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dennis100
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« Reply #150 on: January 26, 2018, 02:26:23 AM »

Event Date 08/30/2010
Event Type Malfunction
Event Description
Reporter indicated that an unk pt who had recently been implanted with a vns was nearing end of service. The reporter questioned if the end of service could have been affected by electrocautery. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1865231
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dennis100
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« Reply #151 on: January 28, 2018, 01:50:05 AM »

Model Number 103
Event Date 09/03/2010
Event Type Malfunction
Event Description
Reporter indicated that during a vns lead replacement surgery, the generator was interrogated and found to have zero years remaining on the battery with a "vbat disabled" message. The lead was being replaced due to the pt being in a fight which caused trauma to the vns lead, and the generator was not previously at end of service. It is suspected that cautery used near the generator during the surgery, damaged the generator. A new generator was implanted and the suspect generator was returned for analysis. Analysis of the generator is pending.

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=1859779
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dennis100
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« Reply #152 on: February 09, 2018, 10:57:47 AM »

Model Number 106
Device Problem High impedance
Event Date 12/15/2017
Event Type Malfunction
Event Description
A patient underwent generator replacement surgery. Diagnostics on the explanted device were within the normal limits. The existing generator was then explanted, and the new generator was introduced into the field. The physician then used electrocautery to resize the pocket. The new generator was connected to the existing lead and high impedance was observed. The lead pin was removed and reinserted into the generator, and the high impedance message was observed again. The lead was then connected to the previous generator, and impedance was within the normal limits. The lead was then connected to the new generator and high impedance was observed again. A test resistor was then inserted into the new generator, and high impedance was observed during a generator diagnostic test. Finally, a third generator was connected to the lead, and normal impedance was observed. The third generator was implanted in the patient, and the generator displaying high impedance was returned to the manufacturer for analysis. Analysis has not been approved for the returned generator to date. The company representative present at the surgery confirmed that both the lead pin and test resistor pin were fully inserted into the generator each time the device was tested, and she noted that two clicks were heard, confirming that the setscrew had been tightened adequately. The company representative reported that the generator was not dropped at any time, but she was unsure if the electrocautery present in the field may have affected the performance of the generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7177070
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dennis100
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« Reply #153 on: February 10, 2018, 01:54:32 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 10/05/2017
Event Type Malfunction
Event Description
It was reported that product analysis had been completed on a patient's generator that had been explanted due to battery depletion. Product analysis showed the generator had reached end of service and could not be interrogated. Data from the generator showed that only about 18. 703% of the battery had been consumed at that point. Burn marks were also observed on the generator case, indicating possible exposure to an electro-cautery tool. Postburn electrical tests were run on the generator and multiple tests failed. Product analysis found remaining residual material on the pcba edge which originated from the test tab removal process. This resulted in excess current consumption. A review of the device history record indicated the generator had been manufactured using the laser-routing process which is known to produce conductive debris and result in current leakage pathways. No other relevant information has been received.

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dennis100
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« Reply #154 on: March 08, 2018, 02:19:00 AM »

Model Number MODEL 250
Event Date 05/23/2012
Event Type Malfunction
Event Description
Further investigation was performed in-house, however the event could not be replicated.

Event Description
It was reported from a neurologist's office that during the interrogation of the patient's generator, an ifi flag warning was observed on the patient's device. This was the first time the physician's office had ever observed the warning. When the button was selected, it would repeatedly appear and with no progression to the programming menu. The handheld computer being used was a (b)(4). A hard reset was then performed, and the patient's device was reinterrogated and the issue would repeat with no progression to the programming menu. After the hard reset, the warning appeared approximately 8-10 times before another (b)(4) handheld computer was used. After interrogation, the same event occurred. Then, a (b)(4) handheld computer was used which confirmed an ifi flag, but the site was able to click to proceed only three times before progressing to the programming menu. The patient's device was able to be successfully programmed at that time with the (b)(4) computer. Attempts for a copy of the flashcards from the neurologist's office and the handheld used at the surgeon's office are in progress, but the copied programming history has not been received to date. The issue with the other (b)(4) handheld computer and its related software is reported in manufacturer report number: 1644487-2012-01507.

Event Description
The implant card was received and confirmed the generator replacement surgery on (b)(6) 2013 was due to battery depletion with near end of service=yes.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's referral for generator replacement. The notes indicate that the generator is now showing "end of service: yes" upon interrogation. Although surgery is likely, it has not occurred to date. The notes also mentioned that the patient continues to average 4-6 small seizures per month.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2013 that the patient had generator replacement surgery on (b)(6) 2013 due to battery depletion. The generator was returned to the manufacturer, however product analysis has not been completed to date. The return product form indicated the reason for replacement was due to end of service with eri=yes.

Event Description
Analysis of the explanted generator was completed. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicates that the pulse generator may have been exposed to an electro-cautery tool, as captured in mfg report number: 1644487-2010-01474. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The reported premature end of life and asic latch-up condition allegations were duplicated in the pa lab (associated with the pulsedisabled by the pulse generator). With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 377 volts, indicating a near end of service condition. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. Other than the noted errors, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Type of report, corrected data: the initial report inadvertently did not report that this is a '30 day report. '.

Event Description
Additional information received that now the generator is indicating neos = yes which the physician believes is premature however it is already known that the generator has been hit with electrocautery which will impact the battery capacity. Clinic notes dated (b)(6) 2012 were received for the patient who has been referred for generator replacement surgery due to neos=yes. The notes also indicated that the patient was experiencing breakthrough seizures, but the frequency appeared to be the same as previously noted and related to poor medication compliance. Although surgery is likely, it has not occurred to date. Manufacturer report number 1644487-2010-01474 captures the asic latch-up condition as a result of using electrocautery during implant surgery.

Event Description
Copies of the physician's flashcard and flashcard data from the date of surgery was received and analyzed via decoder spreadsheet where it was confirmed that on (b)(6) 2012, the battery voltage was 2. 679 confirming ifi = yes. However, the used charge accumulation was 17. 952% indicating that the battery was not depleting at an expected rate. Further review of a previous report where it was reported that during the patient's initial implant, a "vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616861
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dennis100
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« Reply #155 on: March 13, 2018, 12:26:53 AM »

Model Number 302-20
Event Date 07/26/2012
Event Type Malfunction
Event Description
Analysis of the generator was previously completed on (b)(6) 2012, but mistakenly not included on the previous report. Analysis found the generator performed to specifications and no anomalies were found. Additional information was later received as an implant card indicating the reason for replacement was "lead discontinuity" and "prophylactic generator replacement". The lead impedance following the surgery was noted as "ok".

Manufacturer Narrative

Event Description
It was reported that the vns patient was scheduled for a lead revision due to high impedance. Additional information was received indicating that surgery to replace the patient's lead as well as replace the patient's generator prophylactically has occurred. The explanted products have been returned for analysis. Analysis of the lead has been completed. The electrode portion of the lead was not returned. A discontinuity was observed in the negative coil and a partial discontinuity was observed in the positive coil at the same location however the discontinuities appear to be related to electrocautery being used during surgery. Based on the pitting present at the site of the discontinuities, it is likely that the discontinuity was present with stimulation for some time. It is unknown whether the electrocautery damage occurred during the previous generator replacement on (b)(6) 2011 or at the recent replacement surgery on (b)(6) 2012. The generator is still undergoing analysis. Attempts for additional information have been unsuccessful to date. No adverse events have been reported.

Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently indicated that the "generator is still undergoing analysis" however analysis had been completed at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2714587
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dennis100
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« Reply #156 on: March 15, 2018, 01:46:20 AM »

Model Number 105
Event Date 08/22/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during surgery to replace the patient's vns generator, the generator indicated eos after being placed in the pocket. Diagnostics prior to placing the generator in the pocket were normal. A company representative present at the surgery indicated electrocautery had been used; however, it was not used near the generator. A back-up generator was implanted. The faulted generator was returned and underwent analysis. Analysis confirmed the generator was returned in a pulse disabled condition due to a perceived low battery voltage. After the output was re-enabled, the generator performed to specifications. No burn marks such as those created by use of electrocautery were observed on the generator can. Review of generator source code from the surgery indicates the generator was functioning normally until an event occurred resulting in a sudden drop in the battery voltage such as exposure to electrocautery or an electrostatic discharge. The cause of the pulse disabled event is unknown. No adverse events have been reported as a result of the issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754721
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dennis100
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« Reply #157 on: March 25, 2018, 01:34:10 AM »

Model Number 304-20
Device Problems Unintended collision; Improper or incorrect procedure or method; Device displays error message; Extrusion
Event Date 10/01/2015
Event Type Injury
Event Description
It was reported that the vns patient was picking at the neck incision site and subsequently caused extrusion of the lead. The patient underwent surgery on (b)(6) 2015 and the patient's lead was replaced prophylactically. During the procedure, the patient's generator was inadvertently hit by electrocautery and the device subsequently showed a vbat < eos threshold message. Battery status prior to surgery showed ok. The generator was also replaced during the procedure. The explanted lead has been returned to the manufacturer where analysis is currently underway. Analysis of the returned lead will be reported in this manufacturer report. The explanted generator was returned to the manufacturer for analysis which was reported in manufacturer report # 1644487-2015-06497.

Manufacturer Narrative

Event Description
Analysis of the returned lead was completed. Scanning electron microscopy images of the lead coils at the exposed portions and at the cut ends show that the coils were exposed some type of electro-cautery tool. Based on the appearance of the returned lead this was most likely caused at explant. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.

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dennis100
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« Reply #158 on: March 28, 2018, 12:35:43 AM »

Model Number 104
Event Date 11/29/2012
Event Type Malfunction
Event Description
Additional information was received that product analysis was completed on both generators. The premature eol was duplicated in the product analysis lab for the new generator with the suspected issue. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Despite the lack of physical evidence on the case exterior, high energy exposure is a likely cause. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing (following a reset of the pulse disable bit) indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 1. 564% of the battery had been consumed. The second generator was returned due to prophylactic replacement and low battery ifi=yes. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the product analysis lab. The battery is partially depleted, 2. 805 volts (near ifi) as measured. The data in the diagaccumconsumed memory locations revealed that 91. 045% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Additional information was received that it was confirmed that electrocaudary was used while the generator was in the sterile field.

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Manufacturer Narrative

Event Description
It was initially reported while the patient was having a generator replacement there was an issue with the new generator. Diagnostics were run on the generator prior to implant outside the pocket and they were within normal limits. Once the patient was implanted and the generator was in the pocket the generator was showing eos-yes. A resident was performing the surgery under the supervision of vns implanting physician. It is unclear if electrocautery was used during the surgery near the generator but is possible. The patient was implanted with a different generator and all diagnostics were within normal limits. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2889406
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dennis100
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« Reply #159 on: April 21, 2018, 12:27:37 AM »

Model Number 103
Event Date 03/08/2011
Event Type  Malfunction   
Event Description
It was reported that the patent had generator replacement surgery on (b)(6) 2013. The explanted generator was received by the manufacturer on (b)(6) 2013. However, product analysis has not been completed to date. Attempts for additional information have been unsuccessful to date.
 
Event Description
During this review of the vns programming history database for this vns generator on (b)(4) 2013, it was identified that the device was in a pulse disabled state due to "vbat

Event Description
Analysis of the generator confirmed the output pulse disabled condition. The reported asic latch-up condition allegation was duplicated in the laboratory. Based on the vns programming history database and the as received condition of the generator suggest that exposure to an electro-cautery tool (as burn marks were observed on the generator) which may have been a contributing factor. The device performed according to functional specifications after output was re-enabled. A non-operating crystal oscillator was also observed most likely related to high energy exposure. In the lab, the generator would not interrogate. The generator was opened. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 591 volts, indicating an neos condition. The generator could not be interrogated with either the handheld or (b)(4) software. When the crystal was checked for oscillation, with the oscilloscope probe, communication with the generator was possible. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. The calculated (from ram and flash data) vbat voltage did not reflect the bench-measured vbat voltage of the pulse generator (post open can). Analysis of the generator showed that monitor was being loaded down. A cause for the electrical loading could not be determined, but it may be related to the electro-cautery exposure.
 
Event Description
The return product form indicated the reason for generator replacment as battery depletion with eri=yes.
 
Event Description
The implant card confirmed that the patient had generator replacement surgery on (b)(6) 2013 for battery depletion with near end of service condition.
 
Manufacturer Narrative

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Manufacturer Narrative
Review of the manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3127699

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dennis100
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« Reply #160 on: April 30, 2018, 12:20:49 AM »

Model Number 304-20
Event Date 08/20/2012
Event Type  Injury   
Event Description
It was reported that the patient had vocal cord paralysis as determined by an ear nose and throat doctor. The vocal cord paralysis began shortly after implant surgery. It was stated that the patient's device was turned on, and that as of (b)(6) 2013, the patient's voice issues have improved since initially noted after the replacement. Follow up with the neurologist's office found that the vocal cord paralysis was observed in (b)(6) 2012. Hoarseness and pain in the vocal cord area were also observed around this time after implant surgery. Per the neurologist's office, the ent checked the patient and found that the left vocal cord was immobile. As of the last visit, the patient had a scope done and the left vocal cord was still immobilized. In regards to intervention, it was only known that the patient was taking speech therapy. The hoarseness and vocal cord paralysis is constant and not with stimulation. It is unknown if the pain was with stimulation. The patient has been programmed on since surgery to previous settings. The following parameters were provided - output current = 0. 5ma, pulsewidth = 30 microseconds, magnet output current = 1ma. It was unknown if the patient has a medical history of vocal cord paralysis; however, it was stated that the paralysis occurred shortly after surgery. In particular, it was stated stated that the vocal cord paralysis occurred due to the patient being burnt with the leads. It was stated that the burn occurred while transferring the battery and replacing the leads. The physician's staff stated that, per the notes, a new set of leads were connected into the generator and no impedance issues were found. The area was irrigated. No other information was provided to clarify what was meant by the patient was burnt as this was all the information that was available. It was unknown if the burn referred to electrocautery or if electrocautery was used during surgery. It was said that a video swallow study was performed which was negative for aspiration. Diagnostics were all ok. No other information was provided. Attempts have been made for additional information; however, no additional information has been provided.

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dennis100
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« Reply #161 on: May 06, 2018, 01:09:47 AM »

Model Number 103
Event Date 07/31/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the generator "shorted out" during the initial implant surgery. Prior to implant surgery, the generator was checked and confirmed to be functioning properly. However, during implant surgery, the manufacturer's representative observed that electrocautery was used in the pocket while the generator was in the pocket. Diagnostics were then run and found eos=yes (pulse disabled). The patient was implanted with a different generator and the "shorted out" generator was returned for product analysis. No other information has been provided.
 
Event Description
The generator analysis was completed on (b)(6) 2013. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse condition found with the pulse generator.
 
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3309449
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dennis100
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« Reply #162 on: May 09, 2018, 12:30:48 AM »

Model Number 103
Event Date 07/12/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's device was explanted due to premature end of life. Product analysis of the explanted generator was performed on (b)(6) 2013. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 6. 035% of the battery had been consumed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3335839
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dennis100
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« Reply #163 on: June 04, 2018, 12:09:06 AM »

Model Number 103
Event Date 09/30/2009
Event Type  Malfunction   
Event Description
It was reported to the mfr that the vns pt went through a prophylactic generator replacement. The explanted generator was returned to the mfr for product analysis. Diagnostics performed on the pt's device prior to the surgery were within normal limits, indicating proper device function. Upon interrogation in the product analysis lab, the following message appeared: "pulse generator is currently disabled due to v-bat less than eos threshold". This event was found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within spec. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Discoloration was observed on the can of the generator which is an indication that some sort of electrical energy source may have been used on the device during the explant procedure. The reported eos condition was not verified during the pa analysis; however, the output therapy was disabled due to a perceived low voltage threshold crossing. Investigation determined that the likely root cause of this event is due to an application-specific integrated circuit (asic) latch-up condition, resulting from the generator receiving an electrical transient during surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). The emi and/or esd causing the asic latch-up can be attributed to the use of electrosurgery in direct contact with the generator, electrosurgery in close vicinity to the generator or a major electrostatic discharge.

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dennis100
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« Reply #164 on: June 06, 2018, 01:50:31 AM »

Model Number 103
Event Date 11/09/2009
Event Type  Malfunction   
Event Description
It was reported that a vns pt's generator was explanted due to pain at the generator site. The explanted generator was returned to the mfr and underwent product analysis. Product analysis performed on the returned generator revealed an end of service warning message which was associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The reported eos condition was not duplicated during the pa analysis. Capa (b)(4) further investigated the eos condition of the generator and revealed the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge. The pain event is further reported in mfr report # 1644487-2009-02675 along with the product analysis of the generator.

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« Reply #165 on: June 08, 2018, 02:19:43 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 05/02/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was undergoing generator replacement surgery, and the new lead was connected to the lead outside of the pocket. Diagnostics were within normal limits at that time. The surgeon then placed the generator in the pocket, and the device was communicated with again. The battery was at end of service, even though it had full battery prior to being placed in the pocket. The company representative that was present at the surgery could not see if electro-cautery equipment was in the field while the generator was being implanted or if the metal part of the hex screwdriver was touched while screwing the set screw in. Data from the surgery was reviewed, which showed that the device was functional prior to the surgery and then, within three minutes, the generator was at end of service. This is possibly indicative of the device being hit with electro-static discharge, but there is not enough evidence at this time to determine if that was the definitive cause of the malfunction. The device history record of the generator was reviewed, and the device performed to specification prior to release. The generator has been received, but analysis has not been approved to date.

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« Reply #166 on: June 09, 2018, 12:59:44 AM »

Model Number 104
Device Problem Energy output to patient tissue incorrect
Event Date 04/24/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a generator replacement surgery due to battery depletion. Diagnostics was performed on the replacement generator while still in the packaging and the diagnostics were within normal limits. However, upon connecting the replacement generator to the implanted vns lead, high impedance was observed and the vns generator battery was at vbat < eos. The high impedance was reported in mfg. Report #1644487-2018-00804. The diagnostics also indicated that a high output current status was observed, which is reported in this mfg. Report. The surgeon stated that he may have touched the metal part of the torque screwdriver. The company representative stated that electrocautery was present in the field when the new generator was being implanted. A backup generator was implanted and a full vns replacement surgery occurred. The suspect generator was received by the manufacturer and is pending product analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7524130

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« Reply #167 on: July 06, 2018, 08:14:40 AM »

Model Number 104
Device Problem Premature end-of-life indicator
Event Date 02/15/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient¿s generator settings spontaneously changed to 0ma and the physician reports that the patient¿s battery was only 25% and the device was implanted less than one year ago. Data from the patient's device was received and reviewed. It was seen that the device was set to vbat < eos threshold when the device was interrogated on (b)(6) 2018. All outputs at this time were set to 0 ma including the magnet output. Lead impedance was within normal limits. The device was then programmed back on to desired settings. From reviewing the data, the generator is functioning properly and thus the only explanation for why the generator was at settings of 0ma upon interrogation is that the generator was likely in contact with some form of electrocautery on or around (b)(6) 2018. This may have been caused by event non-invasive procedure where possible electrocautery or radio frequency tools were used. As far as the generator¿s performance right now, all impedance values are within normal limits and the voltage of the battery (battery longevity) appears normal and was not significantly affected by this electrocautery use. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7570257

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« Reply #168 on: September 04, 2018, 08:21:21 AM »

Model Number 302-20
Event Date 06/03/2011
Event Type  Malfunction   
Event Description
Reporter indicated no x-rays were performed. The explanted lead and generator were returned for analysis. No anomalies were identified with the generator and the generator performed per specifications. A break in the positive lead coil was identified near the anchor tether helical area. An abraded opening was identified in the inner tubing of the negative coil (at approximately 0. 7-0. 9 cm past the electrode bifurcation). Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However; due to metal dissolution and surface contamination, the fracture mechanism cannot be determined. Also, scanning-electron microscopy images of the exposed area of the negative coil indicate the coil was exposed to some type of electro-cautery tool. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified within the returned lead portions. Review of the decoder programming history for the returned generator revealed high lead impedance occurred on (b)(6) 2011. On this date, the ohms value increased from 2338 to 13124.
 
Manufacturer Narrative
Model #, lot #, expiration date, corrected data: the initial manufacturer report incorrectly reported this information. This report is being submitted to correct this data. Manufacture date, corrected data: the initial manufacturer report incorrectly reported this information. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a patient had high lead impedance with vns diagnostics testing. It was not known if any trauma had occurred. The patient later had vns generator and lead replacement surgery performed. Attempts for return of the explanted devices are in progress.
 
Manufacturer Narrative
Date of event, corrected data: the correct event date is provided. Device failure occurred, 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=2225433
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« Reply #169 on: October 11, 2018, 06:03:23 AM »

Model Number MODEL 250
Event Date 05/23/2012
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's referral for generator replacement. The notes indicate that the generator is now showing "end of service: yes" upon interrogation. Although surgery is likely, it has not occurred to date. Surgery will be captured in manufacturer report number: 1644487-2012-01508. The notes also mentioned that the patient continues to average 4-6 small seizures per month.
 
Event Description
Copies of the physician's flashcard and flashcard data from the date of surgery was received and analyzed via decoder spreadsheet where it was confirmed that on (b)(6) 2012, the battery voltage was 2. 679 confirming ifi = yes. However, the used charge accumulation was 17. 952% indicating that the battery was not depleting at an expected rate. Further review of a previous report where it was reported that during the patient's initial implant, a "vbat
 
Manufacturer Narrative

Event Description
Additional information received that now the generator is indicating neos = yes which the physician believes is premature however it is already known that the generator has been hit with electrocautery which will impact the battery capacity. Clinic notes dated (b)(6) 2012, were received for the patient who has been referred for generator replacement surgery due to neos=yes. The notes also indicated that the patient was experiencing breakthrough seizures, but the frequency appeared to be the same as previously noted and related to poor medication compliance. Although surgery is likely, it has not occurred to date. Manufacturer report number 1644487-2010-01474 captures the asic latch-up condition as a result of using electrocautery during implant surgery.
 
Manufacturer Narrative
Type of report, corrected data: the initial report inadvertently did not report that this is a '30 day report.'.

Event Description
Further investigation was performed in-house, however the event could not be replicated.
 
Event Description
It was reported from a neurologist's office that during the interrogation of the patient's generator, an ifi flag warning was observed on the patient's device. This was the first time the physician's office had ever observed the warning. When the "proceed" button was selected, it would repeatedly appear and with no progression to the programming menu. The handheld computer being used was a (b)(4) x5. A hard reset was then performed, and the patient's device was reinterrogated and the issue would repeat with no progression to the programming menu. After the hard reset, the warning appeared approximately 8-10 times before another (b)(4) x5 handheld computer was used. After interrogation, the same event occurred. Then, a (b)(4) x50 handheld computer was used which confirmed an ifi flag, but the site was able to click to proceed only three times before progressing to the programming menu. The patient's device was able to be successfully programmed at that time with the (b)(4) x50 computer. Attempts for a copy of the flashcards from the neurologist's office and the handheld used at the surgeon's office are in progress, but the copied programming history has not been received to date. The issue with the other (b)(4) x5 handheld computer and its related software is reported in manufacturer report number: 1644487-2012-01508.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616753
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« Reply #170 on: October 31, 2018, 01:17:05 AM »

Model Number 103
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
During a repositioning surgery a recently implanted generator was found to be at end of service. It is believed that electorcaudary was used during the surgery and caused the end of service condition. The generator was replaced that day as a result. Attempts for additional information have been unsuccessful. The repositioning surgery and the events leading to it will be reported on medwatch 1644487-2014-02493.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Model #, serial #, lot#, expiration date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect. Device manufacture date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect.
 
Event Description
It was reported that the generator was discarded during surgery; therefore, no product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4121637
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« Reply #171 on: December 07, 2018, 08:55:42 AM »

Model Number 105
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were also observed on the pulse generator can and header, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status was ok. Other than the noted condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that during generator replacement surgery the new generator "checked out fine" until the incision was closed. It was reported that once the incision was closed the new generator then displayed end of service upon device testing. The new generator was then replaced with another new generator which was tested and was within normal limits. It was reported that no electrocautery was used after the first generator was implanted and that the surgeon is very conscious of electrocautery use and the generators. Attempts have been made to have the generator returned for analysis; however, the generator has not been received to date.

Event Description
Additional information was received which indicates that there is an rf device present in the operating room during vns surgeries which may create radiofrequency in the room. It was stated that this device appears near the end of surgery when they are closing the patient. No additional information has been provided.

Event Description
It was reported that the generator would be returned for analysis. The generator was received 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=3272619
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« Reply #172 on: January 04, 2019, 08:57:50 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/27/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a surgery to move the patient's port to the opposite side from the vns. Prior to the procedure the patient's device was turned off and the battery status showed the 75% indicator. After the procedure, the device showed the neos battery status and a message was seen stating that output current was low. It was stated that bovie (electrocautery) was used during this port surgery. The patient later underwent a vns generator replacement surgery and it was found that the battery status was no longer depleted. System diagnostics at this replacement surgery were reported to be normal. The generator was replaced and has been received by the manufacturer. An analysis is underway but has not been completed to date a review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180656
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« Reply #173 on: January 20, 2019, 01:44:44 AM »

Model Number 103
Event Date 03/31/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery. No other relevant information has been received to date.
 
Event Description
It was reported that diagnostic tests were taken on the generator prior to implanting of device outside of the pocket and after device was in the pocket. The test before implant showed the battery was not at near end of service condition, but the test after the generator was in the pocket showed that the device was at end of service condition. It was reported that the generator was not cold prior to implant. The physician decided to continue implanting the generator. The manufacturer's or specialist that attended the surgery did not see cautery come in contact with the generator, but the cautery device was lying on the patient when the generator was introduced. The surgeon also submerged the generator in a tray with antibiotic solution prior to implant. The manufacturer investigated the programming data available from surgery. The voltage dropped from 3. 287v to 1. 884v during the surgery. The initial interrogation (before implant) and system diagnostics were at ifi = no, and the subsequent diagnostics (after implant) measured between 1. 884v and 1. 988v. The drop in voltage is an indicator that the device likely came in contact with an electro-cautery device or an electrostatic discharge, causing the asic latch-up condition. Electro-cautery is known to potentially cause battery depletion and its usage is warned against in labeling. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5594516
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« Reply #174 on: January 31, 2019, 02:07:19 AM »

Model Number 106
Event Date 09/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery the new generator was connected to the lead and the device was interrogated when a low battery vbat's eos message. The generator had been interrogated while still in the packaging and an end of service warning did not present. The generator was then detached from the lead a new generator was implanted. It was noted that electro-cautery equipment was present in the sterile field while the generator was present. The physician was informed by a company representative that the manufacturer does not recommend keeping electro-cautery equipment in the sterile field once the new generator has been introduced to the sterile field. The manufacturing records of the premature end of service generator were reviewed and found that the generator passed quality inspection prior to distribution. Programming data from the day of the attempted implant was reviewed and it confirmed that prior to implant the battery voltage was not at end of service. However a subsequent diagnostic test found that the battery voltage was at end of service. Additionally it was noted that the generator's temperature had increased when the end of service warning was observed. The suspect generator has not been received to date.
 
Event Description
Product analysis was completed on the m106 generator. During visual analysis noted that the generator had burn marks which indicate that the generator was exposed to electro-cautery. Upon initial interrogate the generator was in a eos = yes pulse disabled condition. The pulse disabled byte was reset and the generator was interrogated. The battery indicator was then eri = no. The generator then performed to functional specification. Based on the burn marks on the generator's case and the report that electro-cautery was used during the surgery. It appears that the premature battery indicator was the result of coming into contact with electro-cautery during the implant procedure.
 
Event Description
The generator has been received and is currently pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6016730
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« Reply #175 on: February 06, 2019, 02:34:11 AM »

Model Number 103
Event Date 11/12/2014
Event Type  Malfunction   
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the generator was connected to the lead and system diagnostic results showed normal device function. The generator was disconnected and the surgeon began creating the generator pocket. The generator was reconnected and placed in the generator pocket; however, subsequent diagnostic results showed a near end of service condition. At the patient¿s follow-up appointment, the patient¿s device showed a pulse disabled message. The physician elected to program on the patient¿s device. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient¿s device had reached the intensified follow-up battery status indicator. Diagnostics were reported to be normal.
 
Event Description
Follow-up was received from the patient¿s new neurologist that the patient was referred for replacement as the battery was low. A review of the manufacturer¿s in-house programming history was performed. On the date of implant (b)(6) 2014, systems diagnostics showed the impedance was within normal limits and the battery voltage was 3. 261 volts. Upon a second diagnostics test during implant surgery the generator showed an end-of-service condition, and the battery voltage dropped to 1. 897 volts. On (b)(6) 2016 diagnostics testing showed the voltage had recovered, and impedance values were within normal limits. The battery voltage reached the 25% indicator on diagnostics performed on (b)(6) 2016 with a voltage of 2. 846 volts. It had been reported by the company representative that electrocautery was used near the generator during the implant surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative

Event Description
Replacement surgery occurred. The explanted device was provided to be discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326482
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« Reply #176 on: February 13, 2019, 01:34:22 AM »

Model Number 103
Device Problems Device Displays Incorrect Message ; Battery Problem
Event Date 01/19/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was implanted and programmed on to previous device settings. The patient¿s device was then tested and showed a near end of service condition. Electrocautery was not used during the procedure. Pre-operative diagnostic results of the replacement generator showed ok battery status. The patient¿s device was tested again the next day and showed pulsedisabled due to ¿vbat
 
Manufacturer Narrative
 
Event Description
Analysis was completed on the explanted generator and shows a pulse disabled condition had occurred and confirms the pulse generator was programmed out of the event on (b)(6) 2015 (implant (b)(6) 2015). The battery, 2. 701 volts as measured during completion of test parameter (measured diagvbat) of the final electrical test, shows an ifi=yes condition. The data in the diag accum consumed memory locations revealed that 18. 203% of the battery had been consumed. A battery life calculation resulted in 4. 9 (minimum 4. 0) years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the hardware reset condition. No device failure found during product analysis, the premature end of life condition was confirmed by product analysis as due to the pulse disabled event from an electro-cautery tool usage at implant.
 
Event Description
Additional information was received that at the follow up visit on (b)(6) 2015 the battery was showing 100% of charge; on the (b)(6) 2015 that battery was showing 30% of charge remaining. Review of the decoder data provided showed on the interrogation on (b)(6) 2015 the battery voltage (vbat) was 3. 545volt; however the "pulse disabled" incorrectly showed vbat< eos threshold which was not the case as the currently measured vbat 3. 545v is > to 2. 0v. The battery status indicator is 100%, in line with the measured vbat 3. 545v. On the next programming step on (b)(6) 2015, the measured voltage was the same, vbat 3. 545v with "pulsedisabled" showing "enabled" with no eos flag. No further eos flag showed on the next visits.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. It was reported that the generator was explanted due to device failure. The explanted generator was returned to the manufacturer on 12/15/2015. Analysis is underway but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519027
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« Reply #177 on: March 04, 2019, 08:07:04 AM »

Model Number 104
Event Date 06/16/2015
Event Type  Malfunction   
Event Description
It was reported that during the patient's generator replacement, a new generator was opened and attached to the patient's leads. However, when diagnostics were run, it was reported that the new device showed both high impedance (>10,000 ohms) and end of service. A generator diagnostics was also performed with the test resistor in the generator, which also reportedly showed high impedance and eos. Thus, a new generator was taken from inventory and successfully implanted in the patient with normal impedance and battery status. The opened but unused generator has been returned to the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis of the explanted generator was completed. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant/explant. Review of the ram/flash data downloaded from the generator showed that no diagnostics were performed on the pulse generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 096 volts as measured during completion of the final electrical test, shows an ifi=no condition.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4899414
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« Reply #178 on: March 19, 2019, 01:13:37 AM »

Model Number 103
Event Date 10/26/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient was picking at the neck incision site and subsequently caused extrusion of the lead. The patient underwent surgery on (b)(6) 2015 and the patient's lead was replaced prophylactically. During the procedure, the patient's generator was inadvertently hit by electrocautery and the device subsequently showed a vbat < eos threshold message. Battery status prior to surgery showed ok. The generator was also replaced during the procedure. The explanted devices were returned to the manufacturer for analysis. An end-of-service warning message was displayed by the pulse generator and found to be associated with the output being disabled. Burn marks were also observed on the pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. The data in the diagaccum consumed memory locations revealed that 4. 621% of the battery had been consumed. Other than the pulse-disabled condition there were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the returned lead is currently underway and will be reported in manufacturer report # 1644487-2015-06498.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5239806
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« Reply #179 on: March 19, 2019, 01:14:18 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported on 10/28/2015 that this patient has high impedance. The patient had a recent generator replacement on (b)(6) 2015. The impedance when the new generator was connected was ok at 1187 ohms. The patient was doing some work, lifting shingles on her roof a couple of days ago and it is unknown if this may have caused the issue. No further relevant information has been obtained to date.
 
Event Description
The patient's generator and lead were both replaced on (b)(6) 2016. During the replacement, pin reinsertion was not performed and the surgeon simply proceeded with the replacement. The high impedance resolved with lead replacement, but the surgeon decided to replace the generator because he used electro-cautery when removing the old battery that resulted in damaging the device. The sales representative did re-train the surgeon on the importance of not using electro-cautery when the generator is not being explanted. The explanted devices were discarded after surgery.
 
Manufacturer Narrative
Describe event, corrected data, a new mfr. Report was created to house all further events for the generator premature eol.
 
Event Description
Mfr. Report # 1644487-2016-00837 created to house the report of electro-cautery being used when removing the old battery that resulted in damaging the device. All follow-up information for that depleted generator battery will be housed in that mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5243110
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