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dennis100
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« Reply #30 on: November 29, 2015, 03:52:36 PM »

Model Number 300-20
Device Problems Improper or incorrect procedure or method; Device operates differently than expected
Event Date 06/25/2015
Event Type Malfunction
Event Description
Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that. Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

Event Description
It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015. At this time the pulse width was increased from 250 to 500. Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain. Device was turned off again and it helped for a while but the issues did not resolve. System diagnostics show result of high impedance. It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the patient underwent surgery on (b)(6) 2015. It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar. Instead, the surgeon implanted a new vns generator and lead on the right side of the patient. The lead was implanted on the right vagal nerve. The patient and family agreed with the surgeon and therefore the old devices were not touched. The surgeon was informed of the cardiac risks of implanting vns system on the right side. The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected. Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907360
« Last Edit: January 06, 2016, 12:30:59 PM by dennis100 » Logged
dennis100
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« Reply #31 on: November 30, 2015, 06:57:55 AM »

Model Number 103
Event Date 05/22/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4). Additional manufacturer narrative; corrected data: the previously submitted mdr inadvertently lacked the udi number of the suspect device for the event.

Event Description
It was reported that the vns patient underwent a lead replacement due to high impedance reported in the mfr. Report # 1644487-2015-05011. The replacement lead was implanted on the right vagus nerve. The existing generator was tested upon connection to the new lead and system diagnostics returned high impedance. The existing generator was explanted and a replacement generator was connected to the new lead. The new vns system was tested and system diagnostics returned impedance within normal limits. The explanted device has not been returned to the manufacturer to date.

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=4867413
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dennis100
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« Reply #32 on: December 02, 2015, 01:54:24 AM »

Model Number 304-20
Event Date 03/17/2015
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient had undergone a full vns system replacement on (b)(6) 2015 due to lead discontinuity. System diagnostics on the new vns system returned lead impedance within normal limits, 1801 ohms. Review of the available programming and diagnostic history showed diagnostics results within normal limits through (b)(6) 2012. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted generator and lead have not been received for analysis to date.

Event Description
Further information was received indicating that the generator was replaced prophylactically, as it had been implanted for four years. Furthermore, the old lead was implanted on the right side, and the new one was implanted on the left side, and the surgeon considered it was more practical and safer to implant a new generator. A lead fracture was obvious on the old lead, approximately 10 cm distal to the generator connection. The explant of the lead did not include the electrode array.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4738799
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dennis100
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« Reply #33 on: December 12, 2015, 01:00:09 PM »

Model Number 304-20
Event Date 04/16/2014
Event Type Malfunction
Event Description
Review of x-rays by manufactuer was unable to be determined if the connector pin of the lead was fully inserted inside the connector block on the generator. There are no apparent sharp angles or gross fractures of the lead that could be seen in the images given. There was nothing seen that would indicate there was any damage to the generator or lead causing a high impedance condition; however, the presence of a micro-fracture in the lead or incomplete pin insertion cannot be ruled out.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, no gross lead discontinuities visualized.

Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The generator was received by the manufacturer and analysis is currently underway. The lead will not be returning; therefore, no analysis on the lead can be completed. During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed low impedance (<=600 ohms).

Manufacturer Narrative
Review of the available programming and diagnostic history.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the explanted generator was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that device diagnostics resulted in high impedance (6585 ohms). The physician chose to leave the device programmed on because the patient has had great efficacy. X-rays were performed. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

Event Description
Clinic notes dated (b)(6) 2015 note that the patient has experienced poor seizure control for the past year. Device diagnostics again resulted in high impedance (>7,000 ohms). The notes indicate that the physician is considering right sided placement of the vns since the patient has previously undergone generator and lead replacement on the left side. It was noted that the patient will undergo vns revision and the new system will be placed on the right side. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277356
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dennis100
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« Reply #34 on: December 14, 2015, 10:22:03 AM »

Event Date 10/13/2014
Event Type Malfunction
Event Description
It was reported that the patient underwent lead replacement surgery due to lead discontinuity. The new lead was placed on the patient's right vagus nerve. An implant card was received indicating that both the generator and lead were replaced. The explanted devices have not been received for analysis to date.

Event Description
It was reported that the vns patient responded well to vns which reduced her seizure frequency to one per month. The patient recently began experiencing an increase in seizures and pain in her neck. During an office visit on (b)(6) 2014, the patient¿s device showed high impedance. The patient¿s medications were subsequently increased. X-rays were taken and reported by the radiologist to show lead discontinuity. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245782
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dennis100
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« Reply #35 on: December 14, 2015, 11:45:03 PM »

Event Date 08/20/2014
Event Type Injury
Event Description
It was reported that during planned implant surgery the surgeon was unable to locate the patient's vagus nerve, so the surgery was cancelled. The patient was referred to an ent for evaluation and mri, so the surgeon could visual the patient's anatomy at the time of implant. It was later reported that the patient has a congenital absence of the left vagus nerve (no large nerve in the sheath). The patient will undergo imaging to check vocal cord function before considering right sided implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4198932
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dennis100
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« Reply #36 on: December 19, 2015, 09:45:47 AM »

Model Number 103
Event Date 04/25/2014
Event Type Injury
Event Description
It was reported that the patient had an infection at the generator site. The surgeon planned on taking out the generator and "wiping it off". Further follow-up revealed that the patient underwent generator replacement at which time the new generator was implanted on the patient's right side of the chest. It was reported that the infection was observed right after the implant surgery. No cultures were performed.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3843719
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dennis100
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« Reply #37 on: December 20, 2015, 03:30:38 AM »

Model Number 105
Event Date 03/11/2014
Event Type Injury
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect age. Date of event, corrected data: the initial report inadvertently reported the incorrect date.

Event Description
It was reported that the patient was re-implanted with vns on (b)(6) 2015. Due to infection surrounding the left vagal nerve previously, the surgeon elected to implant on the right vagus nerve based on his medical judgment.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the recently implanted vns patient went to the emergency room on (b)(6) 2014 due to a seizure. The patient had a fever and was admitted to the hospital that day for a possible infection at her incision site. The patient was discharged on (b)(6) 2014. The patient¿s device was tested at the hospital and reported to be functionally normally. The neurologist stated that the patient¿s seizure was due to her device being programmed to a low output current (0. 25ma). The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to infection. Wound cultures from the patient¿s lead incision site were taken but the results have not been provided. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3812438
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dennis100
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« Reply #38 on: December 21, 2015, 12:28:44 PM »

Event Date 02/26/2014
Event Type Malfunction
Event Description
It was reported that the patient will be seen by ent for thyroid biopsy and evaluation and when that is complete the patient will be scheduled for generator and lead replacement. No surgical intervention has been performed to date.

Event Description
It was reported that the vns patient was experiencing and increase in seizures. The patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 9405 ohms). X-rays were provided to the manufacturer for review and the cause for the reported events could not be determined. There was a suspect area near the anchor tether which may be a possible break. There was nothing additional seen that would indicate there was any damage to the generator or lead. As the entire lead could not be assessed from the x-rays provided, continuity in that portion of the lead cannot be confirmed. Attempts for additional relevant information were made, but have been unsuccessful to date. No known interventions have occurred to date.

Event Description
Additional information was received indicating that the vns patient¿s increase in seizures was below pre-vns baseline levels. The patient was seizure free since (b)(6) 2011. The patient was now having 12 seizures per day that were increasing in intensity and duration. The patient was referred for surgery but no known interventions have occurred to date.

Event Description
Additional information was received that the explanted generator and lead were discarded and will not be returned to the manufacturer for evaluation.

Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014. The patient¿s generator was explanted, but the lead remained implanted due to concerns of potential damage to the patient¿s nerve. The explanted generator was discarded. A new generator and lead were implanted on the right side of the patient¿s body.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a potential lead discontinuity. Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3705843
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dennis100
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« Reply #39 on: December 22, 2015, 01:26:11 AM »

Model Number 103
Event Date 02/18/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Electrocautery was used in a port-a-cath procedure on( b)(6) 2014 that caused the generator battery to drain. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

Event Description
It was reported that during an unrelated surgery the patient's generator was repositioned to the patient's right chest. The surgeon wanted to verify that the generator was working properly. The physician performed diagnostics which showed the generator was at neos. The surgeon confirmed that electrocautery was performed. The patient had not been prior consented for generator replacement; therefore, the generator could not be replaced at that time. It was later reported that the patient would be referred for generator replacement. Surgical intervention has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3688612
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dennis100
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« Reply #40 on: December 22, 2015, 09:20:17 AM »

Model Number 102
Event Date 01/21/2014
Event Type Injury
Event Description
It was reported that the patient was scheduled to undergo generator relocation to the right chest due to an infection. The physician reported that the generator site was washed out and the generator was relocated to the right side of the chest. No patient manipulation or trauma occurred that is believed to have caused or contributed to the infection. It was reported that cultures were taken and showed mrsa. The patient is being treated with antibiotics.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3672716
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dennis100
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« Reply #41 on: December 22, 2015, 09:20:57 AM »

Model Number 102
Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt experienced episodes of bradycardia. The pt is implanted with two vns therapy systems, one on the left side and one on the right side. Only the left-sided system had been programmed to on, but treating neurologist recently programmed the right-sided system to on as well, to provide additional assistance in breaking the pt's seizzure patterns. The episodes of bradycardia occured while both systems were programmed to on. This treatment plan did not change the pt's seizure pattern, so the right-sided system was programmed back to off. It was reported that the episodes of bradycardia occurred while the pt was hospitalized for treatment of sub-clinical status and that while hospitalized, their heart rate periodically dropped to approximately 40 beats per minute. The pt was reportedly intubated during their hosp stay because versed and prescribed to stop the seizures. The seizures lessened but did not stop. The pt's feeding tube came out of their stomach and pt subsequently aspirated. Versed was discontinued. Propofol was prescribed, after which the pt's brain wave pattern "calmed down", but the seizures continued. Propofol was then replaced with fentanol, in an effort to bring the pt out of the drug-induced coma. The pt began seizing again, so the fentanol was replaced with pentobarbital. The pt developed pneumonia during this time. Pentobarbital was discontinued, after which the pt experienced a few seizures that were stopped with initiation of prescribed for treatment of the vocal cord swelling. The pt's conditon slowly improved and pt was discharged home after approximately 24 days of hospitalization. Device diagnostic testing on the left-sided system was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Review of manufacturing records for both the pulse generator and the bipolar lead (left-sided system) revealed no anomalies that would adversely effect device performance. It is believed that the episodes of bradycardia were caused by excessive stimulation as a result of both the left-sided and right-sided vns therapy systems being activated at the same time.

Event Description
Patient's left vns therapy system was replaced. It is believed that a portion of the vagus nerve was 'dead' due to the scar issue build up after a prior infection. Prior to the surgery on 2/16/06, patient was hospitalized in a vegtative state, the cause of which was unknown. The patient had experienced 30+ grand mal seizures and complex partial seizures in one day prior to surgery. During the replacement surery, the lead wires were put under the muscle per family's request. The surgeon did not open up the old wound site and the lead wa placed high upon the vagus nerve. Prior to surgery, patient's device was set to 1. 75 ma, signal frequency of 25 hertz, pulse width of 250 microseconds, on time of 30 seconds, off time 0. 8 minutes, magnet current of 2. 00 ma, on time of 30 seconds, pulse width 250 microseconds. Battery life estimation using these device settings indicate approximately 1. 3 years to the elective replacement indicator (eri). During the surgery the device settings were set to the patient's settings pre-surgery and the patient was not able to tolerate them. As a result the patient suffered pain. The family used the magnet to diable the device until the device could be reprogrammed. The patient is now set at 0. 5 ma, 25 hertz (signal frequency), 250 microsecond (pulse width), on time of 30 seconds, 3. 00 minutes off, magnet setting of 250 microsecond pulse width, signal frequency of 30 seconds and magnet current of. 75 ma. Follow up indicates as of 2/23/06 the patient's grand mal seizures had reduced from 15+ per night to 1 or none. As of 3/3/06, patient was reported to be doing better from a seizure standpoint, experiencing 50-60 absence seizures a day, no drop seizure and a generalized tonic seizure at night. As of 3/13/06 the patient is not on any current medications and the seizures have drastically improved since re-implantation.

Manufacturer Narrative
H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potental adverse event possibly associated with surgery or stimulation. The vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=578597
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dennis100
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« Reply #42 on: December 24, 2015, 12:33:00 AM »

Model Number 302-20
Event Date 11/12/2013
Event Type Malfunction
Event Description
It was reported that the patient underwent lead replacement due to high impedance (10,000 ohms). It was reported that x-rays did not show a lead fracture or any abnormalities. It was reported that the patient experienced a good clinical response with vns. Pre-operative diagnostics identified that the generator had not yet been programmed off. The device was programmed off prior to the patient going to the operating room. It was reported that the surgeon decided to implant the new lead on the patient's right vagus nerve. The lead was cut at the connector pin and the explanted portion was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. 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=3547746
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dennis100
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« Reply #43 on: December 25, 2015, 01:06:44 PM »

Model Number 304-20
Event Date 10/03/2013
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and normal mode diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was not disabled following the high impedance observation. The patient¿s physician stated that the patient¿s lead likely cracked from the patient¿s seizures. A mass was noted on the patient¿s neck during an office visit on (b)(6) 2013. The patient¿s radiology exam stated that the sonographic findings were most consistent with a hematoma at the patient¿s left neck. An abscess was not expected based on the absence of fever, wbc count, and the overlying redness and swelling.

Manufacturer Narrative

Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance was observed on (b)(6) 2013.

Event Description
On (b)(6) 2013 it was reported that the patient has high lead impedance. The patient had a fall with seizures approximately 3 weeks ago striking her neck area and developed a hematoma in the neck. When her vns was checked, she was found to have high impedance. It was stated that the surgeon was treating the hematoma with cold and warm compresses but the hematoma did not go down. No x-rays were taken due to patient¿s ¿mr¿ (possibly mental retardation). Patient went to surgery on (b)(6) 2013 to have a full revision but when the surgeon opened the left neck he saw a huge hematoma that entwined the nerve including the part where the helices were. The surgeon said he would not implant another lead/generator on the left side because of the extensive hematoma. The surgeon then elected to place the lead and the generator on the right side due to the severe hematoma and resulting scar tissue on the left side. The explanted lead and generator have not been returned to the manufacturer for product analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3494999
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dennis100
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« Reply #44 on: December 27, 2015, 03:40:58 AM »

Model Number 105
Event Date 09/09/2013
Event Type Injury
Event Description
It was reported that the patient was scheduled for repositioning surgery. However, it has not been confirmed to date that the surgery occurred.

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently reported this information incorrectly. Implant date, give date, corrected data: the initial report inadvertently reported this information incorrectly.

Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 to revise the generator pocket and move the generator from the patient¿s left chest to her right chest.

Manufacturer Narrative

Event Description
It was reported by the patient's husband that the vns device was "working its way out" and that this was the third time the vns generator had done this. The patient went in for surgery to reposition the device due to the migration and the skin showing signs of potential breakdown. The vns battery was not replaced. Upon follow up, it was found that the generator was not extruding from the skin and there were no causal factors noted in the dictated notes that may have caused it. The nurse's notes indicate the patient's device was implanted in (b)(6) 2013, but over the last few weeks, the patient noticed increased tenderness and redness around the generator area, as well as some irritation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3435628
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dennis100
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« Reply #45 on: December 27, 2015, 11:44:49 AM »

Model Number 302-20
Event Date 09/06/2013
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that high impedance was observed while the patient was still in the hospital following generator replacement (due to prophylactic reasons). During the surgery on (b)(6) 2013, diagnostics were within normal limits; however, on (b)(6) 2013, the device was showing about 7000 ohms when interrogated. Per the physician, the patient did not have any falls while in the hospital. During a review of the patient's x-rays, it was noted that the patient appears to have the lead on the right-hand side. There were no observed gross fractures noted. The lead pin insertion issue cannot be ruled out as potential cause since the surgeon has a history of quickly going through that step during surgery. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388730
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dennis100
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« Reply #46 on: December 27, 2015, 11:45:25 AM »

Model Number 102
Event Date 09/03/2013
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description
It was reported that the patient had an infection at the generator site. It was reported that the infection was caused by the patient's saliva and patient care. It was reported that cultures showed staph aureus. The surgeon relocated the generator to the right side of the patient's chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3381666
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dennis100
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« Reply #47 on: January 01, 2016, 10:13:21 AM »

Model Number 103
Event Date 12/16/2011
Event Type Injury
Event Description
On (b)(6) 2013, it was reported by the nurse that the vns patient has learning disabilities and behavioral difficulties and that keeping the neck wound clean was very difficult.

Event Description
On (b)(6) 2012 it was reported that the patient had their generator and lead explanted due to an infection and that they were going to be re-implanted. The timeline of events were provided to be the following; on (b)(6) 2011 the wound site was tender to the touch and on (b)(6) 2011 the neurosurgeon assessed the event and thought it to be a superficial infection. On (b)(6) 2012 the wound was washed out and re-sutured. On (b)(6) 2012 the vns was explanted due to the unresolved infection. On (b)(6) 2012 they attempted to implant the device again but when the surgeon opened him up, he felt that the scarring and risk of infection was too great. Therefore it wasn¿t until (b)(6) 2013 that a new vns system was able to be implanted, but on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
On (b)(6) 2013 the nurse reported that she cannot provide any further information.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3147650
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dennis100
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« Reply #48 on: January 05, 2016, 12:36:16 AM »

Model Number 103
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
The ap and lateral chest x-ray report was provided by the physician¿s office which reported the patient had a history of chest pain. The vns generator was observed in the anterior chest walls with leads terminating within the left lower neck. No anomalies were noted by the radiology group. The patient had a prophylactic generator replacement surgery on (b)(6) 2013. The patient wanted the generator placed on the right side versus the left side (off-label). The explanted generator was received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date. The implant card reported the reason for replacement as prophylactic and confirmed the date of surgery as (b)(6) 2013. Lead impedance following surgery was okay.

Event Description
The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2012 with no further seizures noted since vns increased. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. Product analysis was completed on the explanted generator. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead impedance prior to surgery was within normal limits.

Manufacturer Narrative

Manufacturer Narrative
The first sentence was inadvertently listed the date as (b)(6) 2013 incorrectly on the initial report as it should have read as (b)(6) 2012. Additionally, the information in the second paragraph inadvertently reported the date of events incorrectly. This information was from clinic notes dated (b)(6) 2012.

Event Description
It was reported that he patient was referred for generator repositioning surgery due to the device shifting around. Follow up with the treating ent's office revealed that the patient was at the office on (b)(6) 2013. The patient has been complaining of pain for the last year or year and a half. The pain has been so bad that the patient went to the surgeon who decided to replace the device. The plan is due replace it on the right side of the chest, off-label because the patient's skin is so irritated. The patient has been wearing a lidoderm patch all the time, and it looks like the lead wires are too close to the skin so it's been rubbing. No patient psychological changes were mentioned, nor any patient manipulation or trauma. It is unclear why the device migrated as the nurse indicated that she does not remember this being a problem after the implant in 2008. The patient is unable to function due to the irritation and pain and the patient is left-handed. The nurse indicated that there is the possibility in the future that "it could come out of the device" (detachment of lead). Attempts for additional information from the surgeon have been unsuccessful to date. Clinic notes dated (b)(6) 2012 indicated the patient returned for follow up not satisfied with seizure control reporting two partial seizures in the last eight months. No changes were made the previous visit. She reported side effects consisting of pain associated with vns. Vns was functioning properly based on diagnostics, and the output current was decreased to 0. 25ma and magnet output to 0. 75ma. The seizures were reported to mostly controlled unless provoked by stress but she has had tolerability problems so requested decreased output current. Overall, the patient was about the same from the last visit. In clinic notes dated (b)(6) 2012, it was reported that the physician's assistant (pa) adjusted the vns to tolerability on (b)(6) 2012 where the patient miscommunicated with the pa. The patient reports not having tolerability issues and did not make the request. Additionally, the pa recommended having the vns removed-something not documented in her note. The patent noticed an increase in partial seizures after vns was reduced, so the settings were increased to previous settings on (b)(6) 2013 with no further seizures noted since vns increased. Side effects were denied. However, the patient was noted to have "focal pain in the chest at the site of the vns implant that she treated with a patch. The source of this pain is not clear - it is not in the neck and is not associated with device activation, suggesting more of a mechanical process, perhaps related to scar tissue or to device movement or current leak. Interestingly, she notes increased pain at the implant site when she has a seizure, which does not make physiological sense unless she has increased sensitivity associated with her seizures. Her pain was not reduced when my former pa reduced her vns settings. She prefers not to make any major changes to her vns because she feels that it has made all the difference with respect to her seizure control. Overall, the patient is doing about the same since the last visit. The patient is satisfied with seizure control. The patient is satisfied with side effects. " chest pa and lateral x-rays were planned to assess vns placement and lead integrity. The plan was to adjust vns for tolerability after (b)(6) 2012. Clinic notes dated (b)(6) 2013 reported the patient had the vns adjusted at the last visit and the patient presented on (b)(6) 2013 reporting that everything was going well and was satisfied with seizure control. No pain was noted. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3038963
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dennis100
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« Reply #49 on: January 05, 2016, 11:58:14 PM »

Model Number 103
Event Date 08/17/2012
Event Type Injury
Event Description
Product analysis for the explanted generator and lead was completed. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Additionally, 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.

Manufacturer Narrative
Corrected data: the initial report inadvertently did not report this data. Review of manufacturing history records performed. Review of manufacturing history records of the generator and lead confirmed sterilization and all quality tests passed prior to distribution.

Event Description
The physician reported that there was no infection or related symptoms. Cultures were negative for infection. The patient had a "burning lesion" on the upper thoracic region "many years ago" correlated to difficult healing which compromised the skin around the vns generator. Therefore, the generator began extruding. Antibiotics were given to the patient orally. The generator and portion of the lead were explanted on (b)(6) 2013, but the lead electrodes were not explanted due to fibrosis. A replacement generator was implanted on the right side of the chest off-label. The patient's epileptic seizures have reduced significantly. The patient has responded well to the replacement surgery with no additional complaints, per the physician. Diagnostics after replacement were within normal limits. Product return is expected, but the devices have not been received by the manufacturer to date. The implant card confirmed the date of replacement of the generator and lead on (b)(6) 2013 with the reason marked as "dehiscence". Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that the patient was being scheduled to have generator explant and to have the device replaced later in the week due to an unknown reason. Additional information was received indicating that the suture was opened, but an infection at the site was not confirmed to date. No manipulation is believed to have caused/contributed to the event. The generator and lead were both replaced. Attempts for additional information from the physician have been unsuccessful to date.

Manufacturer Narrative

Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated that the reason for explant was 'dehiscense' the patient was later reimplanted. The physician reported that 'everything was told' so no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3021530
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dennis100
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« Reply #50 on: January 06, 2016, 12:42:43 PM »

Model Number 102
Event Date 10/05/2010
Event Type Injury
Event Description
Reporter indicated a vns patient was to have her vns generator repositioned to the right chest wall due to needing treatment for left breast cancer. The patient later had vns repositioning surgery. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1892281
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dennis100
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« Reply #51 on: January 08, 2016, 02:31:39 AM »

Model Number 103
Event Date 11/12/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was being scheduled for emergency surgery. The generator was extruding through the skin. The surgery occurred on (b)(6) 2015 for generator replacement. The extrusion was attributed to the numerous past surgeries the patient experienced at the site of her generator and subsequent scar degradation. The surgeon chose to implant the generator on the right side to avoid aggravating the site of the injury. The explanted generator was discarded after the surgery, so product return and analysis is not possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5275266
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dennis100
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« Reply #52 on: January 14, 2016, 12:53:14 PM »

Model Number 302-20
Event Date 11/14/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portions and lead break was confirmed. Note that 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 381mm and 25mm portions the outer / inner silicone tubes appeared to be abraded open / torn. During the visual analysis of the returned 381mm portion the ends of the connector pin and connector ring quadfilar coils appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. During the visual analysis of the returned 25mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken in the area of the abraded open / torn outer / inner silicone tubes. Visual analysis was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. 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. The setscrew marks found on the marked 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. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to a death or serious injury.

Event Description
A vns patient was referred for a battery change and when a new battery was used, high impedance was discovered. The surgeon noted that during electrode removal he found the lead was completely severed. Due to scar tissue and placement of electrode, a new lead was implanted on the right side. Their explanted lead has been returned for analysis. Completion is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870688
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dennis100
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« Reply #53 on: January 23, 2016, 04:48:14 AM »

Model Number 102
Event Date 01/25/2013
Event Type Injury
Manufacturer Narrative

Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914
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dennis100
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« Reply #54 on: January 24, 2016, 03:19:45 AM »

Event Date 04/27/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
A patient reported that during implant surgery, the surgeon implanted the vns generator on the right side of the patient's chest as the patient was implanted with a pacemaker on the left side. During implant, the patient experienced asystole and had to be resuscitated. During surgery, the patient also experienced a large seizure when the vns was programmed on and now the patient is having more seizures than she did prior to being implanted with the device. The patient also stated that the device is pushing up against her skin which causes pain while dressing. Per the patient, the surgeon stated that the generator battery may have been used up during surgery, and he was unsure if the device was still functioning. Follow up with the neurologist revealed that the patient has a history of arrhythmia. The generator is registering magnet swipes. He does not know if the increase in seizures is above baseline levels. The protrusion response was that the device looks no different from any other patient other than it being on the right side. He will do a symptomatic therapy for the pain and possible consultation with a surgeon for a revision of the implant if desired by the patient. He does not know of any trauma or manipulation. Good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851128
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dennis100
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« Reply #55 on: January 25, 2016, 12:50:59 PM »

Model Number 103
Event Date 09/14/2012
Event Type Injury
Event Description
It was reported that the vns patient had developed an infection a few weeks after having vns generator replacement and required explant of the vns lead and generator. The site indicated that they plan to re-implant the patient a few weeks after the infection had resolved. Attempts for additional information have been unsuccessful to date.

Event Description
The lead and generator product information was obtained. The device history records for the patient's lead and generator were reviewed and sterilization of both products, prior to shipment was confirmed. Additionally all attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received indicating the patient was scheduled for vns re-implant on the right side. Re-implant surgery reportedly occurred on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2786728
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dennis100
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« Reply #56 on: February 01, 2016, 05:48:41 AM »

Model Number 104
Event Date 05/08/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was initially reported that a vns patient underwent a full revision surgery due to an unknown reason. During the surgery, the surgeon elected to not remove the patient's previously implanted m302 lead and implant a new m304 lead on the right vagus nerve. Instead of utilizing a generator model that was compatible with the new lead, the surgeon opted to implant a dual pin m104 generator (on the left side of the chest) by inserting the single lead pin into one of the two connector blocks. As expected, subsequent diagnostic testing resulted in high impedance results and the patient has reportedly received no efficacy from therapy since the surgery. Additionally, the patient has expressed the presence of neck pain as a result of the lead extending from the left chest to the right side of the neck. The reported high impedance issue is a result of the incorrect implantation technique which has created an open circuit in the system, and not the result of a device malfunction. This is not an unexpected performance of the device, given the implant circumstances. Additionally, product compatibility is clearly listed in product labeling. Additional information from the area representative indicated the patient underwent generator replacement surgery for a single pin generator. Impedance value after replacement was ok. The explanted device will not be returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592674
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dennis100
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« Reply #57 on: February 18, 2016, 04:26:18 AM »

Model Number 302-20
Event Date 04/26/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through an implant card that a vns patient underwent lead replacement due to fibrosis. At the moment good faith attempts to obtain further information regarding the event with the reporting physician have been unsuccessful to date.

Event Description
Additional information was received through the area representative indicating the patient went to the hospital based on symptoms felt. Interventions taken according to the area representative were to disconnect the electrode and then remove it at the time of replacement. A second lead was implanted on the right vagus nerve in order to continue therapy. The explanted lead will not be returned to the manufacturer for analysis. Moreover, information from the treating physician indicated the cause of the fibrosis was likely due to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2418601
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dennis100
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« Reply #58 on: March 20, 2016, 03:17:27 AM »

Event Type Malfunction
Event Description
A vns treating physician in (b)(6) reported that they had a pt that had undergone a right sided vns implantation after a left sided lead break. Good faith attempts are underway for further details about the reported event.

Manufacturer Narrative
Device info 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=1952051
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dennis100
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« Reply #59 on: March 20, 2016, 03:17:58 AM »

Model Number 30X-UNK
Event Type Injury
Event Description
A vns treating physician reported that he had a pt who had undergone a right sided vns implantation after left sided lead break. Lead break reported in mdr report number: 1644487-2010-02958. It was reported that the pt was asymptomatic but experienced regular bradycardiac episodes during vns stimulation, lasting 30 secs. The event was observed repeatedly with drops in heart rate from 70bpm to 30bpm with stimulation, while pt was asleep and monitored. Good faith attempts are underway for further details about the reported event.

Manufacturer Narrative
Labeling recommends implantation of the lead on the left vagus nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953679
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