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dennis100
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« Reply #30 on: March 14, 2019, 06:07:05 AM »

Model Number 105
Device Problems Generator; Malposition of device
Event Date 09/04/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 clinic notes were received dated (b)(6) 2015 which indicate that the surgeon repositioned the patient's generator on (b)(6) 2015 and patient did well and went home and then on (b)(6) 2015 the patient felt it move lower in her chest. The surgeon noted that the incision looks good but that the generator is indeed lower in her chest than it was placed. The surgeon noted that he did tie the generator down last time to the fascia above her pectoralis muscle. Good faith attempts for further information from the physician have been made but no additional information has been received to date.
 
Event Description
The surgeon reported that a non-absorbable suture was used to secure the generator to the fascia during implant. The primary care physician told the surgeon that he believes the patient would intentionally manipulate her device.
 
Event Description
It was reported on (b)(6) 2015 that a generator revision surgery occurred on (b)(6) 2015. The patient's generator was repositioned to her back. The diagnostics following repositioning were reported to be within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5161451
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dennis100
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« Reply #31 on: March 18, 2019, 02:07:32 AM »

Model Number 304-20
Device Problems Low impedance; Component Missing ; Material Protrusion / Extrusion; Lead
Event Date 11/04/2015
Event Type  Malfunction   
Event Description
It was reported that a low impedance warning was received during diagnostic testing of a patient's generator. The patient had a bandage over his generator incision site. The patient underwent exploratory surgery to determine the cause of the low impedance. When the bandage was removed from the generator incision site, a portion of the lead was sticking out of the generator incision. Two surgeons spent 1. 5 hours searching for the rest of the lead, but they were unable to find it other than a small portion of one of the coils in the neck. There was an infection present at the generator site, so the surgeons decided to remove the generator and remaining portion of the lead that was attached to the generator. X-rays and ultrasound confirmed that no lead was present. The surgeons believed that the patient pulled the lead out of his body through the generator incision site. The device history record for the lead was reviewed, and the lead was sterilized prior to release. Attempts for further information regarding the infection were unsuccessful to date. The explanted generator and remaining portion of the lead have not been received to date. The patient has not had a new vns system implanted to date.
 
Event Description
Analysis was completed on the generator on 01/11/2016. The generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The explanted generator and remaining portion of lead were received on 12/14/2015. Analysis on the lead was completed on 01/05/2016. The portion of the lead containing the manufacturing id tag was not returned, thus the model and the serial number of the returned lead portion could not be verified. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an 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. Analysis has not been completed on the generator to date.
 
Event Description
The cause of the infection was the patient picking at the incision site until it opened up and exposed the lead. It has been planned to replace the vns system in the future with the generator implanted on the patient's back. The patient has not had re-implant surgery to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5252502
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dennis100
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« Reply #32 on: March 29, 2019, 08:08:59 AM »

Model Number 102R
Device Problem Therapeutic or Diagnostic Output Failure
Event Date 10/29/2015
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2015 noted that the patient complains of pain in her left arm, left leg and at time in the left side of her face for approximately 3 weeks. It was noted that the patient was unsure if the pain was coming from her vns. It was also noted that the patient noted there was a knot on her back where the generator is placed. The patient was referred to the surgeon to determine what the next step would be. It was later reported that the patient underwent generator replacement surgery. It was reported that the explanting facility does not return explanted devices for analysis; therefore, no product analysis can be performed. The surgeon indicated that the patient underwent generator replacement due to pain. The surgeon indicated that the pain was not associated with stimulation, but rather the presence of the device. Device diagnostics were within normal limits (dc dc -2). Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the patient determined that the pain was from a recent fall and was now feeling better. Generator replacement was done for patient comfort. The patient has not experienced any pain since generator replacement. Device diagnostics were within normal limits.
 
Manufacturer Narrative
Date of event; corrected data: this information was inadvertently reported incorrectly on the previous mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5417620
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dennis100
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« Reply #33 on: April 04, 2019, 01:20:39 AM »

Model Number 302-20
Event Date 05/23/2016
Event Type  Malfunction   
Event Description
It was reported by a physician that diagnostics for a patient showed low impedance. The physician stated the device still seems to be working and the patient is not having seizures. Follow-up by the company representative to the physician revealed there was no trauma or manipulation around the lead or generator. No adverse events have been experienced. There were no previously recorded issues with the device diagnostics. X-rays were planned to be taken, but have not been received by the manufacturer for review. Additional relevant information has not been received to-date.
 
Event Description
Follow-up by the company representative who attended the patient's follow-up visit revealed that the patient's generator is low in the back area below the ribcage which was requested due to cosmetic reasons. The patient reported it felt like it would "catch or feel funny, like it was caught on something". Two diagnostics at the time indicated high lead impedance. The output current was lowered to 1. 0 (from 1. 75ma the lead impedance upon diagnostics registered as high. Diagnostics performed after output current reduction to 0. 5ma resulted in high lead impedance. The patient was reprogrammed to 1. 0ma and was referred for revision surgery. No known surgery has occurred to-date.
 
Event Description
Revision surgery occurred on (b)(6) 2016. Prior to surgery, system diagnostics showed high impedance. An incision was made to remove the generator, the pin was removed and reinserted three times which showed high impedance each time. The test resistor was inserted and generator diagnostics were performed showing impedance values were within normal limits with the resistor in place. Lead revision was performed. The generator was not replaced. Lead impedance was tested out of the pocket and inside the pocket and was within normal limits. The lead was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5735989
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dennis100
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« Reply #34 on: April 06, 2019, 01:37:08 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
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dennis100
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« Reply #35 on: April 11, 2019, 02:36:37 AM »

Model Number 105
Event Date 07/04/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had a recent re-implant due to infection, previously reported in mfr. Report 1644487-2016-00690. The patient was re-implanted in the back but he had figured out how to rub his back on the carpet and now the second generator is extruding from the skin. The second vns was removed on (b)(6) 2016 and will likely not be replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5801765
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dennis100
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« Reply #36 on: May 03, 2019, 01:59:35 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/28/2017
Event Type  Death   
Event Description
It was reported that the patient died in seizure at a hospital. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
The patient's autopsy report indicated that the patient had went to the hospital complaining of lower back pain in the left lower back and urine retention, found to be caused by a kidney stone. This was treated with a foley catheter. After a day, patient had a seizure while he was eating. He had persistent aspiration after the seizure and was later pronounced dead. The patient's autopsy showed food aspiration in the tracheobronchial tree and in the alveoli with foci pneumonitis, the latter probably due to previous small aspirations. There were associated areas of pulmonary edema and parenchymal hemorrhages. Cause of death was determined to be due to respiratory failure secondary to food aspiration during a seizure attack. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434921
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dennis100
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« Reply #37 on: June 08, 2019, 06:16:28 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/09/2019
Event Type  Injury   
Event Description
Clinic notes received indicated that the patient felt electrical impulses in the back of her neck and the experience of bugs falling on her back. It was noted that the patient was worried that the vns was malfunctioning. The physician noted that the battery was at ifi (intensified follow-up indicator)=yes. The patient was referred for battery 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=8636343
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dennis100
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« Reply #38 on: June 11, 2019, 01:01:06 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported by the patient that he was unable to find a physician to address the issues he was having with the vns. The patient reported that he has had 52 outbreak seizures with the vns and a maximum dosage of keppra, though no timeline was provided. The patient reported severe pain in the chest, upper back, and middle back. The company representative followed up with the patient who was asking for physicians who could prescribe pain medication. The patient told the company representative that physicians would not see him and were sending him certified letters. It was reported that the patient was referred for vns replacement surgery. Follow up with the patient's last known treating neurologist revealed that they did not see the patient anymore and had not in a while. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent vns generator replacement surgery due to battery depletion. The explanted generator has not been received by the manufacturer to date.
 
Event Description
The explanted generator was received by the manufacturer and product analysis was completed. Proper functionality of the generator was successfully verified in the product analysis, or pa, lab. The septum was examined and was not cored, eliminating the possibility of unintended electrical current through body fluids. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No variation in the signal was observed and the generator provided the expected level of output current. Magnet activations demonstrated appropriate magnet output current. The generator performed according to functional specifications. Diagnostics were as expected during testing. There were no performance or other adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949980
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dennis100
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« Reply #39 on: June 14, 2019, 06:15:38 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/06/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
A report was received that a patient is having their device explanted because the lead is fractured and exposed through the skin. It was stated the vns was implanted on the back due to the patient picking at the device. It was reported that the physicians believe the patient picked out the current implanted leads. It was reported that the lead is completely fractured and will be returned to livanova. The patient's generator and lead have been explanted. The physician alleged the patient's lead extrusion and fracture of leads due to patient influence based on patient past history. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8659999
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