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Author Topic: Bent/Kinked/Twisted  (Read 29416 times)
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dennis100
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« Reply #300 on: June 07, 2019, 04:59:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was referred a generator site revision due to pain at the generator site. The patient had severe weight loss and it was recommended that the patient would replace their generator with a smaller generator. The generator was replaced. Per the physician¿s office, the patient¿s weight loss was due to bariatric surgery a year ago and unrelated to vns. The patient¿s pain was related to the migration, as the device would twist and move in the loose skin. The replacement was for both patient comfort and to preclude serious injury. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591645
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dennis100
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« Reply #301 on: June 08, 2019, 05:03:12 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/25/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance and the device was disabled. It was noted that the physician reviewed x-rays and was unable to determine whether or not a clear wire break was present. It was noted that the patient reported no longer feeling stimulation resulting in the impedance being checked and found to be high. X-rays were received and reviewed for the patient. The connector pin can be seen coming through the second connector. The filter feedthru were confirmed to be intact. The lead wires appeared intact at the connector pins. No gross discontinuities were identified in the visible portion of the lead. A sharp angle was noted at the top of what appears to be the strain relief loop. It should be noted that the sharp angle may be a result of the angle of the image. The cause of the patient¿s high impedance could not be determined based on the images provided. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Further information was received that the patient reported no trauma or manipulation to the area. It was noted that suddenly the stimulation was no longer perceived. No further physician¿s assessment of the high impedance was provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8624293
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dennis100
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« Reply #302 on: June 08, 2019, 05:03:57 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/23/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance upon interrogation. The battery was noted to be at ifi (intensified follow-up indicator). X-rays were received and reviewed for the patient. The generator was located in the patient¿s upper left chest. The connector pin can be seen coming through the second connector block. The filter feedthru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. A strain relief bend, strain relief loop, and one tie-down were present. The lead wires appeared intact at the connector pins. No sharp gross discontinuities were identified in the visible portion of the lead. A sharp angle was observed in the main body of the lead. Based on the x-rays received, the cause for the high impedance could not be determined. The presence of a fracture or micro-fracture in the lead cannot be ruled out. It should be noted that due to the scale of the images and the limited images provided, the complete length of the lead from neck to generator could not be assessed as the image was not provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8616027
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dennis100
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« Reply #303 on: June 09, 2019, 12:46:31 AM »

Model Number 304-20
Device Problem Fracture
Event Date 04/30/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen on a patient's device. It was also reported that all of the patient's output currents were programmed off. Additional information was received that per the neurosurgeon, it was assumed that it was in a dance class that she felt something had happened on the generator. Photos of the patient's ap and lateral neck and chest x-rays were also received and reviewed and revealed that the cause of the high impedance is likely lead fracture, as it does appear that the leads are coiled which can lead to a lead discontinuity as well as a possibly discontinuity visualized. Device history records were reviewed on and the device passed all functional specifications and quality tests and were sterilized prior to distribution. Though surgery is likely, no surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8633801
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dennis100
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« Reply #304 on: June 10, 2019, 12:29:14 AM »

Model Number 303-20
Device Problem Mechanical Problem
Event Date 09/15/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient has had a recent change in behavior, becoming very agitated and feels like she is being shocked. Follow-up from the company representative who spoke to the physician provided that he thought it was due to the last increase in dose. He also said that the patient is very thin and you can feel the lead which he then said it might have felt like it was twisted but not sure. He referred the patient to the surgeon for a check of the lead. All diagnostics checked out fine. Further follow-up from the provider indicated that they found a wire that appeared to be kinked. The device was functioning with no errors and impedance was within normal limits. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7019422
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dennis100
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« Reply #305 on: June 11, 2019, 12:34:00 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 09/22/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to an intensified follow-up indicator, or ifi, condition. During the replacement surgery, it was found that the lead was in a knotted state wrapped around the lead connector pin. It was also reported that the insulation was opened was compromised. Images of the lead condition were reviewed by the manufacturer. There appeared to be an opening in the lead insulation and fluid in the lead. The patient underwent a full vns replacement surgery as a result. Follow up with the company representative revealed that the patient was not a known twiddler and that there was no known trauma or patient manipulation that could have contributed to the condition of the lead. It was reported that the vns was still secured via suture when the patient underwent surgery. The explanted generator and lead have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6957201
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dennis100
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« Reply #306 on: June 12, 2019, 02:30:03 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 08/31/2017
Event Type  Malfunction   
Event Description
It was reported that the surgeon opened a lead package for a new patient implant and was concerned about the way the lead coils looked. The surgeon thought something was wrong with the lead coil and felt the lead coils were fractured in the package and thus did not use it. A different lead was successfully used for the surgery. A review of device history records for the lead shows that no unresolved non-conformances were found. Analysis is underway but has not been completed to date.
 
Event Description
The lead underwent product analysis and a kink in at least one of the lead coils was noted past the electrode bifurcation. The anchor tether was also visualized to be torn into two pieces and the suture partially detached from the helix. Suspected tool imprints were identified on the anchor tether silicone helix near the tear. Though difficult to state conclusively based on the inspection results it is believed that the most likely root cause for the anchor tether suture detachment and the observed damaged to the anchor tether helix was manipulation of the lead not consistent with our labeling. Other than the above mentioned observations and typical implant or explant related observations, no other anomalies were identified in the returned lead assembly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6922020
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dennis100
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« Reply #307 on: June 15, 2019, 11:10:01 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Under-Sensing ; Low impedance
Event Date 06/05/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the generator was not detecting heart rate. The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance. Low impedance may interfere with heartbeat detection. The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1). However, approximately four months later, the generator continued to have difficulty detecting heart rate. Low impedance was detected intermittently through system diagnostics. The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back. ' the patient said that she still felt normal and magnet mode stimulation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead and generator had been replaced due to low impedance. During explant a kink in the lead was observed that had caused the tubing to rupture. Reportedly there was nothing unusual about the placement of the lead on the nerve. The explanted lead and generator were received, but product analysis on the devices have not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. The generator was able to sense heart-rate normally. No anomalies were identified with the generator. Product analysis was completed on the returned lead. The lead was received in two pieces and the electrodes were not received. Two (2) abraded openings in just outer tubing were identified. One abraded opening in the inner and outer tubing was observed. At this opening, a lead break in the positive coil was found and pitting conditions were observed at the location. Dried body fluids were identified in the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portion. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7011776
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dennis100
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« Reply #308 on: Today at 12:27:54 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. Pre-operative diagnostics did not show high lead impedance but imaging did show the nerve was being pulled on by the lead. Imaging showed the nerve was almost at a 90 degree angle due to lead pulling on nerve. The explanted devices were discarded in surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7134281
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