Pages: 1 ... 5 6 [7]  All   Go Down
Print
Author Topic: Poor X-Ray Image  (Read 20277 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 53859


« Reply #180 on: November 09, 2018, 01:34:42 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/03/2018
Event Type  Malfunction   
Event Description
Patient reported experiencing painful stimulation and had taped a magnet over the device overnight to avoid this pain. Upon interrogation, high impedance was observed. Diagnostics were performed and the generator was not near end of service. X-rays were reviewed. The generator placement appeared to be normal in the left axillary chest area. A small portion of the lead pin is visible past the connector block and the feed-through wires appear to be intact. However, lead wire connectivity at the connector pin could not be assessed due to the quality and angle of the x-ray images. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Based on the images provided, there is no obvious cause for the reported events. Patient was referred for surgery, but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8010867
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 53859


« Reply #181 on: November 14, 2018, 07:45:37 AM »

Model Number 302-20
Event Date 01/10/2013
Event Type  Malfunction   
Event Description
The patient's generator is not at expected end of battery life per calculations performed. At this time the patient's vns programming physician does not intend to disable their device till surgery is performed.

Event Description
No surgery date is set at this time. Good faith attempts have been made and no further information attained. X-rays were received for review. The electrodes are visualized in a normal orientation. It was unable to be accessed based on the view if there was a full bend present distal to the anchor tether location. There was an area of suspect in this location and it could not be fully visualized. There did not appear to be a loop but the lead body was routed up and secured by one tie down. No other tie downs were present. The lead body then routed towards the generator. Strain relief did appear adequate for movement but was not per labeling. The lead should be formed into a large subcutaneous loop above the sternocleidomastoid muscle and loosely attached to the fascia with a tie-down before routing the lead over the clavicle. The strain relief loop should be large enough to provide several inches/centimeters of lead extension when the neck is turned to its maximum stretched positions. The lead body was not placed per labeling as there appeared to not be a bend secured with a tie down lateral to the anchor tether, nor was there a loop secured with a tie down. The lead routed to the generator and no lead breaks were seen in this area. There was some lead behind the generator that could not be viewed. The filter feedthru wires could not be fully viewed based on the clarity of the picture. The pin being fully inserted could not be viewed based on the angle of the header of the generator. Therefore full insertion could not be confirmed. The lead body did appear intact at the connector pin. The cause of the high lead impedance is unknown. The pin being fully inserted cannot be confirmed. There was an area of suspicion near the anchor tether that could not be fully visualized. Unknown if a sharp angle is present in that location based on the clarity of the picture. No gross lead breaks were seen. In addition, the high impedance may also be due to anomalies in the lead under the generator that cannot be assessed.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities noted. Omitted x-ray review on initial report. X-rays received same date report sent.

Event Description
It was reported that the patient underwent prophylactic generator replacement surgery on (b)(6) 2013. It was reported that high impedance was seen with the new generator and existing lead, but that the lead was still not replaced. It was reported that the patient will undergo another surgery soon to replace the lead. It was reported that the new generator was left programmed off.

Event Description
Additional information was received that the patient will have full revision surgery. A prophylactic generator replacement and likely lead replacement. Surgery will not be performed until the patient can get full government funding.

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

Event Description
Our distributor in (b)(4) was contacted by a vns treating physician reporting that they had a patient with high lead impedance. No fall or injury was reported in relation to their high lead impedance. X-rays will be sent to the manufacture for review. No surgery date has been set for the patient at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2957101
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 53859


« Reply #182 on: December 08, 2018, 01:25:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury   
Event Description
The physician's assistant (pa) reported that the patient presented with left neck pain so pain injections were attempted, which did not resolve the issue. The patient was then sent for x-rays. Per the x-rays the pa believes the generator migrated due to potential chest compressions at an er visit and the er visit was unrelated to vns. It is not "know" when the patient was in the er. The pa believed the migration caused the neck pain due to the lead tightening. The patient was referred for surgery to suture the generator higher. The pa stated the diagnostics were normal. X-ray images were assessed by the manufacturer as well. Based on the images provided, the generator was placed normally in the left chest. Due to the poor quality of the image, nothing further could be assessed concerning the generator. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. Due to the poor quality of the image, nothing further could be assessed concerning the lead. Based on the images provided, there is no obvious cause for the reported pain and generator migration. Additional information from the pa reported that the surgery will be for patient comfort and to preclude serious injury. The settings were initially turned off after the pain to see if there would be a reduction in pain, which there was not. The settings were later turned back on to lower settings. The physician later decided to replace the generator because it was already 2 years old instead of just performing a revision. No additional relevant information has been received to date.

Manufacturer Narrative
"device evaluated by manufacturer": device evaluation is not necessary as the reported events are not related to device functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8034826
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 53859


« Reply #183 on: December 15, 2018, 01:13:24 AM »

Model Number 300-20
Event Date 10/02/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that device diagnostics resulted in high impedance (9986 ohms). The physician sent the patient for x-rays. It was reported that the device was programmed off. The x-rays were received by manufacturer for review. The x-rays were of poor quality and could only assess a small portion of the lead wire. Based on the poor quality, a lead discontinuity cannot be ruled out. The patient underwent generator and lead replacement surgery. The explanted devices have not yet been received for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3440738
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 53859


« Reply #184 on: Today at 11:58:18 AM »

Model Number 300-20
Event Date 04/18/2005
Event Type  Malfunction   
Event Description
Through the manufacturer¿s periodic programming history review, it was found that high impedance was observed on system diagnostics performed on (b)(4) 2005. Follow up with the physician found that the patient had a full vns generator and lead replacement on (b)(6) 2013 due to end of service. Before the surgery, a system diagnostic test was run which indicated high lead impedance. There was no information available on if patient manipulation or trauma occurred which may have caused or contributed to the event. Although the device indicated high impedance, the patient did not show any side effects. When the patient visited the facility a few years ago, the vns output current was at 1. 0 ma. The patient was set to the same output current on the day of surgery, per the report. Pre- and post-surgery chest x-rays dated (b)(6) 2013 and (b)(6) 2013, respectively, were received and reviewed by the manufacturer. The generator was seen in the left chest. It appears that the lead pin(s) is fully inserted past the connector block in both the pre- and post-surgery images. Filter feedthru wires and the lead wires at the location of the connector pins appear to be intact. It appears that a portion of the lead is located behind the generator in both sets of x-ray images and therefore could not be assessed. Neck x-rays were not provided, so the electrode placement and strain relief placement could not be assessed. Based on the provided images, strain relief cannot be assessed. Two tie-downs are visible to be securing a strain relief bend in the pre-surgery x-ray. There did not appear to be any gross lead discontinuities or sharp angles in the lead portion that was able to be visualized. However, there are areas present in the chest area where image quality and contrast are poor, so continuity of the lead wire cannot be assessed. Additionally, continuity of the lead wires in the portions not visualized cannot be assessed with the provided images. Based on the x-ray images provided, the cause of the high impedance prior to replacement surgery cannot be determined. A portion of the lead was unable to be visualized in the chest, and the presence of a micro-fracture in the lead could be ruled out. The explanted generator and lead are not available for return.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. X-rays were reviewed by the manufacturer; no gross lead discontinuities were visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406887
Logged
Pages: 1 ... 5 6 [7]  All   Go Up
Print
Jump to: