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dennis100
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« on: March 23, 2012, 08:32:38 AM »

Model Number 302-30
Event Date 07/28/2009
Event Type Malfunction
Event Description
It was reported that a patient experienced pain and would grab the electrode and generator site every time the device activated stimulation. Further information was received from the medical professional stating that the patient's dc dc code dropped from 2 to 0 on system diagnostics. Additionally, the patient experienced an increase in seizures below pre-vns baseline which have not resolved by an increase in settings like they have done in the past. Based on clinical symptoms and the diagnostic history of the patient's device, the issue is possibly related to a short-circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1491972
« Last Edit: November 23, 2015, 12:07:54 PM by dennis100 » Logged
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« Reply #1 on: March 23, 2012, 08:32:57 AM »

Model Number 302-20
Event Date 05/01/2004
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt was experiencing events of painful stimulation with neck rotation. Follow up with the pt's treating vns therapy physician revealed that a decrease in the pt's therapy settings had not resolved the issue through the symptoms had improved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492068
« Last Edit: November 23, 2015, 02:31:44 AM by dennis100 » Logged
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« Reply #2 on: March 23, 2012, 08:33:20 AM »

Model Number 300-20
Event Date 11/16/2007
Event Type Malfunction
Event Description
During review of diagnostic history, this patient was identified to have an impedance value at the date of generator replacement surgery of 583 ohms. This is vastly lower than expected and suggests that this patient may have a short-circuit condition within the lead. Follow-up with the physician reveals that the patient has experienced an increase in seizures and does not feel stimulation. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492069
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dennis100
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« Reply #3 on: March 23, 2012, 08:34:01 AM »

Model Number 302-20
Event Date 05/01/2004
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported to manufacturer by the vns patient that the stimulation of the device did not feel as strong as it had previously, and that she had a recent increase in seizure activity as well as tooth pain. The patient further explained that she was involved in a physical altercation where she had been attacked and injured. The patient had been to see her neurologist following the incident, however, the altercation and subsequent adverse events that followed were not mentioned to the physician.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492071
« Last Edit: November 23, 2015, 02:32:42 AM by dennis100 » Logged
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« Reply #4 on: March 23, 2012, 08:34:20 AM »

Model Number 302-20
Event Date 07/01/2009
Event Type Malfunction
Event Description
Initial reporter indicated to a manufacturing consultant that their pt was having an increase in their seizures over their pre vns seizure rate and their dcdc code on their systems test had gone from a dcdc 2 to dcdc 0. The pt has not had any fall or injury preceding the dcdc 0. At this time unk cause of the pt's increase in seizures is related to the pt's dcdc 0. The pt's medications were titrated and the pt will be scheduled for a prophylactic generator replacement before it reaches end of battery life. The lead will be evaluated in the or for a possible short circuit condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1493827
« Last Edit: November 23, 2015, 02:33:04 AM by dennis100 » Logged
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« Reply #5 on: March 23, 2012, 08:34:47 AM »

Model Number 300-20
Event Date 07/13/2004
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that vns patient's seizure duration has increased. It is unknown if interventions were taken for this event. The patient's neurologist determined that the event was related to an "oil" the patient was given for constipation, therefore, unrelated to vns therapy. If present, an intermittent short-circuit could have potentially contributed to the patient's increased seizure duration event

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492059
« Last Edit: November 23, 2015, 02:33:36 AM by dennis100 » Logged
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« Reply #6 on: March 23, 2012, 08:35:38 AM »

Model Number 300-20
Event Date 01/25/2005
Event Type Malfunction
Manufacturer Narrative
Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusion : device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns patient experienced erratic stimulation following end-of-service generator replacement surgery. It was also indicated that the patient experienced migraine headaches and pain in the throat with stimulation. Review of x-ray views of the device did not reveal any obvious anomalies that could have contributed to the reported erratic stimulation event. The patient's device was replaced for erratic stimulation. The explanted products were returned to the manufacturer for product analysis. Product analysis has been completed on the lead portion. Based on the findings, there is no evidence to suggest a discontinuity in the lead which may have contributed to the reported allegation. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abrasions in the insulation of the inner tubing were visualized during analysis of the lead. This condition could potentially have an impact with the intended delivery of stimulation. If present, an intermittent short-circuit could have potentially contributed to the patient's erratic stimulation, migraine headaches and pain in the throat events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492060
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« Reply #7 on: March 23, 2012, 08:36:09 AM »

Model Number 302-30
Event Date 11/21/2002
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt was unable to perceive stimulation after her initial implant surgery, even with the device programmed to maximum settings. The pt's implanting surgeon also stated that he was concerned by the fact that the pt did not experience any events of voice alterations at these settings as well. System and normal mode diagnostics were performed repeatedly and each test resulted in a dcdc code of zero. X-rays of the pt's device were reviewed by her surgeon and no anomalies were reportedly identified. Later the pt underwent exploratory surgery, during which the electrode portions of the pt's lead were repositioned on her vagus nerve. Follow up with the pt's implanting surgeon revealed that the pt was able to perceive stimulation following electrode repositioning.

Manufacturer Narrative
Implanting surgeon reviewed x-rays of implanted device. X-rays reviewed by the implanting surgeon, no gross lead discontinuities visualized.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492063
« Last Edit: November 23, 2015, 02:34:42 AM by dennis100 » Logged
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« Reply #8 on: March 23, 2012, 08:36:33 AM »

Model Number 302-20
Event Date 05/01/2004
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt was experiencing events of painful stimulation with neck rotation. Follow up with the pt's treating vns therapy physician revealed that a decrease in the pt's therapy settings had not resolved the issue through the symptoms had improved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492064
« Last Edit: November 23, 2015, 02:35:07 AM by dennis100 » Logged
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« Reply #9 on: March 23, 2012, 08:37:04 AM »

Model Number 300-30
Event Date 07/11/2004
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported to manufacturer that the vns patient presented at the er on (b) (6) 2004 with severe neck pain with stimulation of the vns device. Both normal mode and system diagnostic tests were performed on that date, and revealed normal device function. The er physician decreased the pulse width setting from 500usec to 250usec, and the pain improved.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1492072
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« Reply #10 on: March 23, 2012, 08:37:28 AM »

Model Number 302-20
Event Date 07/24/2009
Event Type Malfunction
Event Description
Reporter indicated a vns pt had a systems diagnostics dcdc code result of 0. The pt previously had dcdc codes of 1 and 2. The pt has also been experiencing painful stimulation at the neck and generator sites. The reporter suspects a possible short-circuit condition with the vns lead. The vns has been disabled and vns revision surgery is likely, but a surgery date has not been set.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1490567
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« Reply #11 on: March 23, 2012, 08:37:59 AM »

Model
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« Reply #12 on: March 23, 2012, 08:38:28 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 01/01/2006
Event Type Malfunction
Event Description
As part of a retrospective complainant review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns pt was experiencing increase in seizures, not above pre-vns baseline. Pt was also complaining about blurred vision, headache and dizziness. However, current information may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477520
« Last Edit: November 23, 2015, 02:37:35 AM by dennis100 » Logged
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« Reply #13 on: March 23, 2012, 08:39:03 AM »

Model Number 300-20
Device Problems Low impedance; Electrical shorting
Event Date 01/01/2006
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns pt was experiencing pain in the base of the neck that radiates through the left side of the face and to the apex of the head. Pain was related to stimulation. Pain was resolved with change in parameters. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477521
« Last Edit: November 23, 2015, 02:38:04 AM by dennis100 » Logged
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« Reply #14 on: March 23, 2012, 08:39:35 AM »

Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported to the mfr that the vns pt was seen by the treating physician for a follow up visit due to an increase in seizure activity, below the pre-vns baseline, and the pt was no longer feeling normal delivery of stimulation. The pt subsequently had the generator replaced. The explanted generator was returned to manufacturer, where analysis confirmed proper generator function.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477522
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« Reply #15 on: March 23, 2012, 08:40:03 AM »

Model Number 302-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected but did not cause or contribute to a death.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported the pt began experiencing an increase in seizures and could not feel magnet or normal mode stimulation. The treating physician performed a system diagnostic test at a follow up appointment following the onset of the events, which revealed a dcdc code of "0", and the eos status was set to no. The pt subsequently underwent surgery where the generator was replaced. The explanted generator was not returned to mfr for analysis. Follow up with the treating physician has been unsuccessful regarding the status of the pt after re-implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477523
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« Reply #16 on: March 23, 2012, 08:40:39 AM »

Model Number 300-20
Device Problem Circuit Failure
Event Date 11/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected but did not cause or contribute to a death.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short circuit condition. It was reported to the manufacturer that the vns pt presented at the treating physician's office with an increase in breakthrough seizures, relationship to pre-vns baseline unk. No intervention was reported to have been taken. A system diagnostic test performed following the onset or the increase in seizures revealed a dcdc code of "0", and the end of service status was set to no.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477524
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« Reply #17 on: March 23, 2012, 08:41:14 AM »

Model Number 302-20
Event Date 12/01/2006
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedances events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported to manufacturer that the vns pt had a major fall and following the fall, the pt could no longer tolerate stimulation due to painful stimulation, feeling that the device was constantly stimulating at times, and experiencing severe coughing during stimulation. System diagnostics performed following the fall revealed a dcdc code of "0", and end of service status was set to no. X-rays were sent to manufacturer to review, and there were no lead discontinuities identified. The physician opted to disable the device as intervention, and the adverse events resolved. The device remains off and still implanted in the pt.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device malfunction is suspected but did not cause or contribute to a death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477525
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« Reply #18 on: March 23, 2012, 08:41:51 AM »

Model Number 300-20
Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possible related to a short-circuit condition. It was reported that the vns pt had been experiencing a gradual increase in voice alteration and throat discomfort with stimulation. There had been no recent setting changes or trauma that could have contributed to the events. The pt was seen by the physician following the onset of the reported events where the device settings were altered to help with the discomfort. The pt was tolerating the setting changes well and the discomfort had immediately improved. Diagnostic testing was performed which revealed a system diagnostic dcdc code of "0" and a normal mode dcdc code of "1".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477527
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« Reply #19 on: March 23, 2012, 08:42:32 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported to mfr by the vns pt's caregiver, that the pt began experiencing increased coughing and choking sensation during stimulation of the device. According to the reporter, there had been no recent programmed setting changes, trauma, or manipulation of the device that could be contributing to the onset of the events. The pt was seen by the treating physician due to the coughing and dysphagia events, and the vns device output setting were decreased to help with the events. A system diagnostic test was performed at this office visit and revealed a dcdc code of "0". The setting change improved the coughing and dysphagia temporarily, until several weeks later, the events continued, again with no reports of trauma or manipulation. The device was temporarily disabled where the events resolved. The device settings were programmed back on shortly thereafter as the pt was receiving efficacy for their seizure disorder. Good faith attempts to obtain additional info from the treating physician have been made, but have been unsuccessful to date.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1477528
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« Reply #20 on: March 23, 2012, 08:43:09 AM »

Model Number 302-20
Event Date 01/01/2006
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was initially reported by a pt's mother that her daughter was experiencing an increase in seizures and she thought the device may be nearing eos. F/u with the physician's office revealed that the pt's seizures were not above pre-vns baseline, and that they did not think it was an increase. It was additionally reported that diagnostics were performed in (b) (6) 2007, showing proper device function. Nurse indicated that pt was given a new medication to try, but that they had not heard back from the mother since the (b) (6) appointment.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476454
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« Reply #21 on: March 23, 2012, 08:43:38 AM »

Model Number 300-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the pt experienced an increase in seizures below pre-vns baseline. A battery life calculation with sufficient programming history estimated over 2 yrs remaining and during diagnostic testing the eri-no. System and normal mode diagnostics were within normal limits, indicating proper device function. The treating physician did not indicate a cause for the increase in seizures, but the duty cycle was increased.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476455
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« Reply #22 on: March 23, 2012, 08:44:13 AM »

Model Number 302-20
Event Date 05/29/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt was not able to perceive stimulation after being re-implanted with a new generator. Add'l info received from the neurologist indicated that stimulation was present at some point and now the pt was not able to feel either normal or magnet mode stimulation. Diagnostic results were within normal limits, however, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476460
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« Reply #23 on: March 23, 2012, 08:44:48 AM »

Model Number 302-20
Event Date 07/10/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns pt experienced an increase in seizures. The treating nurse indicated the seizures were below pre-vns baseline and diagnostics were within normal limits. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476463
« Last Edit: November 23, 2015, 02:43:33 AM by dennis100 » Logged
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« Reply #24 on: March 23, 2012, 08:45:25 AM »

Model Number 302-20
Event Date 06/26/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt experienced painful stimulation in the neck area. Good faith attempts to obtain add'l info from the treating neurologist have been unsuccessful at the moment. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476467
« Last Edit: November 23, 2015, 02:45:04 AM by dennis100 » Logged
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« Reply #25 on: March 23, 2012, 08:45:55 AM »

Model Number 300-20
Event Date 06/25/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns pt experienced an increase in seizures. The treating nurse indicated the seizures were below pre-vns baseline. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476468
« Last Edit: November 23, 2015, 02:45:50 AM by dennis100 » Logged
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« Reply #26 on: March 23, 2012, 08:46:21 AM »

Model Number 302-20
Event Date 06/09/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns pt experienced intermittent acute pain on the anterior left side of the neck. The treating physician stated the pain was likely related to implantation and unlikely related to stimulation. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476470
« Last Edit: November 23, 2015, 02:46:28 AM by dennis100 » Logged
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« Reply #27 on: March 23, 2012, 08:46:53 AM »

Model Number 302-20
Event Date 01/01/2008
Event Type Malfunction
Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt experienced an increase in seizures that were above pre-vns baseline. Based on the clinical symptom and the diagnostic history of the pt's device, the neurologist stated the increase in seizures was related to low levels of therapeutic medicament and not related to vns therapy as the pt is doing well after medication was increased. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476472
« Last Edit: November 23, 2015, 02:47:06 AM by dennis100 » Logged
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« Reply #28 on: March 23, 2012, 08:47:23 AM »

Model Number 300-20
Event Date 07/22/2008
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt experienced neck pain with stimulation of the device. The magnet was placed over the generator and the pt was evaluated by the neurologist the following day. F/u from the neurologist revealed normal and system diagnostics to be within normal limits. The neurologist reduced the output current and the pt was relieved from neck pain. However, current info may suggest a possible relationship to the short-circuit condition of the implanted lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476474
« Last Edit: November 23, 2015, 02:47:41 AM by dennis100 » Logged
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« Reply #29 on: March 23, 2012, 08:47:56 AM »

Model Number 302-20
Event Date 11/07/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device, this file was found to be possibly related to a short-circuit condition. It was reported that a vns pt had experienced muscle spasms in the neck and throat during stimulation. No interventions were taken for these events. If present, an intermittent short-circuit could have potentially contributed to the pt's muscle spasms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1476476
« Last Edit: November 23, 2015, 02:48:22 AM by dennis100 » Logged
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