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Author Topic: Misc. Cardiac  (Read 25101 times)
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dennis100
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« Reply #390 on: May 20, 2019, 10:10:07 PM »

Model Number 103
Device Problem Defibrillation Problem
Event Date 12/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.
 
Event Description
Further information was received indicating that the patient had undergone bi-phasic cardioversion in the morning with adhesive patches in anterior-lateral left position. The energy value used for the cardioversion was 100j. The generator's decoder spreadsheet was reviewed. On (b)(6) 2013 the patient underwent the first cardioversion treatment. On (b)(6) 2013 the battery voltage was 3. 440v and the lead impedance 3782 ohms. On (b)(6) 2013 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the patient underwent the second cardioversion. On (b)(6) 2014 the battery voltage was 2938v and the lead impedance 2401 to 2430 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621
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dennis100
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« Reply #391 on: May 20, 2019, 10:11:31 PM »

Model Number 102
Event Date 05/01/2006
Event Type  Injury   
Event Description
A cardiologist called and asked for labeling on the vns and cardioversion. She had a patient who had a vns implanted, hospitalized in icu that was in afib and she needed to cardiovert them before putting a pacemaker in. The patient was having cardiac pauses as well and she did not think it was related but was not sure. Actual start date of event unknown. Said that it occurred during the off time so that she did not think so. She said that the patient was elderly so most likely related to that but could not be 100% sure. It was asked if she had tried to disable the device to rule out the vns and she said no, since she was not having it during the on time. She felt that she did not need to do that and that it was most likely related to her age. Patient was set to 7 secs on time 3 mins off time. The patient had sick sinus syndrome with severe bradycardia requiring their pacemaker placement (b)(6) 2006 in the right chest area. No interactions with their vns were reported. During this time frame, the patient was also found to have paroxysmal atrial fibrillation and was placed on coumadin. After implant with their pacemaker, the vns device and pacemaker are reportedly were working well and the patient doing fine as well. The patient had been implanted since (b)(6) 2005, and there is no indication that this event coincides with vns stimulation. No further information will be provided in regards to their cardiac event from their physician's office. It was later reported in (b)(4) 2013 that the patient had died. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972148
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dennis100
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« Reply #392 on: May 23, 2019, 11:44:21 PM »

Model Number 102
Event Date 07/30/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809
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