Pages: [1] 2 3 ... 10
 1 
 on: Today at 11:26:10 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problems Generator; Vibration
Event Date 10/05/2015
Event Type  Injury   
Event Description
It was reported the patient is experiencing constant vibration at her generator site and alleges the vns has stopped controlling her seizures. It was noted the patient had a new implant on (b)(6) 2014 and was relatively well controlled prior to reporting the vibration and lack of efficacy. It was later reported the patient self-referred herself to the surgeon but the patient did not see her neurologist. The patient was reporting vibration with her generator but the surgeon didn't find anything wrong. It was reported the patient is having an increased in seizures and the magnet doesn't work anymore like it used to. It is unknown if the increase in seizures is below, at, or above pre-vns levels. It was reported that diagnostics were run and everything was fine. The surgeon wanted to change out the patient's generator. Surgery is expected; however, no surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had her generator replaced on (b)(6) 2015 as the device was unable to be interrogated due to battery depletion. Product analysis for the returned generator was completed on (b)(6) 2015. The battery life calculation estimate was made using the "as received" parameters which resulted in approximately 7 years remaining until near end of service (neos) = yes. During product analysis, the generator's output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. Magnet activations were performed during the output monitoring and the generator demonstrated the appropriate magnet output for the programmed settings. Diagnostics were performed and the results were as expected for the programmed parameters. Additionally, an electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additional information was received which showed the surgeon's serial cable was the cause of the reported failure to program, not a depleted generator battery. The failure of the surgeon's serial cable has been captured in mfr. Report # 16444487-2015-06478. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225237

 2 
 on: Today at 11:23:48 AM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2015
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing pain around the generator site. Vns output current was decreased from 1. 25 ma to 1. 00 ma to make it more comfortable. Diagnostics were within normal limits and x-rays were reported as unremarkable. No known trauma to the generator site was suspected. X-rays were received and reviewed. The generator placement appeared normal in the left upper chest area and the feedthru wires appear to be intact. The lead pin does not appear to be inserted completely past the connector block but due to the angle of the pulse generator and the image quality, it cannot be conclusively assessed. Based on the images received, the source of the reported pain could not be determined. Clinic notes from an office visit on (b)(6) 2015 were later received indicating that the patient's vns was interrogated with patient in several different positions. Impedance ranged from 3050 to 3089 ohms. It was reported that the lead impedances have slowly increased over several months. Impedance was 2847 ohms in (b)(6) 2015, 2961 ohms in (b)(6) 2015, and 3089 ohms on (b)(6) 2015. Patient stated she has intermittent pain at the generator site which hurts randomly and with position changes. The pain does not only occur when device is stimulating. Patient was referred to surgeon to evaluate the vns site. Additional relevant information has not been received to date.
 
Event Description
Patient underwent generator and lead replacement on (b)(6) 2015. High impedance was observed prior to surgery during diagnostic testing but no obvious lead fracture was observed. It was reported that the patient had an excessive scar tissue surrounding the electrodes. Product return is expected but has not been received to date.
 
Event Description
Generator and lead were received for analysis on 12/01/2015. The reported fracture of lead and high impedance allegations were not verified within the returned lead portion. A portion of the lead (including the electrode array) was not returned for analysis; therefore an evaluation of the missing portion of lead cannot be made. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The reported allegation of ¿high impedance¿ was not verified during the generator analysis. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Additional information was received that the patient was in clinic for a follow up visit on (b)(6) 2015 after the full revision surgery. The patient is still experiencing pain associated with stimulation. The patient reports that when the device is programmed off, the pain subsides. Diagnostics were performed and the impedance was within normal limits (2624ohms). When the wand was placed over the generator in order to run diagnostics and the patient stated that that it was painful. The patient is on rapid cycling and no programming changes were performed. When diagnostics were performed, the patient had no reaction or discomfort. The patient requested that the device be programmed off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5206887

 3 
 on: Today at 11:20:34 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Material Protrusion / Extrusion
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient's lead is protruding from the neck during stimulation. The patient is having painful stimulation around where the generator is located, which "stings and burns. " there were no issues following the implant per the mother and the issues were believed to have started in (b)(6). Additional information was received that the patient continues to have seizures 10 to 30 minutes long despite vns and other medications. Patient's caregiver was educated about magnet use but the patient could use the magnet himself. During 1 previous er visit, patient's shoulder/collar bone muscle was reported to have been torn at the location where vns was placed. Patient did not have any injuries or falls that could have caused this. It is unknown if this is related to the presence of device or surgery. Patient was however reported to be manipulating the device. As patient is autistic, patient often flips the generator repeatedly and this causes the lead to be pulled at the nerve. Patient's vns was adjusted a few times for reaching patient's therapy level but is still at a low dose. Follow-up with the patient's mother showed that the vns also made it difficult for the patient to breathe sometimes, but the patient's pulse ox was normal. Attempts for additional relevant information were unsuccessful.
 
Event Description
Additional information was received that the patient did not show three times to the neurologist's office. During patient's next visit, the parent insisted on changing physician. Other than the device settings from (b)(6) 2015, no other relevant information was obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224983

 4 
 on: Today at 11:18:48 AM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Follow-up revealed that the painful stimulation was occurring in the left neck.
 
Event Description
Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5208395

 5 
 on: Today at 11:16:15 AM 
Started by dennis100 - Last post by dennis100
Model Number 101
Event Date 07/18/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death was not provided. The relationship of the cause of death to vns is unknown. No additional relevant information has been received to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was likely buried with the patient; therefore, no analysis can be performed. A copy of the death certificate was receiving indicating that the cause of death was ¿sepsis due to pneumonia, bacterial with aspiration. ¿ "the approximate interval between onset and death was 4 days. No autopsy was performed and the manner of death was listed as natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4010156

 6 
 on: Today at 11:13:10 AM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Event Date 03/30/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient stomach was twitching which was suspected to a suspected lead fracture. The patient's device was subsequently disabled. However, the patient's device was tested and showed lead impedance within normal limits (impedance value - 2500 ohms). Additionally, x-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received stating that the patient's device had been programmed back on to evaluate stimulation on-times by evoked potential monitoring. The recording were provided to the manufacturer for review. Based on the recordings, the patient's lead was suspected to be fractured as it appeared device stimulation was not being delivered. The patient's device was again disabled. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225087

 7 
 on: Today at 11:11:41 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problems Generator; Vibration
Event Date 10/05/2015
Event Type  Injury   
Event Description
It was reported the patient is experiencing constant vibration at her generator site and alleges the vns has stopped controlling her seizures. It was noted the patient had a new implant on (b)(6) 2014 and was relatively well controlled prior to reporting the vibration and lack of efficacy. It was later reported the patient self-referred herself to the surgeon but the patient did not see her neurologist. The patient was reporting vibration with her generator but the surgeon didn't find anything wrong. It was reported the patient is having an increased in seizures and the magnet doesn't work anymore like it used to. It is unknown if the increase in seizures is below, at, or above pre-vns levels. It was reported that diagnostics were run and everything was fine. The surgeon wanted to change out the patient's generator. Surgery is expected; however, no surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had her generator replaced on (b)(6) 2015 as the device was unable to be interrogated due to battery depletion. Product analysis for the returned generator was completed on (b)(6) 2015. The battery life calculation estimate was made using the "as received" parameters which resulted in approximately 7 years remaining until near end of service (neos) = yes. During product analysis, the generator's output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. Magnet activations were performed during the output monitoring and the generator demonstrated the appropriate magnet output for the programmed settings. Diagnostics were performed and the results were as expected for the programmed parameters. Additionally, an electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additional information was received which showed the surgeon's serial cable was the cause of the reported failure to program, not a depleted generator battery. The failure of the surgeon's serial cable has been captured in mfr. Report # 16444487-2015-06478. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225237

 8 
 on: Today at 11:10:12 AM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Follow-up revealed that the painful stimulation was occurring in the left neck.
 
Event Description
Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5208395

 9 
 on: Today at 11:08:52 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Insufficient Information
Event Date 10/01/2014
Event Type  Injury   
Event Description
It was reported on (b)(4) 2015 that during an appointment, intermittent pain with device stimulation was reported. At the appointment that the patient was having painful and continuous stimulation that has been keeping him awake for several weeks. The pain was said to have started about 3 months after implant. The patient's pulse with was reduced to 250us, which did not resolve the issue, but instead seemed to make it worse, so the physician decided to temporarily disable the device to see if this was the result of chronic irritation. When turned off the patient immediately started feeling better. No further relevant information has been obtained to date.
 
Manufacturer Narrative
Describe event or problem, corrected data, initial mdr inadvertently reported that the medical intervention was to preclude a serious injury.
 
Event Description
The initial mdr should not have been submitted as there was not indication that the medical intervention (device disablement) was to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225716

 10 
 on: Today at 11:06:57 AM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problems Extrusion; Lead
Event Date 10/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had inflammation and lead extrusion at the neck incision about six weeks after implant surgery. There was no indication of an infection. The physician did not know the cause of the inflammation or lead extrusion since the wound had been healing well after the implant surgery. On (b)(6) 2015, the lead was reinserted into the neck without the nerve and electrodes being touched during the procedure, and the incision was closed. The incision was reported to be healing well after the surgery.
 
Event Description
It was reported that an infection was present at the generator and lead sites on (b)(6) 2015. Infected skin necrosis on the left chest wall was found, and an open wound was visible with drainage. The generator and lead were explanted on (b)(6) 2015. The infection appeared spontaneously and was not attributed to patient manipulation. The physician plans to re-implant the patient with a new vns system in 3 months, because the patient responded well to therapy. The device history records for the generator and lead were reviewed, and both were sterilized prior to distribution. Attempts for additional information were unsuccessful to date.
 
Event Description
The physician believed that the cause of the infection was that the patient developed a seroma at the generator site 4 weeks post-op. Cultures were taken, and the result was staphylococcus aureus with multiple sensitivities (not (b)(6)).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224608

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