event Description
Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin. The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits. The chest pain radiated to the patient's left arm and shoulder. The patient was noted to be bradycardic. X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day. Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits. The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia. The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers. The patient's medications were adjusted several times during the hospital stay. The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685193
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #757 on: June 05, 2019, 01:39:26 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
An implant card was received indicating that the patient underwent generator replacement due to pain in chest. The lead impedance was marked as ok. Attempt to obtain additional information have been unsuccessful to date. It is unknown if the generator will be returned for analysis as the generator has not been received to date.
 
Event Description
On (b)(4) 2013, it was reported that if the generator had not been returned, it was likely discarded. Attempts for additional information have been unsuccessful as the physician reported the information was confidential.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3317147
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #758 on: June 07, 2019, 05:52:17 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Event Description
It was reported by the patient that she has continuous pain in her chest and shoulder, and wanted a smaller generator. The patient was referred for replacement. The patient was replaced due to battery depletion. The generator has not been received by livanova to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8574255
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #759 on: June 07, 2019, 05:52:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced sharp pains in their chest and neck with stimulation which began after a face forward fall. It was additionally reported by the representative that the patient experienced heart rate issues. Internal data of the patient's generator was reviewed and there was no evidence of any malfunction or anomalies with the generator. No further relevant intervention has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8597935
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #760 on: June 07, 2019, 05:53:26 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/08/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for explant as the device was unable to be interrogated and the patient was having pain in the left side of their chest at the generator site. The patient was not getting a replacement as they were doing well on their current medications. Programming history was reviewed for the patient and no anomalies were seen. An automatic battery life calculation for the patient found that there was 0. 0 years until near end of service. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8583709
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #761 on: June 08, 2019, 07:12:53 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
Clinic notes were received referring patient for generator replacement. The clinic notes indicated that the patient's seizure control was "pretty good" up until last year. The clinic notes indicate that the patient reported an aching pain in her left chest, near the vns. The patient also reportedly had a hoarse "grovelly" voice. 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=8626047
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #762 on: June 08, 2019, 07:13:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns 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=8621049
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #763 on: June 09, 2019, 02:02:32 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/15/2010
Event Type  Injury   
Event Description
It was reported that a vns patient was having trouble with their device and wanted it removed. The patient reports that the device was causing discomfort and pain from stimulation and presence of the device in both neck and chest area. Further follow up with the patient's nurse practitioner confirmed that the generator was turned off prior to (b)(6) 2018. It was confirmed that the patient has been referred to surgery, both for patient comfort reasons and to preclude serious injury. 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=8638725
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #764 on: June 10, 2019, 01:17:52 AM »

Model Number 105
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient underwent vns generator explantation surgery as it was noted that the patient had a non-functioning device. The patient's lead was reported as still implanted. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
Follow up with the physician's office revealed that the vns was functioning. However, the patient was complaining of pain to the left chest area and the vns generator had migrated down into the left breast.
 
Event Description
Follow up with the physician's office revealed that there was no known trauma or patient manipulation that could have contributed to the pain or migration. It was reported that the surgical intervention was for the patient's comfort.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6975426
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #765 on: June 19, 2019, 04:33:58 AM »

Model Number 304-20
Device Problems Fracture; Insufficient Information
Event Date 09/07/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received through a physician clinic notes that upon interrogation, an error was identified. The normal mode output current was turned off as a result. However, diagnostics were noted to be normal. Further information was received through clinic notes from the next appointment. The vns was reportedly interrogated and was found to be near end of service. Diagnostics were said to be abnormal because battery was near end of service. There were no changes made to the patient vns. A review of the device history record indicated the generator had passed all electrical tests and quality inspections prior to being released for distribution. No further relevant information has been received to date.
 
Event Description
Further information was received that x-rays were received by the manufacturer. These x-rays were later reviewed. Only a/p and lateral neck x-ray images were provided so the generator could not be evaluated in any of the images. Therefore, as assessment on the location of the generator, the insertion of the connector pins, and the integrity of the filter feedthru wires could not be made. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. As the lead is fed through the patient¿s left chest, it is positioned into a strain relief loop. The loop appears to be done per labeling. There does not appear to be a strain relief bend present. Three tie downs are present, all securing different areas of the loop. Since the generator could not be seen, it could not be determined whether the lead was routed behind the generator and if the lead wires were intact at the connector pins. No sharp angles or gross discontinuities were identified in the visible portion of the lead. No additional relevant information has been received to date.
 
Event Description
Further information was received that high impedance was observed on the patient's vns. The patient also reported having pain at the generator site. It was later discovered that high impedance was first observed in september. The error message noted in the original clinic notes was reportedly in reference to the high impedance message seen although the notes from that day indicated normal diagnostics. A review of the device history record of the lead indicated it had passed all quality inspections prior to being released for distribution. No surgical intervention has occurred to date and no additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7102368
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #766 on: June 19, 2019, 04:34:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
Report received that a patient had pain at the generator incision site. The physician later indicated that he believed the generator was positioned too laterally. However, there was no indication that it had migrated from its original position. Further information was received that the patient presented with episodes of pain which reportedly spread to the left neck. He also had coughing. Both of these events reportedly occurred with stimulation. The physician indicated that he believed this was indicative of a malfunction of the generator. The patient was referred for surgery, although it was not stated whether it was a planned pocket revision or full vns revision. The vns was turned off. The physician's notes indicated that a "lead test" was performed and results were ok. However, impedance value was not noted. No further relevant information has been received to date.
 
Event Description
Further information was received that the patient experienced both painful stimulation that occurred "several times a day" and pain in the chest. The physician reportedly did not know whether the generator had migrated. The physician did not know the cause of the pain and painful stimulation and if the two events were related to the possible migration. The impedance value from the clinic visit where the patient first reported the adverse events was provided. It was within normal limits. Further information was received that the patient was seen by the surgeon. The surgeon determined that a revision was not necessary because the main source of the patient's pain was from the stimulation. This was able to be controlled by decreasing the vns pulse width. The surgeon did confirm that the device may have migrated outside of the pocket, but remained in a good place and was not a contributing factor to the painful stimulation. Information from the implanting surgeon indicated that non-absorbable sutures were not used to secure the generator in the pocket at the last replacement. No further relevant information has been received to date. No further relevant intervention has been taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7102536
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #767 on: June 28, 2019, 11:33:31 PM »

Model Number 105
Event Date 01/15/2015
Event Type  Injury   
Event Description
It was reported that a recently implanted patient is having a hard time tolerating stimulation at around 0. 25mv - 0. 5ma. The patient experiences tightness in the chest, throat pain, and voice alteration and tachycardia associated with vns stimulation. Additional clinic notes were received for the patient. Clinic notes indicate that the patient was able to stop 3 seizures by swiping the magnet. When vns settings were increased from 0. 5 ma to 0. 75 ma, on (b)(6) 2015 the patient experienced mild palpitations and hoarseness of the voice with the increase but was reported to be able to tolerate it at the current level. Due to patient's concerns regarding discomfort with stimulation routinely (voice hoarseness, palpitations (tachycardia), chest discomfort and throat pain), the physician made a decision to decrease settings back to previous settings on (b)(6) 2015. Additional system diagnostic results was received. It was also reported that the patient continues to experience dysphagia when vns output current is increased to 0. 5 ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4583522
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #768 on: July 06, 2019, 12:05:01 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported in (b)(6) 2018 that the patient was being referred for explant due to pain and swelling. In (b)(6) 2018, it was reported that the patient first reported chest pain about a year prior. It was mentioned that the patient wanted to have their device explanted because they felt that the device was not helping, however the device was disabled earlier that year as the physician stated there had been reduction in the frequency of seizures. In (b)(6) 2018, the surgeon believed that it was highly unlikely that the vns device was causing the pain and swelling, and the neurologist believed that the pain was due to possible fibromyalgia, unrelated to the vns therapy system. The surgeon went on to state that he informed the patient that explanting the generator would not guarantee pain reduction or pain alleviation. However, due to the patient being adamant about explanation, the patient was referred for surgery. Device diagnostics information was not received at this time, however it was mentioned that the patient was at a low setting. The patient later reported, in (b)(6) 2019, that the vns caused jerking, falling, strokes, flushing of the breasts (turned red per patient), and pain throughout the body. The patient also mentioned that the vns caused both their breasts to hurt and turn red, and that both breasts needed to be taken out. Multiple attempts have been made to the physician for an assessment of these allegations, and there relationship to the vns and surgery referral, however no response has been received to date. 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=8724571
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #769 on: July 06, 2019, 12:05:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced constant pain in their chest and believed it was contributing to a loss of function in the left side of their body. The patient's physician indicated that the pain could be related to presence of the device or a muscle tear around the generator site. The physician reported that there was "no medical explanations for the pain, the incision site is normal and impedance is within normal limits. " the physician believed the pain to be related to a musculoskeletal injury. The patient reported that the pain at the generator site and neck was disrupting her quality of life, disrupting her sleep and work. The patient was referred for generator explant. 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=8685279
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #770 on: July 06, 2019, 12:06:24 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/07/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's neurologist reported that the patient's seizures had worsened and the patient experienced chest tightness / pain. It was reported that the vns stimulation was the cause of the adverse events and that there were no known external factors contributing to the patient's reported adverse events. It was reported that the patient was unable to tolerate the vns stimulation which led to the device output currents being disabled. 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=8695977
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #771 on: July 11, 2019, 02:30:47 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/15/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's vns generator and leads were explanted due to discomfort at their anterior chest. The suspect product was received by the manufacturer for product analysis. Product analysis has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8695456
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #772 on: July 14, 2019, 04:49:06 AM »

Model Number 103
Event Date 01/05/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns pt is scheduled for a full revision surgery in (b)(6) 2011. The pt have been experiencing pain to her neck upon stimulation since her battery replacement surgery in (b)(6) 2011. The pt has about 1. 3 years left of battery life and a lead impedance value of 2278 ohms. The pt also said that she was experiencing pain in both arms since the battery replacement surgery in (b)(6) 2011. The physician reported that the pt is at high settings but that diagnostic results are within normal limits. No change in medication or settings and no trauma or manipulation to the device occurred. Clinic notes from the physician were rec'd review of clinic notes dates (b)(6) 2011 report that the pt is complaining of pain in the chest and left arm due to vns. The clinic notes also state that the pt is having more seizures and that the vns magnet is not kicking in. The clinic notes reveal that the pt was being referred to a vns implanting surgeon for a second opinion regarding the vns causing chest and left arm pain. Additional information regarding the pt's pain and seizures has been requested from the pt's physician; however, no further information has been rec'd to date. When additional information is rec'd, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133616
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #773 on: August 10, 2019, 03:16:12 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2019
Event Type  Injury   
Event Description
A report was received that a patient has chest pain, increased heart rate, and coughing when the patient is around any metal - notably spoons and the patient's magnet. The patient stated that the neurologist lowered their settings to as low as they can go and the patient is still experiencing these events. Further follow up with the physician's office revealed that the patient has not yet been seen by the physician, but that the patient's nurse believes the patient might just not be able to tolerate her current settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764840
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #774 on: August 10, 2019, 03:17:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was referred for generator replacement. Within the clinic notes, information was received that the patient experiences pain related to stimulation in their left neck, chest, and shoulder, as well as pain when their lead is palpated. Additionally, the notes mentioned that the patient suffers from left vocal cord paralysis. The clinic notes detail that the patient experienced shingles, not alleged due to the vns, and that the patient believes the shingles "messed up her device" since the reported pain did not occur until after the patient experienced shingles. Within the clinic notes the surgeon informed that the patient's symptoms and the device are not likely associated, but that the device did need to be assess to ensure that it was not causing other symptoms. It was reported in clinic notes that the device was previously checked, and that the impedance was within normal limits and the physician made no changes to the patient's settings. Additional information was received that the physician indicated that the patient's referral for replacement was due to pain. The neurologist's office indicated that the device removal due to pain is for patient comfort reasons. However, no additional information was received in regards to the vocal cord paralysis, and its relationship to the surgery referral and pain. 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=8754630
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #775 on: August 10, 2019, 03:17:45 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/13/2019
Event Type  Malfunction   
Event Description
A report was received that a patient's device has high impedance. Further information was received that the patient originally had high impedance and now has impedance within normal limits. X-rays were performed and the neurologist reported that there were no anomalies seen. The patient is also experiencing pain across her chest. Diagnostics were attempted in different positions to check for a positional break however the impedance was within normal limits. Ap and lateral chest x-rays were received and reviewed and per the images received, the connector pin appears to be fully inserted inside the connector block. The placement of the generator is normal. The feed thru wires seem intact at pin site. The leads were located next to and just above the generator and the lead wires at the connector pins seem intact. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. A strain relief loop and bend were both present. The strain relief bend appears to be placed per labeling, with the lead placed parallel to the electrodes, except for the placement of the tie downs. Four tie-downs are also placed however not per labeling as the tie downs are not located parallel to the electrodes. No gross fractures or sharp angles were able to be visualized in the images provided. Based on the x-rays received, the cause of the high impedance cannot be determined. Note that a microfracture cannot be ruled out based on the images provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8769401
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #776 on: August 10, 2019, 03:18:24 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/15/2019
Event Type  Injury   
Event Description
The physician's office reported that the patient was experiencing shortness of breath and pain/discomfort at the chest site. It was mentioned that after the vns device was turned off, the chest pain and shortness of breath resolved. The physician wanted the patient referred to the surgeon. Further follow up was performed with the physician; however, they refrained from providing additional information. 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=8808022
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #777 on: September 07, 2019, 02:43:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2019
Event Type  Injury   
Event Description
It was reported that a patient is requesting their device to be removed due to pain that she is attributing to the vns. The patient's device was turned off when pain was first experienced, also because the patient is seizure free. The patient was seen recently and is still reported pain even with the device programmed off. It was stated within clinic notes that the leads were not showing any increased resistance, meaning the impedance had shown to be within normal limits. The pain decreased mildly however the patient still reported daily pain, shooting pain to left neck and chest and is requesting her vns to be removed. 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=8912133
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #778 on: September 07, 2019, 02:44:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2019
Event Type  Malfunction   
Event Description
It was reported by the case manager that the patient reported having chest pain, seizures and magnet was not working. Attempts were made to obtain further information from the patient and who the following neurologist, however no response has been received to date. Since current neurologist is unknown, no further attempts for information can be made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8854951
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64231


« Reply #779 on: September 07, 2019, 02:45:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/08/2019
Event Type  Injury   
Event Description
The physician reported that a patient was having therapy related pain. There was no high lead impedance, and per the physician the patient's x-ray looked normal; however, the physician still believed that there may be something wrong with the generator. The sales representative visited the patient in the hospital to check the device. The sales representative reported that the system diagnostics were within normal limits. Clinic notes were later received confirming that the patient had been referred for generator/lead revision to upgrade to a m1000 sentiva generator. The clinic notes were reviewed and mentioned that the patient continues to have intermittent chest pains. The physician noted that the plan for the reported pain was to refer the patient to the surgeon for replacement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8855009
Logged
Pages: 1 ... 24 25 [26]   Go Up
Print
Jump to: