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dennis100
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« Reply #120 on: May 11, 2019, 12:45:04 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Initial report was that the generator's septum plug came out of the generator during lead pin insertion during surgery. The surgeon attempted to replace the septum plug and it was noted that the septum plug would not seat properly in the generator. The lead insertion was noted to be without difficulties. A backup generator was used in place. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution. The product was received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506083
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dennis100
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« Reply #121 on: May 14, 2019, 12:51:36 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2011
Event Type  Injury   
Event Description
It was reported by the patient¿s mother that her son has more seizures when his battery reaches 25%, and that the neurologist increases the keppra dose to counteract the seizures. The patient had generator replacements in 2007, 2011, 2015, and is scheduled for replacement currently. The increase in seizures in 2007 is reported under mfr. Report # 1644487-2007-01077, the increase in seizures in 2015 is reported under mfr. Report # 1644487-2019-00636, and the increase in seizures in 2019 is reported under mfr. Report # 1644487-2019-00652. This report concerns the increase in seizures in 2011 and subsequent generator replacement. The generator replacement was initially reported to be prophylactic. The explanted generator was later received by the manufacturer and an analysis was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator¿s header was found to be detached, but based on the observed tool marks on the pulse generator case it is very likely that this occurred during or after the explant procedure. Other than the header anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491278
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dennis100
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« Reply #122 on: May 14, 2019, 12:52:27 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; Fluid Leak; High impedance
Event Date 01/12/2015
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed. No information was initially provided. An implant card was later received showing the patient underwent a full vns revision. The diagnostics for the old device showed high impedance. It was also explained that the lead had visible "holes" and fluid within the silicone tubing. Diagnostics with a new generator and the old lead still showed high impedance. Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve. The new generator was tested using the resistor pin and confirmed good diagnostics. Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve. Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens. Once both the lead and the generator were replaced, diagnostics were within normal limits. The explanted generator and lead were reported to be discarded after the surgery.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
The programming history database was reviewed and no anomalies related to the high impedance was noted. Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance. Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6461922
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dennis100
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« Reply #123 on: May 18, 2019, 12:38:59 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 05/05/2017
Event Type  Malfunction   
Event Description
It was reported that a generator's septum plug became detached during implant surgery. The septum plug was reportedly stuck to the hex screwdriver. The septum plug was then reattached to the generator header. System diagnostics were performed and returned normal values. No other abnormal instances occurred during the surgery. The physician opted to leave the generator implanted in the patient. A review of the manufacturing record for the generator confirmed it had passed all quality inspections prior to release for distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6598123
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dennis100
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« Reply #124 on: May 18, 2019, 12:39:44 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 02/11/2017
Event Type  Malfunction   
Event Description
It was reported the patient underwent repositioning surgery for patient comfort. During the surgery, the surgeon had unscrewed the setscrew so that the vns generator could be removed from the lead for repositioning. It was noted the septum was no longer lying flat and it was explained that it could be pushed back down flush as it likely dislodged while unscrewing the setscrew. It was later explained the vns generator had to be replaced as the septum popped out when the surgeon attempted to push it back down flush. The device history record was reviewed and confirmed the vns generator passed all tests prior to distribution. The vns generator was received by the manufacturer. While analysis is expected, it has not been completed to date.
 
Event Description
Analysis was completed on the received generator however it was noted that the septum was not received. During analysis the generator performed to functional specification. During dimensional assessment, the header septum cavity was measured and found to be outside of specification (higher than the maximum upper limit). The header lead cavity was measured and found to meet specification. Receiving inspection documentation was reviewed for the lot of septum cavities used to manufacture the generator. No anomalies were observed with the sampled septum cavities. A company representative reported that the following explant the generator left the or and underwent a process prior to being returned to the manufacturer. It was unclear what type of sterilization process the generator may have been exposed to that could have potentially affected the dimensions of the septum cavity. Further follow-up with the explanting facility found that there was no record of the generator undergoing additional sterilization after explant and prior to return to the manufacturer. The cause of the out of specification septum cavity could not be determined as it was unclear if the generator was exposed to additional sterilization after explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600771
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dennis100
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« Reply #125 on: May 18, 2019, 12:40:39 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device when interrogated. The patient had an x-ray performed where it was stated no break could be seen. The x-rays have not been reviewed by the manufacturer to date. The patient was referred for a lead replacement due to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent surgery where the vns generator was replaced and the high impedance resolved. No fractures were observed at the time of the surgery so the lead was not initially replaced. The explanted generator was tested on its own and found to be functioning properly. After the surgery the device was programmed on and intermittent high impedance was observed. This indicated that there might be an intermittent microfracture. The patient was returned to the operating room and the lead was replaced. Impedance was then within normal limits with the new lead and generator. The explanted lead and generator was discarded following the surgery.
 
Event Description
The manufacturer received two user facility medwatch reports related to the events previously captured in this report, (b)(4).
 
Event Description
It was reported that the explanted products were actually not discarded and were available for return. The products have not been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "the explanted lead and generator were received" this information was inadvertently left off on mfg. Report #3. Corrected data: device available for evaluation?; this information was inadvertently left off on mfg. Report #3.
 
Event Description
The explanted lead and generator were received and underwent product analysis. The generator performed to functional specification during analysis. No anomalies were observed during a series of diagnostic tests and interrogations. It was noted only a portion of the lead was received and the segment did not contain the electrodes. Upon visual analysis it was found that the lead¿s pin had two full sets of set screw marks, indicating proper contact between the generator and lead had existed at one point in time. However there was a single set screw mark near the end of the lead pin which indicated that proper contact was not occurring at one point in time. It was unclear when this partial connection occurred. The lead's connector boot was partially detached and there were abrasions near the connector boot. The reason for the partial detachment and abrasions was unknown. Abrasions were noted in the outer tubing in multiple locations and there was fluid inside the inner and outer tubing. The only obvious point of entry was the end of the lead that had been cut during the explant and the abrasions in the outer tubing. Continuity testing was performed on the lead and no discontinuities were identified within the returned lead portion. Other than the abraded outer insulation, no other anomalies were identified in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6603299
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dennis100
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« Reply #126 on: May 18, 2019, 12:41:27 AM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery. The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur. The lead could not be implanted due to the high impedance/insertion difficulties. The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values. A different lead was implanted and post-op impedance values were all within normal limits. The lead that was not implanted has not been received by the manufacturer to date.
 
Event Description
The lead that was unable to be inserted was returned to the manufacturer for analysis. The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin. Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits. A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant. Continuity checks of the returned lead assembly verified that there were no discontinuities present. The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of 0. 135 in max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. This lead had both characteristics. The lead's large o-ring boot diameter was 0. 134 in, which is close to the 0. 135 inches specification max and therefore, may cause pin insertion difficulties. In addition, review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604102
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dennis100
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« Reply #127 on: May 18, 2019, 12:42:11 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that the septum plug fell out when the surgeon when he took it out to insert the lead. The generator was not used and the patient was implanted with a different generator. The suspect device was received and was returned due to "faulty generator/loose screw. " 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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was performed on the returned generator and showed that the pulse generator performed according to functional specifications. Detachment of the septum plug was observed ¿as received¿ prior to decontamination, which may possibly be implant-related damage. The returned setscrew shows mechanical wear on the socket (suggesting numerous insertion attempts) and septum debris is in the socket (verifies the setscrew was extracted up into the septum). In addition, the returned septum shows damage on the underneath side, which indicates the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the septum plug. The header septum cavity and returned septum meets specification requirements. Other than the noted septum plug detachment, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6453706
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dennis100
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« Reply #128 on: May 18, 2019, 12:42:52 AM »

Model Number 304-20
Device Problems Detachment Of Device Component; Fracture
Event Date 04/27/2017
Event Type  Malfunction   
Event Description
It was reported that a neurologist observed high impedance on a patient's device during a clinic visit. The neurologist reported that high impedance was not observed during the previous clinic visit (b)(6) prior. The patient's family also reported that she had fallen during her seizures. The patient was referred for surgery. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient's father reported that the patient was experiencing an increase in seizures due to the high impedance. According to the patient's father, the surgeon believed that the lead may have become dislodged from the patient's vagus nerve. The patient underwent full revision surgery. The surgeon and company representative confirmed that the electrode had become dislodged from the nerve, but the surgeon did not know what caused the electrode to come off of the nerve. The explanted lead and generator were discarded and are unavailable for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6586456
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dennis100
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« Reply #129 on: May 20, 2019, 09:14:57 PM »

Model Number 102
Device Problem Detachment Of Device Component
Event Date 04/19/2017
Event Type  Malfunction   
Event Description
It was reported that during a prophylactic generator replacement surgery, the explanted generator was found to have a detached header. The surgeon stated the generator had been implanted under the muscle so he believes that put more pressure on the generator and caused the header to break off. Review of the manufacturing records for the generator revealed no anomalies during the manufacture of the device. The explanted generator was received 05/05/2017. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on the initial report that the pre-operative diagnostics were within normal limits. (b)(4).
 
Event Description
Pre-operative diagnostics were within normal limits. Analysis was completed for the returned generator. The reported detachment of the header was confirmed. The detachment of the generator header was most likely the result of inadequate adhesive application during manufacture. A lack of adhesive was found on the can and header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566110
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