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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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