Pages: 1 [2] 3 4 ... 10
 11 
 on: May 23, 2019, 11:32:00 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/27/2016
Event Type  Injury   
Event Description
It was reported that the patient was experiencing discomfort with stimulation in her throat. This was not ameliorated with attempts to lower settings. The physician expressed wanting to get the patient¿s vns explanted. Lead impedance was within normal limits, and review of x-rays by the physician did not show any obvious problems that could be causing or contributing to the painful stimulation. X-ray images taken after the onset of the painful stimulation were reviewed by the manufacturer. Ap and lateral x-rays of the neck and an odontoid view were included in the reviewed images. The generator was placed normally per labeling. The connector pin of the lead could not be fully assessed to be inserted inside the connector block due to the viewing angle and quality of the image. The feedthru wires appeared intact. The electrode placement appeared to be per device labeling. A small portion of the lead was behind the generator, making the lead difficult to assess in this area. There were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. The wires at the lead connector pin appeared to be intact. No additional pertinent information has been received to date.
 
Event Description
Communication with the patient¿s treating physician showed that surgery was not to preclude a serious injury and was simply in relation to discomfort. Surgical intervention has not occurred to date, and no additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6548498

 12 
 on: May 23, 2019, 11:31:06 PM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2017
Event Type  Injury   
Event Description
A patient reported that while getting a head mri, the battery had not been turned off and she stated it got hot at the battery and at the attachment to the vagus nerve. The department was aware that she has a vns and was given her id (implant) card. The patient reported having passed out from pain. Follow-up by the company representative provided that the patient was last seen on (b)(6) 2017 and systems diagnostics were normal. The patient's generator was turned off. Additional relevant information has not been received to-date.
 
Event Description
X-ray images were received and reviewed. Based on the x-rays received, the cause for the painful stimulation could not be determined. There was no visual indication of damage to the generator or lead. However, the presence of an abrasion or a micro-fracture in the lead could not be ruled out.
 
Event Description
Follow-up from the physician has provided that the patient may have psych issues involved as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6676919

 13 
 on: May 23, 2019, 11:30:30 PM 
Started by dennis100 - Last post by dennis100
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

 14 
 on: May 23, 2019, 11:28:57 PM 
Started by dennis100 - Last post by dennis100
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

 15 
 on: May 23, 2019, 11:28:22 PM 
Started by dennis100 - Last post by dennis100
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

 16 
 on: May 23, 2019, 11:27:46 PM 
Started by dennis100 - Last post by dennis100
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

 17 
 on: May 23, 2019, 11:26:06 PM 
Started by dennis100 - Last post by dennis100
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

 18 
 on: May 23, 2019, 11:24:29 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/16/2015
Event Type  Injury   
Event Description
It was reported that a patient was experiencing painful stimulation. At the patient's request, the neurologist referred the patient to a surgeon for lead revision surgery; however, the functionality of the lead is unclear. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The neurologist reported that the patient's painful stimulation began around 1. 5 years prior to the report. The patient reportedly felt the pain in her neck and all the way up into her ear. The neurologist did not believe the painful stimulation was caused by a lead fracture. The lead revision surgery that was planned as intervention for the painful stimulation was for patient comfort at the time of referral. Diagnostic test results from the date that the painful stimulation began were within the normal limits. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546060

 19 
 on: May 23, 2019, 11:23:30 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest. The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes. However, the physician noted there was no migration of the device and was fine. The explant occurred for the patient comfort as she simply wanted it removed. It was also reported the patient believes the device was causing her psoriasis. Explant surgery occurred. The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.
 
Event Description
Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns. The provider states the vns was working for the patient. Analysis was completed for the returned generator. Functionality of the generator to provide the programmed output currents was successfully verified. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed for the lead. The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666114

 20 
 on: May 23, 2019, 11:22:01 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/16/2015
Event Type  Injury   
Event Description
It was reported that a patient was experiencing painful stimulation. At the patient's request, the neurologist referred the patient to a surgeon for lead revision surgery; however, the functionality of the lead is unclear. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The neurologist reported that the patient's painful stimulation began around 1. 5 years prior to the report. The patient reportedly felt the pain in her neck and all the way up into her ear. The neurologist did not believe the painful stimulation was caused by a lead fracture. The lead revision surgery that was planned as intervention for the painful stimulation was for patient comfort at the time of referral. Diagnostic test results from the date that the painful stimulation began were within the normal limits. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546060

Pages: 1 [2] 3 4 ... 10