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dennis100
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« Reply #240 on: March 19, 2019, 12:36:29 AM »

Event Date 01/01/2015
Event Type  Malfunction   
Event Description
During a generator replacement surgery due to battery depletion, high impedance was observed with the old lead and the newly implanted generator. The surgeon indicated that the old generator was upside down and that lead was bunched up in the chest pocket prior to generator replacement. Additional information was received that three diagnostic tests were performed on the day of surgery. The lead pin was removed and reinserted completely prior to each test. During the first test (inside pocket), the impedance was 7647 ohms with output current as 0. 75 ma. During the second test with generator inside the pocket, the impedance was 7169 ohms with output current 0. 875 ma. During the third test with generator out of pocket, the impedance was 10,000 ohms with output status low and ifi - no. The surgeon also noted that there was fluid within the lead. Attempts were made for the lead product information and for the return of explanted devices but they have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225818
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dennis100
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« Reply #241 on: March 20, 2019, 10:42:37 AM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's device diagnostics showed high impedance with 9487 ohms. The patient underwent full revision surgery on (b)(6) 2015. Images of the old lead were provided from the surgery and the lead appeared to be twisted a lot. Patient manipulation is suspected as a result to be the cause of the lead fracture. The explanted devices were not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225116
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dennis100
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« Reply #242 on: March 22, 2019, 02:06:33 AM »

Model Number MODEL 250
Device Problems Cable; Connection Problem
Event Date 12/02/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A user reported that the tablet usb serial adapter cable would not attach properly to the programming wand. It was reported that the cable appeared to be bent due to apparent damage. To date, the usb serial adapter cable has not been returned to the manufacturer.
 
Event Description
The usb serial adapter cable was returned to the manufacturer for product analysis. The analysis determined that pins 4 and 5 of the db9 connector were bent, and pin 9 was missing. Once pins 4 and 5 were straightened, no anomalies associated with the cable performance were identified during the analysis. Device manufacturing records were reviewed and no unresolved nonconformances were noted prior to device distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5323377
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dennis100
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« Reply #243 on: March 22, 2019, 02:07:22 AM »

Model Number 304-20
Device Problem Battery Problem
Event Date 11/09/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015, it was reported through a product return request that the generator and lead were explanted in a planned generator replacement surgery for battery depletion. At the time, the reason for lead explant was unknown. Later communications that day established the surgeon was unable to separate the generator from the lead in surgery on (b)(6) 2015. The surgeon made efforts to manipulate the device, including completely removing the set screw as revealed by the operative report. The patient did not experience any adverse events as a result. The lead and generator have been returned to the manufacturer and are undergoing product analysis. The dhrs for both the generator and lead were reviewed and found all specifications met prior to distribution.
 
Event Description
Generator product analysis was completed on 01/05/2016, and lead product analysis was completed on 01/12/2016. During the visual analysis of the lead, the connector pin appeared to be bent. X-ray images of the products suggest the generator's canted spring was compressed, although it was also making a good electrical connection to the lead's connector ring. The pin and connector ring dimensions met lead final packaging specifications. During the visual analysis of the returned lead portions, deep canted spring indentations were observed on the connector ring surface. Continuity checks of the returned lead portions were performed and no discontinuities were identified. With the exception of the bent pin and deep spring indentations, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The bent lead pin was the likely cause of the removal difficulties and generator compressed canted spring condition. Since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The threads show damage toward the top of the generator connector block and were likely created by a tool during attempts to remove the lead in the explant surgery. The in-line cavity go gage passed insertion tests. Bench test leads were inserted and disconnected from the generator with no difficulties. All header dimensions were within specification. No additional adverse functional, mechanical, electrical, or visual issues were identified with the returned generator. A review of available programming history for the patient's generator showed no anomalies. Impedance values were within normal limits from the date of implant, (b)(6) 2012, until the last date of available history on (b)(6) 2015. A review of the dhr of the lead and generator revealed that both products passed all functional testing. As the functional testing requires pin insertion into a generator, the condition of the bent lead pin did not occur during manufacturing. Follow up communication with the implanting surgeon indicated that nothing usual was noted in the initial implant. Furthermore, good electrical contact was made as the device reported an impedance value within normal limits following pin insertion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5324616
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dennis100
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« Reply #244 on: March 23, 2019, 12:22:22 AM »

Model Number MODEL 250
Event Date 11/25/2015
Event Type  Malfunction   
Event Description
An analysis was performed on the returned tablet and the reported allegation was verified. During the analysis, it was identified that the usb port was damaged. As a result, the tablet was unable to establish communication. No further anomalies were identified.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the physician's tablet had a broken usb port and serial cables would subsequently not fit. The prongs in the usb port were visibly damaged and bent. The company representative did not know how it got damaged. No patients were affected. A replacement tablet was provided. The tablet was received by the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5301756
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dennis100
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« Reply #245 on: March 23, 2019, 12:23:05 AM »

Model Number MODEL 250
Device Problem Failure to Power Up
Event Date 12/01/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the physician's handheld won't power on at all. Even after it has been charged and the screen unlocked. The site has other devices that are able to be charged with the charger so the issue appears to be the handheld itself. The handheld was received for analysis on 12/08/2015. Analysis is underway but has not been completed to date.
 
Event Description
Product analysis was completed and approved on the hand held on 01/05/2016. Product analysis found that the handheld was able to power on and off with no observed anomalies. During the analysis it was identified that the handheld would display an error message when the returned flashcard was inserted. The cause for the anomaly is associated with a bent flashcard slot pin. Once the pin was straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5299472
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dennis100
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« Reply #246 on: March 24, 2019, 01:11:16 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; High impedance
Event Date 11/11/2015
Event Type  Malfunction   
Event Description
It was reported on 11/11/2015 that the patient had an end of service replacement that day. The physician was unable to interrogate the generator. When the new generator was connected to the existing lead, high impedance was observed around 8000 ohms. The lead was disconnected and reinserted. The physician verified that the lead pin was advanced beyond the connector block and the set screw was tightened down. Impedance was measured again and the value was over 8000 ohms. The surgeon was not able to replace the lead that day. The old lead remained connected to the new generator and the generator was left at 0. 0 ma. The explanted generator was discarded after surgery. Replacement of the lead is expected but has not been completed to date.
 
Event Description
It was reported on (b)(6) 2015 that the patient had a follow-up appointment on (b)(6) 2015 and the patient no longer has high impedance. Since intermittent impedance or a microfracture cannot be ruled out, the patient's device may still be malfunctioning. No additional relevant information has been received to date.
 
Event Description
Programming history database was reviewed on (b)(6) 2016 for the recently received model 106 generator data. History was available from date of implant, (b)(6) 2015. The system diagnostics were performed 5 times and each time resulted in high impedance. (b)(6) 2015: 8:41:57 am - ok/ok/8894/ok; (b)(6) 2015: 8:43:15 am - ok/ok/8523/ok; (b)(6) 2015: 8:47:17 am - ok/ok/9039/ok; (b)(6) 2015: 8:55:56 am - ok/ok/9026/ok; (b)(6) 2015: 8:56:38 am - ok/ok/5980/ok.
 
Event Description
Information was received 08/08/2017 that the patient¿s device was found to have high impedance in the 6,000 ohms range. X-rays were received and reviewed but could not conclusively identify a cause of the high impedance.
 
Event Description
X-rays were received and review showed there is a sharp angle in the lead body observed just proximal from the generator implant site. Full revision surgery occurred. Impedance was high in pre-op. The surgeon removed the battery and re-inserted the pin but the impedance was still high. The battery was tested alone with the test resistor, and the impedance was within normal limits. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
Further information was received that both the generator and lead were returned to the manufacturer. Product analysis was completed on both products. Analysis on the generator did not find any anomalies. The generator performed according to all specifications, and besides markings associated with explant, no visual abnormalities were noted. Data from the generator was also reviewed. High impedance was seen on the day of explant. Product analysis on the lead identified multiple coil breaks along the returned lead body. Scanning electron microscopy was performed and identified some areas as being mechanically damaged which prevented identification of the coil fracture type. Scanning electron microscopy also identified some of the fractures of being stress induced by fatigue or rotational stress. Pitting was also observed on some of the various broken coils indicating stimulation was likely present at one point. Residual material was observed on one of these broken coils. Multiple abraded openings were also noted on the outer tubing. There were also areas of abraded openings in the inner tubing near some of the fractures. This allowed fluid to breach the inner and outer tubing. White deposits were also noted along the lead body. With the exception of the observed abraded openings and discontinuities the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The electrodes were not returned and analysis could not be completed on that portion of the lead. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260887
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dennis100
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« Reply #247 on: March 24, 2019, 01:13:06 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/10/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was receiving an initial implant on (b)(6) 2015. During the surgery, high impedance was detected on the new vns system. The lead pin was disconnected and reconnected to the generator several times with additional diagnostic tests resulting in high impedance. A new lead was then opened and attached to the vagus nerve. When the new lead was connected to the generator, diagnostics again resulted in high impedance. The test resistor pin was then placed in the generator, but again diagnostics resulted in high impedance. A new generator was then opened and connected to the second lead. The subsequent diagnostic test resulted in a normal impedance value of 1,214 ohms. The surgery was then completed with these second devices implanted. The opened but unused generator and lead have not been received by the manufacturer to date. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received that diagnostics were reportedly performed as opposed to just interrogations during the implant surgery where high impedance was detected. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the suspect generator yielded no observed anomalies. The generator performed according to functional specifications. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Review of the ram/flash data downloaded from the generator shows the increased impedance was corrected; from a value of 12258 ohms to a value of 4015 ohms, and the time of change detection was (b)(6) 2015 (date of implant). This is indicative that diagnostics performed with the test resistor indeed resulted in normal diagnostic values. Analysis of the returned lead has not been completed to date. No additional relevant information has been received to date.
 
Event Description
Analysis of the returned lead was completed. A bent pin was identified in the lead connector. The identified bend of the connector pin may have been a contributing factor for the reported high lead impedance. However, the exact point in time of when this condition occurred is unknown. No other anomalies were identified in the returned lead. Programming history was reviewed for this patient and identified that only one system diagnostics test was completed during implant, which indeed resulted in high lead impedance. However, once the next lead was implanted, only interrogations were performed which continued to report the stored high lead impedance, without actually re-assessing the actual impedance. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5262758
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dennis100
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« Reply #248 on: March 24, 2019, 01:13:54 AM »

Model Number MODEL 250
Device Problems Device Inoperable; Connection Problem
Event Date 11/11/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a tablet was received by a company therapeutic consultant had a damaged usb port. The portions of the usb connector within the port on the tablet reportedly do not mechanically permit connection to the wand serial adapter. Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The tablet was returned and is pending product analysis.
 
Event Description
Product analysis was completed on 12/10/2015. It confirmed a visibly damaged 'usb connector' receptacle on the tablet with bent connector pins. The exact cause is unknown but appears to be a user-related event. However, the port could still be used for communication in the course of testing. Review of the tablet device history record confirmed that the tablet was functioning as intended during manufacture. Based on the available information, the damage likely occurred after distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5283468
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dennis100
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« Reply #249 on: March 25, 2019, 12:38:13 AM »

Model Number 302-20
Device Problems Housing; High impedance; Hole In Material; Migration or Expulsion of Device ; Material Twisted / Bent; Lead
Event Date 12/31/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the patient was scheduled for a prophylactic generator replacement (b)(6) 2015 that turned into a full replacement. When the surgeon exposed the generator for removal, he noticed that the generator was spun around with the lead twisted and the lead housing was open with a single wire exposed. No high impedance was detected prior to the replacement as impedance was 4386 ohms. The generator and lead were replaced. Follow-up showed that according to the patient's parents, he does not have the dexterity with his hands to flip the device, but they could not come up with a better rationale except they said he does rock back and forth a lot and is sometimes restrained in his chair so he doesn't fall out and they believe he may have been pushing on the device when rocking back and forth. The surgeon did visual that a suture was in place to secure the generator which was no longer attached to the generator. The explanted devices have not been received for analysis to date.
 
Event Description
The explanted generator and lead were received for analysis on 02/02/2016. The reason stated on the return product form was prophylactic and visual lead discontinuity. Product analysis for the generator completed and approved on 02/23/2016. The vns programming history database shows no data available for this generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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. Product analysis for the lead was completed and approved on 02/25/2016. An analysis was performed on the returned lead portions and a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The returned 337mm section was received in a twisted configuration, suggesting some level generator manipulation occurred while it was implanted. During the visual analysis of the returned 45mm portion the quadfilar coil appeared to be broken approximately 45mm from the end of the cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. Two of the broken coil strands were found to have been mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type, with pitting on one. Another broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting and stress induced stress lines were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. During the visual analysis a portion of the lead assembly appeared to be twisted and compressed. Abraded openings were observed on the outer and inner silicone tubes, in this area. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

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« Reply #250 on: March 25, 2019, 12:39:03 AM »

Model Number 302-20
Event Date 01/05/2016
Event Type  Malfunction   
Event Description
A physician reported that during a generator replacement surgery, he observed that the previously implanted lead appeared to be kinked (bended and folded) where the lead and pin meet. At this location there was a small horizontal slit in the lead and fluid was seen inside the lead body. The surgeon believes that the fluid and slit were due to the observed kink. No high or low impedance or adverse events had been observed with the system prior to the generator replacement surgery; pre-surgical impedance was reported to be 1,875 ohms. The surgeon replaced the generator and connected the new generator to the lead. With the new generator the lead impedance remained within normal limits at 2,255 ohms. Although the system was exhibiting normal lead impedance the physician elected to replace the lead given the observation of compromised insulation and fluid within the lead. Review of available programming and diagnostic history revealed no anomalies and no abnormal lead impedance values. The explanted pulse generator and lead have not been received by the manufacturer to date.
 
Event Description
The explanted lead and pulse generator were returned to the manufacturer for product analysis. Analysis of the lead showed abraded openings on both the inner and outer silicone tubing. The positive coil was exposed in one of the areas of the abraded openings and showed smoothed surfaces due to wear. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No discontinuities were identified within the returned lead portion. There were no performance or any other type of adverse conditions found with the pulse generator. The battery, 2. 720 volts as measured during testing, shows an ifi=yes condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5399459
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« Reply #251 on: March 29, 2019, 07:41:23 AM »

Model Number 103
Event Date 12/10/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2016 it was reported that the patient felt a lump and tension in the neck and generator site. This was reported as beginning the day after the last appointment on (b)(6) 2015. It is believed that the device may have migrated which was causing the difficulty interrogating the patient previously. It was noted that the patient was able to be successfully interrogated at this visit. Diagnostics were noted to be within normal limits and ifi-no. The patient has been referred to the surgeon for consult. The patient underwent a prophylactic replacement on (b)(6) 2016. The pre-op diagnostics were within normal limits and ifi-no. The patient had complaints of pulling sensation and migration of generator. The lead was reported to be uncoiled and the generator only was replaced. During surgery it had appeared that the generator had dropped in the chest and it looked like the lead was coiled almost as if the patient had manipulated the device but it was stated the patient did not. It was confirmed that non-absorbable sutures were used to secure the previous generator. The reported lump that the patient felt was determined to be the coiled lead in the chest. The lead pulling sensation was thought to be due to the generator dropping in the chest (reason is not known as manipulation or trauma is not suspected) and due to the lead being coiled (also reason unknown). The explanted generator has not been received to date.

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« Reply #252 on: March 30, 2019, 01:46:48 AM »

Model Number 303-20
Device Problems Fluid Leak; Mechanical Problem; Low impedance
Event Date 06/08/2015
Event Type  Malfunction   
Event Description
Low impedance was observed in the patient's device programming data on (b)(6) 2015. Additional information was received from a nurse that the patient's device was temporarily disabled on (b)(6) 2015 due to mri and that the patient did not see the physician until (b)(6) 2015. Per the clinic note in (b)(6) 2015, the vns device was interrogated and low impedance was observed. The physician acknowledged that this might be due to a lead fracture and disabled the vns from 1. 5 ma to 0 ma to see if patient needs to continue vns therapy as he has not had any seizures in several years. Patient was again seen in (b)(6) 2016 and possible removal of the device was considered. No known surgical interventions have occurred to date.
 
Event Description
Device diagnostics showed a low impedance value in (b)(6) 2016 and the device was turned off. The patient had remained seizure free with the device turned off, and so the decision was made to remove the device. Patient underwent explant of the generator and lead. The explanted devices have not been received to date.
 
Event Description
The explanted lead and generator were received. Analysis performed on the generator shows that there were no additional performance or any other type of adverse conditions. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 078 volts, shows an ifi=no condition. A portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the bilumen tubing appeared to be twisted, in most areas. During the visual analysis the bilumen tubing appeared to be twisted and the (-) green electrode spot-weld and portion of ribbon appeared to be torn from the ribbon. Abraded openings were observed on the bilumen tubing and the tri-filar coils appeared to be exposed in these areas. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddling of device). The abraded openings found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing. What appeared to be white deposits were observed on the bilumen tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposits as containing silicon. With the exception of the abraded openings and exposed tri-filar coils, the condition of the returned lead portion is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5514040
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« Reply #253 on: March 30, 2019, 01:47:31 AM »

Model Number MODEL 250
Event Date 02/25/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the physician is having a problem with a tablet. The physician states there is a bent pin where the usb cable goes in which is causing the usb serial cable to not be able to communicate with the wand. The associated serial cable was discarded. The tablet has not been received for analysis to date.
 
Event Description
Tablet was received for analysis on 03/30/2016. Product analysis for the tablet was completed and approved on 04/20/2016. An analysis was performed on the returned tablet and no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications. Visual inspection identified no anomalies. No bent pins in the usb port were identified. Two known good serial cables were tested on the tablet during initial troubleshooting which did not work on the old system. The wand was also confirmed to be functioning properly. Therefore, it is unknown what may have caused the communication issues with the tablet port.

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« Reply #254 on: April 02, 2019, 12:11:44 AM »

Model Number 304-20
Device Problems Fracture; High impedance; Low impedance
Event Date 04/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician reported to an international distributor that low lead impedance had been observed in a patient's vns system at a device follow-up. X-rays were taken and provided to the manufacturer for review. The x-rays showed no obvious anomalies but did reveal a possible sharp bend in the lead just above the generator and a possible pin insertion issue. The entire lead body could not be evaluated based on the x-ray images submitted. Submitted diagnostic data shows three low impedance (<600 ohms) measurements on (b)(6) 2016 along with 7 normal impedance measurements on that same date. A decrease in impedance is observed in the data over the last seven months. No patient adverse events have been reported. The physician intends to monitor the patient's condition and continue normal patient following. No specific intervention is planned and no surgical interventions have occurred to date.
 
Event Description
Follow-up on this event was provided indicating that the patient's impedance values were fluctuating. The patient had low impedance values that fluctuated to high impedance on (b)(6) 2016. Then, on (b)(6) 2016 the impedance values were all within normal limits. Then, the patient was visited on (b)(6) 2016 and the impedance values were high on multiple system diagnostic tests. The system diagnostic test on (b)(6) 2016 was also high. Then, the patient was seen on (b)(6) 2017 and the impedance was within normal limits. A new set of x-rays was provided for review and there was no indication of a sharp angle on this x-ray and the lead pin did not appear fully inserted into the connector block. No know surgical intervention has occurred to date.
 
Event Description
The patient was seen for a clinic visit on (b)(6) 2018, and high lead impedance was observed on her device. The distributor noted that the patient's device had previously shown both high and low lead impedance, but the impedance values had recently been within the normal range. Diagnostics performed at the clinic visit indicated an output current of only 0. 50 ma was being delivered, although the generator was programmed to 1. 5 ma. The distributor planned to send x-rays to the manufacturer for review. The x-rays were received by the manufacturer but have not been reviewed to date. The full programming history was reviewed for the patient's generator. Fluctuating impedance values were observed throughout a significant portion of the programming history, including the aforementioned low and high impedance, along with several internal impedance changes not observed in previous diagnostic tests. Low impedance was internally detected between multiple interrogations when impedance appeared to be normal in system diagnostic testing, indicating several quick fluctuations in impedance value. On (b)(6) 2017 impedance values were within the normal limits and remained so through multiple clinic visits until (b)(6) 2018; however, the high impedance was internally detected three days prior. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The x-ray images were reviewed by the manufacturer. Due to the angle of the generator in the image, lead pin insertion into the generator could not be assessed. The filter feedthrough wires appeared intact, and the lead wire appeared intact at the lead pins. The lead was observed in the neck and chest. Due to the exclusion of the patient¿s upper neck from the provided images, the presence of strain relief could not be assessed in its entirety; however, a strain relief bend did appear to be present, and a strain relief loop appeared to be complete. Two tie-downs secured the lead at the strain relief bend, and one tie-down secured the lead at the strain relief loop. A portion of the lead appeared to be routed behind the generator. No gross fractures or lead discontinuities were observed in the provided images as visibility of the lead was lost near the collarbone. 3d-ct images were also included with the provided x-ray images. The presence and completeness of the lead strain relief was confirmed in the 3d-ct images. The portion of the lead routed behind the generator was also visible in the images, and a gross fracture was visualized in the portion of the lead that was not visible in the x-ray image. The thickness of the lead was minimal at the fracture location compared to the remainder of the lead body, signaling the potential for a short circuit condition to have existed. No additional relevant information has been received to date. No surgical intervention has occurred to date.

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« Reply #255 on: April 02, 2019, 12:12:57 AM »

Model Number 303-20
Event Date 04/25/2016
Event Type  Malfunction   
Event Description
It was reported that during generator replacement the lead showed uninsulated spot just after the connection to the generator. Furthermore, the lead was bent 180 degrees at this spot. The lead was disconnected from the old generator with some difficulties. Then, it was plugged in the new generator. The lead impedance at this time was 1400 ohms. Generator was placed into the pocket, and the wound was closed. System diagnostics was performed again and it showed impedance below 600 ohms. New generator has been left in place. Follow up indicated that no explanted generator return is possible as this was discarded after the replacement surgery. It was also reported that the physician did not suspect a lead manipulation. The device manufacturing records were reviewed. The review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Further follow up with nurse indicated that the patient underwent a lead and generator replacement; during the lead replacement on (b)(6) 2016 no hex screwdriver was available in the or to disconnect the lead from the generator. That was the reason of the replacement of the generator as well. The facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

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« Reply #256 on: April 03, 2019, 01:03:14 AM »

Model Number 304-30
Event Date 05/07/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient had high impedance at about 9,000 ohms. The patient also reported feeling discomfort in her neck periodically with stimulation. The patient's device was noted to have been left on. There were no reported causes for the impedance issues or when the last known diagnostics were performed at the time of the call. The patient was being referred for full replacement surgery. The generator was going to be replaced due to the patient's desire for the newer model. No surgical intervention has occurred. No further relevant information has been received to date.
 
Event Description
The explanted generator had product analysis completed. Product analysis of the generator confirmed proper generator functionality. The generator confirmed its ability to provide appropriate programmed output currents. Additionally, a comprehensive automated electrical evaluation showed that the generator performed according to all functional specifications. There were no performance or any other type of adverse condition found with the generator.
 
Event Description
The patient had full replacement surgery on (b)(6) 2016. The explanted lead and generator were returned to the manufacturer for analysis. A section of the lead assembly was returned for analysis in one piece. Setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Also, the connector ring had scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Abrasions were noted on the connector boot and on the outer silicone tubing at multiple locations. The outer silicone tubing had a compressed appearance at multiple locations. A suspected coil break was identified at the end of the negative coil. The negative coil also had a discolored appearance in the vicinity of the broken end. Scanning electron microscopy images of the positive coil showed that pitting or electro-etching conditions had occurred at the break location. The returned lead assembly had kinks in at least one of the coils in two locations. The lead assembly had dried remnants of what appeared to have once been body fluids in the small o-ring boot location inside the inner silicone tubing. Scanning electron microscopy of the positive coil showed that pitting or electro-etching conditions had occurred at the coil end, showing evidence suggestive of a stress-induced fracture. No further relevant information has been received to date.

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« Reply #257 on: April 03, 2019, 01:04:10 AM »

Model Number 303-20
Event Date 04/01/2016
Event Type  Malfunction   
Event Description
Clinic notes were received on 04/07/2016 for patient referral for surgery. The notes state that the last visit her settings were adjusted to 1. 25ma/30 sec. The patient came to the office today with a one week history of feeling electrical shocks in her neck. Interrogation of the device confirmed a probable lead fracture with immediate warning of high impedance in excess of 5000 ohms. She states that she is unsure how this happened although she reports having seizures in her sleep. The device was turned off. The patient had a full replacement on (b)(6) 2016. The explanted devices have not been received to date.
 
Event Description
The generator and lead were received for analysis on 06/02/2016. Product analysis for the lead was completed and approved on 06/23/2016. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the bilumen tubing appeared to be twisted, in several areas and the end appeared to be twisted / abraded open / torn. During the visual analysis the connector pin tri-filar coil appeared to be broken in two areas. Scanning electron microscopy was performed on the connector pin tri-filar coil break as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage. The area on another broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the last broken coil strand was identified as having what appeared to be evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and residual material. Scanning electron microscopy was performed on the connector ring tri-filar coil break and identified the area on one of the broken coil strands as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage on both and pitting on one of the broken coil strands. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings / torn area found on the bilumen tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the bilumen tubing. With the exception of the observed discontinuities and abraded opening the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Product analysis for the generator was completed and approved on 06/27/2016. The returned decoder shows that the ¿diagvinitialprechange¿ value is 4523 ohms while the ¿diagvinitialpostchange¿ value is 13568 ohms, and the time of change detection (b)(6) 2016 (explant (b)(6) 2016). Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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.

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« Reply #258 on: April 03, 2019, 01:04:52 AM »

Model Number 302-20
Event Date 01/30/2016
Event Type  Malfunction   
Event Description
It was reported that the patient铠lead experienced high impedance. He was scheduled for a full revision surgery. The patient also reported painful stimulation in the neck, and the device was disabled in relation to the high lead impedance. Surgery has not been reported to occur to date. Additional pertinent information has not been received to date.
 
Event Description
The patient's vns system was fully replaced on (b)(6) 2016. The impedance value of the replacement system was within normal limits. The explanting facility does not return explanted devices, so product return of the explanted generator or lead is not expected. No additional pertinent information has been received to date.
 
Event Description
The explanted generator and lead portion were received and underwent product analysis. It was noted that the lead was still inserted into the generator when it was received. A continuity check was performed on the lead and setscrew of the generator which verified proper contact between the lead pin and setscrew. Analysis on the lead found a kink in the lead coils however no discontinuities were identified in the returned portion of the lead. It was noted the portion of the lead with the electrode segment was not returned. Therefore it could not be evaluated and its role in the reported high impedance could not be determined. During analysis on the generator various impedance loads were attached to the generator and the subsequent diagnostic tests resulted in the accurate resistance measurements in all instances. The generator found that it performed to functional specification. The internal data of the generator was reviewed and noted the last >25% change in impedance occurred on (b)(6) 2016 when the prechange value was 2460 ohms and the postchange value was 11807 ohms.

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« Reply #259 on: April 03, 2019, 01:05:42 AM »

Model Number 304-20
Event Date 04/12/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during a routine office visit the physician found high impedance. Diagnostics were run on this patient 4 months earlier and high impedance was not seen during that visit. X-rays were performed and no gross fractures were observed. No trauma or contributory factors were reported to have caused the high impedance. The patient's generator was programmed off. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The patient underwent a generator and lead replacement. During surgery, the surgeon observed a small kink in the lead which caused a small hole in the lead which allowed fluid to enter. The explanted lead and generator have not been received to date.
 
Event Description
It was reported that the explanted lead and generator will not be returned. Therefore product analysis will not be performed.

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« Reply #260 on: April 04, 2019, 12:44:17 AM »

Model Number 302-20
Event Date 05/19/2016
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2016 that the patient's vns system registered high lead impedance. X-ray images of the patient's vns system were received by the manufacturer and subsequently reviewed. There was one image provided that could be reviewed. The generator was placed normally per labeling. The connector pin of the lead could be confirmed to be fully inserted inside the connector block. The feed thru wires appeared intact. The location of the electrodes appeared to be placed per labeling. A small portion of the lead was behind the generator, making the lead difficult to assess in this area. There were two places where there were apparent sharp angles in the lead. There were no apparent gross fractures of the lead that could be seen in the images given. The wires at the lead connector pin appeared to be intact. From the x-rays received, the cause for the reported high impedance could not be determined. Although there were apparent sharp angles in the lead, this could not be confirmed to be indicative of device damage. There was nothing seen that would indicate there was damage to the generator or lead. However, the presence of a micro-fracture in the lead cannot be ruled out. Surgical intervention has not been reported to have occurred to date. No additional pertinent information has been received to date.
 
Event Description
The patient vns system was fully replaced in surgery on (b)(6) 2016. The explanted products were received by the manufacturer on 10/14/2016 and are undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed for the returned generator. Visual examination identified only explant related observations. No surface abnormalities were noted on this device. The device performed according to functional specifications. The can was inadvertently opened. Measurements of the device battery voltage and current drain were as expected, confirming that the battery was not at an eri condition. No internal visual anomalies were identified. No abnormal performance or any other type of adverse condition was found. Product analysis was performed on the returned lead portion. Note that the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead. The connector pin quadfilar coil appeared to be broken in two places, approximately 231mm and 255mm from the end of the connector boot. Scanning electron microscopy (sem) was performed and identified the areas as being mechanically damaged and/or having extensive pitting, which prevented identification of the coil fracture type(s). The connector ring quadfilar coil appeared to be broken in two places, approximately 244mm and 255mm from the end of the connector boot. Sem was performed on the connector ring quadfilar coil break at 244mm and identified the area as being mechanically damaged and pitted, which prevented identification of the coil fracture type. Sem was performed on the connector ring quadfilar coil break at 255mm and identified the area on three of the broken coil strands as having evidence of a stress-induced fracture. The fourth coil showed mechanical damage and pitting, which prevented identification of the coil fracture type. Abraded openings were located on the outer and inner silicone tubes, and most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Continuity checks of the returned lead portion were performed, and no other discontinuities were identified. With the exception of the observed discontinuities and abraded openings the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.

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« Reply #261 on: April 07, 2019, 01:50:10 AM »

Model Number 300-30
Device Problem Mechanical Problem
Event Date 02/18/2019
Event Type  Malfunction   
Event Description
It was reported that during a patient's battery replacement surgery, the surgeon noticed that the lead had a sharp 90 degree bend in it and that the insulation around the wires had been compromised with a slight tear; however, the wires looked perfectly intact. The old generator was replaced with the new generator and diagnostics were performed with the generator out of the pocket, the results came back ok. The surgeon then decided to use the medtronic boots and anchors accessory kit (355024) to repair the insulation tear. The surgeon proceeded to use that product to repair the insulation. The surgeon did not replace the lead. After the insulation was replaced, diagnostics were run with generator out of the pocket and impedance was good. No additional or relevant information has been received to date.

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« Reply #262 on: April 09, 2019, 12:24:16 AM »

Model Number 302-20
Event Date 05/12/2016
Event Type  Malfunction   
Event Description
A provider called to report that a vns patient's system was exhibiting high lead impedance. The provider indicated that the generator was last replaced in 2013 and at the last device check in (b)(6) 2016 the lead impedance was within normal limits at that time. A review of available programming and diagnostic history revealed no anomalies through (b)(6) 2015. No causal factors that might have contributed to the high lead impedance were known. The provider elected to disable the device output and refer the patient for revision surgery. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
X-rays were taken after the high impedance condition was observed but no obvious anomalies were identified by the providers. The patient underwent full system revision on (b)(6) 2016. Pre-operative diagnostics indicated ok communication, low output current, high lead impedance, >=10,000 ohms, ifi - no. No abnormalities were seen in the main body of the lead however the surgeon identified an area near the bifurcation that appears to be kinked/fractured. The lead was cut at that point and a new lead was implanted with the electrodes being placed below the original electrodes. The generator was replaced prophylactically. The newly implanted system was tested and all measurements were within normal limits. The explanted products were explanted per hospital policy.

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« Reply #263 on: April 13, 2019, 03:29:35 AM »

Model Number 304-20
Event Date 05/01/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient's device showed low impedance at 600 ohms. No injuries, falls, or trauma were reported. It was stated by the patient's mother that they get efficacy from the magnet. The patient has been referred for full revision. Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective. An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation. " the device had been programmed off on (b)(6) 2016. Lead and generator revision surgery occurred on (b)(6) 2016. A lead break was visualized approximately one-third of the distance from the generator. The explanted devices have not been received to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.
 
Event Description
The explanted devices were received for analysis on 10/05/2016. Analysis was performed on the returned lead portion 10/24/2016. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes. The coils were bare and exposed in the areas of the abraded openings. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium. With the exception of the twisted appearance and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis was completed for the returned generator 10/27/2016. The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016. The device was explanted later on (b)(6) 2016. Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. 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. The battery measured 3. 055 volts and shows an intensified follow-up indicator was not set. 18. 519% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies.

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« Reply #264 on: April 13, 2019, 03:30:16 AM »

Model Number 303-20
Event Date 07/28/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that low impedance was observed on vns patient's system implanted on (b)(6) 2015. The impedance was already found to be low some times before, but when the patient's device was checked in (b)(6) 2016, 3 system diagnostic tests were performed which showed impedance values of 600 ohms, 3000 ohms and again less than 600 ohms. X-ray was taken and sent to the manufacturer for review. The generator appears on the x-ray to be placed in upper chest in normal arrangement. The filter feed-through wires appears to be intact. The pin connector appears to be fully inserted. The electrodes appeared to be placed in normal arrangement. It is unable to assess the presence of the strain-relief bend and loop and if they were placed as specified by labeling. One tie-down is visible to secure the implanted lead. A portion of lead behind the generator could not be assessed. A clear lead discontinuity is visible, near the clavicle. A sharp angle is visible in the chest near the generator block connection and in that area, the lead appears to be twiddled. Based on the x-ray image, the cause for low impedance could be a short circuit in the lead part that appears to be twiddled. Further information was received from the nurse, indicating that no loss of efficacy yet but the patient recently could not perceive stimulation in magnet or normal mode. It was reported that no trauma was noted. The nurse indicated that it's unlikely that twiddling occurred as the generator is fairly deep and under a large breast. It was reported that the patient suffers from anxiety. Review of manufacturing records confirmed that both, the generator and the lead, passed all functional tests prior to distribution. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An implant card was received which indicated that the patient underwent lead revision surgery. The explanted lead has not been received to date.

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« Reply #265 on: April 14, 2019, 01:05:45 AM »

Model Number MODEL 250
Event Date 07/21/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The tablet was reported broken at the usb port, which was visualized. The prongs on the usb port of the tablet were bent to the point that the serial cable had to held in an inconvenient position in order for it to work. No issues were seen with the physician's serial cable or wand. Additional information was received that the issue was first observed when a company representative visited the office on (b)(6) 2016. The handling of the device was not suspected to have caused the issue. The wand and serial cable was tested with the company representative's programming system to determine that there was no issue with their function. The tablet has not been received to date.
 
Event Description
The tablet was received on 8/15/2016. An analysis was performed on the returned tablet and the reported allegation of mechanical problem with usb cable to tablet connection was verified. During the analysis it was identified that the usb port was damaged. As a result, the tablet was unable to establish communication. No further anomalies were identified.

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« Reply #266 on: April 14, 2019, 01:06:25 AM »

Model Number 302-20
Event Date 02/08/2016
Event Type  Malfunction   
Event Description
It was reported through clinic notes that a replacement surgery was planned as the patient was at eos = yes (end of service) and due to the report of generator migration. It was explained that the patient noted the generator was dislodged and able to move relatively freely. A battery life calculation was performed which confirmed the device was at eos. It was reported the patient had surgery on (b)(6) 2016 and the surgeon noted the lead was found in a ball when the incision was opened. It looked as if the patient was twisting her generator in the pocked over time. A new generator was placed on the lead and high impedance was found. This high impedance was not previously found since the explanted generator was at eos and could no longer communicate. Due to the high impedance observed, the lead was also replaced. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported the lead was cut into many pieces and intertwined with tissue and would not be returned to the manufacturer for analysis as it was discarded after surgery. The generator was noted it would be returned; however, it has not been received to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanted generator was returned for analysis. Pa (product analysis) for the returned generator was approved and the end of service condition was confirmed in the (b)(4) lab as the battery voltage measurement determined the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation and the electrical test results. The reported failure to program was determined to be caused by the normal battery depletion. The report of the generator migration was beyond the scope of the (b)(4) activities. The device performed according to functional specifications and no abnormal performance or any other type of adverse condition was found.

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« Reply #267 on: April 16, 2019, 12:23:08 AM »

Model Number 304-20
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Initial reporter phone#: (b)(6).
 
Event Description
High impedance was identified on a system diagnostic test on (b)(6) 2016. The generator was programmed off after the high impedance was identified. The patient underwent full replacement on (b)(6) 2016. X-rays were provided to the manufacturer and reviewed. The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact. The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling. No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin. Sharp angles were observed in the portion of the lead near the generator. A gross fracture was identified in the lead. The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.
 
Event Description
The explanted lead and generator were both returned to have product analysis performed. The lead was returned in two portions. During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed. The connector boot also appeared detached from the connector ring surface. Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil's surface. Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type. During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture. Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting. Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing. Dried remnants of what appeared to be body fluids was found within the inner tubing. The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016. Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms. The battery voltage was found at 2. 956v and approximately 45% of the charge had been consumed. The generator was found as conforming to all functional specifications.
 
Manufacturer Narrative
Supplemental report #1 inadvertently did not update the event date per the new information identified.

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« Reply #268 on: April 16, 2019, 12:24:04 AM »

Model Number 302-20
Event Date 08/25/2016
Event Type  Malfunction   
Event Description
During a prophylactic generator replacement surgery, the surgeon saw the lead was tied in a knot. When he straightened the lead out, he noticed the insulation of the lead was degraded. Impedance on the previous device was less than 600ohms. Therefore the surgeon performed a full revision surgery. The explanted devices were received on 09/20/2016. Analysis is underway but has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported "mechanical problem / abraded insulation" (lead section) allegation was verified. The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis the outer silicone tubing appeared to be compressed, twisted with abraded openings, in several areas. During the visual analysis, multiple lead portions appeared to be melted. What appeared to be spatter and pitting was found on the surface of the quadfilar coil strands. Based on the obvious signs of melting on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded openings and melted appearance found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the melted / torn ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 813 volts, shows an ifi=no condition. 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=5966266
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« Reply #269 on: April 17, 2019, 06:42:39 AM »

Model Number 304-20
Device Problems Corroded ; Fracture
Event Date 08/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that low impedance was detected. No trauma or manipulation of the device was reported. The device was disabled. No surgical intervention has been performed to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's low impedance was a result of the patient twiddling his lead, which knotted and broke the lead. The patient's lead was replaced due to the low impedance. Suspect product was received. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned lead. The majority of the lead body was returned but not the electrode array. Visual analysis noted several abrasions along the outer tubing as well tearing on the portion of the lead near the pin. The lead body was twisted near the lead pin and the lead appeared compressed in several locations. Setscrew marks on the connector pin indicated that there was a good mechanical and electrical connection between the lead and generator at one time. Two coil breaks were noted at the end of lead body. Microscopic analysis identified pitting on the fractured end of the lead. Both the positive and negative lead fractures were attributed to mechanical stress. The appearance fracture at the negative lead coil suggested that it fractured due to rotational mechanical stress in at least two of the three strands. Low impedance was not replicated during product analysis. No other anomalies were found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5949291
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