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dennis100
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« Reply #120 on: January 05, 2019, 01:23:30 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Initial report was that a patient was referred for generator replacement due to desire for latest model. Further information was received on the day of replacement that high impedance was observed on the lead during the surgery. The lead appeared to be sutured down resulting in lead damage and the lead was reported to be opened when the surgeon was assessing the lead in surgery. During the surgeon's assessment of the lead, the lead ripped. Further information was received that a stitch had been used by the previous surgeon to secure the lead to tissue and that the lead was either pierced with a needle or that the stitch wore through the lead overtime resulting in the damage. It is stated that the lead's insulating coating cracked significantly resulting in the high impedance. The surgeon proceeded with lead replacement. The lead was returned and is pending product analysis completion. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8128889
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dennis100
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« Reply #121 on: January 05, 2019, 01:24:22 AM »

Model Number 105
Device Problems Crack; Detachment of Device or device Component
Event Date 12/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported during the investigation for high impedance on the patient's vns, which is reported in mfg. Report #1644487-2018-02288, that during the vns replacement surgery, the vns generator's header was found to be cracked and detaching from the generator can. Follow up revealed that the surgeon stated that it may have been the result of the vns surgery, but was not 100% sure. Therefore, it is unknown the role, if any, the damaged and detaching header played in the high impedance. It was stated that the surgeon had planned to replace the generator during the surgery anyways. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The return of the explanted product is not expected. No additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8162504
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dennis100
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« Reply #122 on: January 06, 2019, 03:38:04 AM »

Model Number MODEL 250
Event Date 01/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that a programming system was not working due to communication issues. The programming system would work intermittently and the communication difficulties were confirmed on a demo device. The 9v battery was not the cause of the communication issues. The programming system was returned to the manufacturer where the failure to program was confirmed and attributed to an intermittent conductor in the serial data cable. Once the cable was substituted, all communication errors cleared. No issues with the returned flashcard were noted. During analysis of the returned handheld, it was identified that some of the sync cable connector leads were damaged and that the solder connections between the sync cable connector leads and the pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. It was also identified that the serial cable was unable to establish communication using a known good wand and the returned handheld. The cause for the communication difficulties is associated with a broken wire connection on the axim connector plug pcb. Once the wire was soldered back onto the dell axim connector plug pcb, the serial cable was able to establish communication between the handheld and wand. The most likely cause for the wire breaks can be associated with mishandling of the serial cable. The communication errors associated with the intermittent conductor in the wand will be reported via alternate summary reporting.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632939
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dennis100
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« Reply #123 on: January 12, 2019, 02:14:45 AM »

Model Number MODEL 250
Event Date 03/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that nurse¿s handheld device was charging intermittently. The serial cable had to be in a certain position in order for the handheld to charge. The serial cable was swapped but the issue was not resolved. It was reported that no mishandling had occurred. The handheld device was returned to the manufacturer for analysis. Analysis of the returned handheld did not identify any anomalies associated with the main battery. Analysis of the handheld did identify that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736888
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dennis100
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« Reply #124 on: January 16, 2019, 01:09:29 AM »

Model Number MODEL 250
Event Date 04/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the nurse¿s handheld device had a faulty serial cable that required specific positioning to allow intermittent communication. An analysis was performed on the returned handheld and a likely cause for the reported allegation was identified. During the analysis, it was identified that some of the sync cable connector leads were damaged and the solder connections between the sync cable connector leads and the handheld pcb were cracked. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. An analysis was performed on the returned flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3786359
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dennis100
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« Reply #125 on: January 20, 2019, 01:18:23 AM »

Model Number MODEL 250
Event Date 05/07/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was stuck at the alignment screen. A hard reset was performed and the screen reloaded and went back to the alignment screen, but the user was unable to proceed from that screen. No patient's were affected as the physician has another handheld to you. A new programming tablet was provided to the physician and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Additional information was received stating that the handheld device¿s screen had cracked which caused the reported issues. Visual analysis of the handheld was able to verify that the display was cracked. The cause for the cracked screen is associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3853491
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dennis100
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« Reply #126 on: January 23, 2019, 01:50:52 AM »

Model Number MODEL 250
Event Date 06/06/2014
Event Type  Malfunction   
Event Description
Analysis of the handheld was completed on (b)(4) 2014. A visual analysis of the handheld was able to verify that the display was cracked. The cause for the cracked screen is associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Once the screen was replaced, no further anomalies associated with the handheld were noted during testing. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
The company representative reported that he went to use his handheld and the screen was cracked. He reported that the screen was no longer responsive due to the crack and a hard reset did not resolve the issue. It was reported that the handheld had not been handled roughly and it is unknown how the screen became cracked. The company representative was provided a new programming computer and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913728
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dennis100
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« Reply #127 on: January 23, 2019, 01:51:34 AM »

Model Number MODEL 250
Event Date 06/05/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the handheld device was unresponsive and stuck at the menu screen. The handheld device was able to perform interrogations but would be unresponsive once it reached the menu screen. The handheld has been returned to the manufacturer for analysis. A visual analysis of the handheld was able to verify that the display was cracked. The cause for the cracked screen is associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910831
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dennis100
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« Reply #128 on: February 02, 2019, 07:45:37 AM »

Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Event Description
The handheld and related software were received by the manufacturer for analysis. However, analysis has not been completed to date. It was noted that the handheld was received with a cracked screen, but the company representative reported that it was not cracked prior to shipment. Therefore, it was damaged in the shipping to the manufacturer.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the handheld device history record confirmed all quality specifications were passed prior to distribution.
 
Event Description
An analysis was performed on the returned handheld and software, and the reported allegation could not be verified. The handheld display and touchscreen were damaged during shipping and were no longer functional. A visual analysis of the handheld was able to verify that the display was cracked. The cause for the cracked screen is associated with mishandling of the device as previously reported. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis.
 
Manufacturer Narrative

Event Description
It was reported that the handheld dell x50 was unresponsive to touch. A hard reset was attempted, but when the align screen prompt was received, the screen was unresponsive to touch. A replacement product was provided. The product has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4180848
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dennis100
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« Reply #129 on: February 02, 2019, 07:46:14 AM »

Model Number MODEL 250
Event Date 08/08/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the tablet was completed on 09/22/2014. A visual analysis of the tablet was able to verify that one of the inner glass layers of the display was cracked. As a result of the cracked glass, the display image was also distorted. No other anomalies were observed during the analysis.
 
Event Description
It was reported that half of the vns programming tablet screen did not function and appears cracked. The product was returned to the manufacturer. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4055964
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dennis100
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« Reply #130 on: February 09, 2019, 01:20:54 AM »

Model Number 302-20
Device Problem Mechanical Problem
Event Date 01/04/2019
Event Type  Malfunction   
Event Description
It was reported that during the patient's generator replacement surgery the surgeon found a "crack" on the outer layer of the patient's lead. It was reported that the inner layer was still in tact. System diagnostic tests were performed before and after the replacement surgery and indicated the lead impedance was within normal limits. The surgeon made the medical decision not to replace the lead at the time of the surgery. No relevant surgical intervention for lead replacement 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=8276156
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dennis100
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« Reply #131 on: February 17, 2019, 05:50:53 AM »

Model Number 302-20
Device Problems Break; Crack; Battery Problem
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 the physician reported that high impedance had been observed on a system diagnostics test. The high impedance was first seen on (b)(6) 2015. It was stated that there was no known direct trauma to the device that could have caused or contributed to the high impedance.
 
Event Description
On (b)(6) 2015 it was reported that the patient¿s lead seems to have ¿cracked/broken¿. Per the physician, an x-ray was taken which showed a disruption in one of the leads about 1 cm superior to the generator. It was also reported that the patient¿s battery is at end of life as it has been implanted almost 12 years. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was stated that there was no report of high impedance prior to the consult. The patient underwent a full revision surgery on (b)(6) 2015. The explanted products could not be returned for product analysis as the hospital discards them. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
On (b)(6) 2015 it was reported that the explanted lead and generator would be returned for product analysis. They have not been received to date.
 
Event Description
Product analysis was completed on the leads on (b)(4) 2015. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 199mm portion the end of the connector pin quadfilar coil appeared to be broken approximately 192mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on a second broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The area on a third broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture and no pitting. Flat spots and pitting was observed on the coil surface. During the visual analysis of the returned 7mm portion the end of the quadfilar coil appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with fine pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and abraded open / cut areas found on the outer silicone tubing and the cut ends that were made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded open / cut found on one of the inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On 10/13/2015 the generator and lead were received for product analysis. Product analysis was completed on the generator on 10/27/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 0. 50 years remaining before the eri flag would be set. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the end-of-service condition is an expected event. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570324
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dennis100
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« Reply #132 on: March 07, 2019, 01:32:46 AM »

Model Number 302-30
Device Problem Positioning Problem
Event Date 09/03/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient was hyper-sensitive to the pain, so initially it was believed that there was nothing wrong other than the presence of the device causing pain. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 due to the chest pain as well as painful stimulation. Pre-operative diagnostics revealed normal impedance of 1,590 ohms. During the replacement surgery, the surgeon observed a crack in the lead insulation with some fluid inside. There was no known trauma which caused this. The lead was not revised.
 
Event Description
It was reported that the patient was having pain at her vns generator implant site and thus was wanting the device repositioned. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5106217
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dennis100
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« Reply #133 on: March 21, 2019, 12:10:30 AM »

Model Number MODEL 250
Event Date 08/24/2015
Event Type  Malfunction   
Event Description
It was reported that the tablet device was dropped and the tablet screen cracked. The tablet device was returned to the manufacturer which verified that the display was cracked. The cause for the cracked screen is associated with mishandling of the tablet. Additionally during the analysis it was identified that the tablet would not emit a completion noise following an interrogation. The cause for the anomaly is associated with the device driver not being properly installed during the os installation. Reinstalling the os is the recommended fix for this condition. No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5197466
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« Reply #134 on: March 26, 2019, 01:18:16 AM »

Model Number MODEL 250
Device Problem Charging Problem
Event Date 12/14/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A company representative reported that a tablet programmer would not hold a charge. No patients were affected. The tablet programmer was returned to the manufacturer and is currently undergoing product analysis.
 
Event Description
During product analysis the tablet programmer performed according to all functional specifications. The tablet was not received with a power supply adapter so the tablet's main battery was fully charged successfully using a known good power supply adapter. The tablet was powered on continuously and was used to program and interrogate a pulse generator multiple times using only the main battery for more than an hour. The main battery had a remaining charge of 81% at the conclusion of the testing. No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. Follow up with field representatives revealed that the power adapter used in the field to attempt to charge the tablet is not available to be returned for product analysis. The field representative reported that the tablet had a crack at the top near the power source. Product analysis confirmed the tablet had a cracked case consistent with the field report but the function of the tablet was not adversely affected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5353704
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dennis100
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« Reply #135 on: April 24, 2019, 12:45:54 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/01/2017
Event Type  Malfunction   
Event Description
A patient underwent surgery to resolve painful and erratic stimulation in the neck and chest that began in (b)(6) 2017. The device had previously been programmed off after the patient complained that the pain sensation intensified with greater output currents. Diagnostics for the device were within the normal limits. The surgery was for patient comfort and was not required to preclude a serious injury. The generator was explanted during surgery 5 months later. Generator diagnostics were performed independent of the lead during surgery and revealed no anomalies with the performance of the generator. The existing lead was examined for obvious damage, and a company representative identified a hairline crack near the connector boot of the lead. The lead reportedly became more pronounced when the lead was twisted. The lead appeared to have been cut during a previous surgery, but the surgeon could not confirm the cause of the fracture. The surgeon and company representative believed that the lead fracture was the likely cause of the painful stimulation. The surgeon elected to repair the lead using adhesive. The now-repaired lead was connected to a new generator, and diagnostics returned results within the normal limits. The device was programmed on, and the patient reported feeling the stimulation at multiple parameter sets; however, the sensation of stimulation was no longer painful to the patient. The explanted generator was not returned to the manufacturer. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6840804
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« Reply #136 on: April 26, 2019, 06:08:54 AM »

Model Number MODEL 250
Event Date 11/02/2016
Event Type  Malfunction   
Event Description
It was reported that a physician was having issues with his programming system. The physician's handheld was frozen at the main screen and he was unable to make any selections. A hard reset was performed twice with no changes. The physician was unable to see if the pins on the flashcard were bent. There was also a reported crack on the handheld's screen that may have contributed to the issues. The handheld was reportedly sent to the manufacturer but has not been received to date.
 
Event Description
The tablet and the software were both returned and had product analysis completed. The software was verified to have no issues with responses on the touchscreen. The tablet cracked screen was verified and when it was replaced with a known good tablet, no further anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6121892
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« Reply #137 on: May 11, 2019, 12:42:32 AM »

Model Number 300-30
Device Problem Mechanical Problem
Event Date 03/22/2019
Event Type  Malfunction   
Event Description
An implant card was received indicating that there was broken insulation on the lead. Further follow up confirmed that the surgeon observed significant cracking to the casing of the lead during a surgery for a generator replacement case for battery depletion. The surgeon proceeded with a full revision (replacement of the lead and generator), and the compromised lead was not tested for an impedance reading. It was noted that the lead impedance was not tested since the surgeon planned to upgrade the patient from a dual pin system to a single pin system. Therefore, the surgeon did not want to risk wasting a dual pin generator to perform diagnostics on the lead to possibly find out if there was high impedance. The explanted product has not been received to date, and no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519930
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« Reply #138 on: June 03, 2019, 04:19:54 AM »

Device Problem High impedance
Event Date 07/27/2017
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that the patient had a generator replacement surgery that was occurring due to battery depletion of the generator. During the surgery, it was stated that the surgeon felt he might have broken the lead. The patient's mother then stated that the lead issue could have started before the replacement surgery since the patient had not been able to feel magnet stimulation in a while. The lead was replaced due to the possible high impedance issue. The explanting facility historically does not return explanted devices, so product return is not expected. No additional relevant information has been received to date.
 
Event Description
Further information was received from the physician that there was no trauma that had occurred for the patient before hand that could have led to the lead break. The surgeon also stated that he was not aware of any high impedance being observed during pre-op diagnostics. The cause of the lead break was stated to be that it "was kinked and cracked when we exposed/explanted it. " it is unclear if the damage was observed upon exposing the lead or caused by the exposing of the lead. Further inquiry was done with the neurologist who stated that he had not heard about a report of the magnet not working for the patient from the patient or the mother.
 
Event Description
It was reported by the physician that he believed that the patient's leads were out of position and that the patient was not actually receiving stimulation. It was determined that this was a reference to the vns electrodes. Follow up with the surgeon revealed that the electrodes were found to be attached to the patient's vagus nerve in the expected manner at the replacement surgery. The surgeon stated that the cause of the lead failure was the crack in the lead near the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822941
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« Reply #139 on: June 07, 2019, 05:00:31 AM »

Model Number 302-30
Device Problems Low impedance; Device Contamination with Body Fluid
Event Date 04/12/2019
Event Type  Malfunction   
Event Description
Patient presented for low battery generator replacement. The generator was unable to be interrogated due to the depleted battery. After the generator was replaced low impedance was observed on the replacement generator upon interrogation. The surgeon then proceeded with replacing the lead. It was noted that the generator site was irrigated and that it was ensured that the pin was properly inserted multiple times and the low impedance did not resolve. During lead revision, it was noted that the lead was cracked and that there was fluid inside of the lead. The explanted product has not been received by product analysis. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8586997
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