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Author Topic: Misc. Cardiac  (Read 34158 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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dennis100
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« Reply #393 on: June 03, 2019, 05:18:07 AM »

Model Number 103
Event Date 01/11/2013
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized on (b)(6) 2013 after having two grand mal seizures. The patient's mother reported that the patient had not experienced a grand mal seizure in five years. It was reported that while the patient was hospitalized she began to experience irregular heart rhythms after the second grand mal seizures. The patient's mother explained that the patient's heart rate would decrease when the patient stood up and would increase upon lying down. During the hospitalization the patient also began to experience shortness of breath. The patient's mother indicated that the patient's physician "blew off" the issue. Attempts to obtain additional information are underway; however, no additional information has been received to date.
 
Event Description
Follow up with the patient's mother indicated that the physician is talking about either programming the vns device off for a trial run or having it explanted because he feels that the vns is not covering the type of seizures that the patient has. Attempts have been made for additional information; however, they have been unsuccessful. No other information has bene provided.
 
Event Description
Additional information was received that product analysis was completed on the generator. 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.
 
Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026508
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dennis100
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« Reply #394 on: June 07, 2019, 05:54:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced sharp pains in their chest and neck with stimulation which began after a face forward fall. It was additionally reported by the representative that the patient experienced heart rate issues. Internal data of the patient's generator was reviewed and there was no evidence of any malfunction or anomalies with the generator. No further relevant intervention has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8597935
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dennis100
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« Reply #395 on: June 08, 2019, 07:20:14 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had experienced constant autostim stimulations, making him sweat, vomit, and causing a sore neck. The patient reported that he could not sleep, and that the pain went from his neck up to his ear, and his symptoms did not change according to what position he was in. Once the magnet was taped over the patient's generator, the symptoms went away. The patient visited his neurologist and the device was disabled. At the time the interrogation revealed nothing remarkable in terms of diagnostics. It was reported that the patient was feeling fine over the weekend and there was no reason to suspect that the autostim's frequent stimulation was due to the patient's heart rate being higher than normal. The device was turned back on later with autostim remaining disabled. Programming history was reviewed from the generator and no anomalies were seen. The amount of autostimulation per day was similar across the weekend of the event as compared to previous time periods. The amount of total stimulation per day was similar before the event and during the event. The patient was referred for replacement in order to have day night features, and due to the patient¿s belief that the autostim function of the generator was not working. Surgery is likely but has not occurred to date. No additional or relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8639935
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dennis100
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« Reply #396 on: June 19, 2019, 04:36:02 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/19/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient's device was disabled upon interrogation. It was discovered that the device had been disabled for a long time due to the patient being hospitalized complaining of choking sensations and cardiac issues. The device was turned off and the patient has not experienced any of these issues since then. The doctor decided to keep the device disabled for now. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7116656
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dennis100
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« Reply #397 on: July 02, 2019, 01:34:12 AM »

Model Number 103
Event Type  Injury   
Event Description
It was reported that a vns pt experienced an arrhythmia described as av block type ii as a side effect from vns therapy. Further information was received from the treating physician indicating the pt did not have any prior history of cardiac events and the av block occurred post operatively. Moreover, the physician indicated the arrhythmia did not correlate with the on time of the programmed device settings and did not occur while performing diagnostics. However, the av block occurred after a setting change as the output current was increased from 1 ma to 1. 5 ma. The treating physician believes vns exacerbated the av block and determined to be related to stimulation. At the moment, interventions taken were to program vns off and monitor the pt as the event recurred after vns was off. The treating physician would like to continue vns therapy while maintaining the pt under cardiac monitoring. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1641397
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dennis100
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« Reply #398 on: July 20, 2019, 10:59:57 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that during a visit to a developmental home, the company representative was approached by a woman who informed him that the vns had "fried her niece's heart and killed her. " the woman walked away immediately and no further information was provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7958253
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dennis100
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« Reply #399 on: August 10, 2019, 03:27:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2019
Event Type  Injury   
Event Description
A report was received that a patient has chest pain, increased heart rate, and coughing when the patient is around any metal - notably spoons and the patient's magnet. The patient stated that the neurologist lowered their settings to as low as they can go and the patient is still experiencing these events. Further follow up with the physician's office revealed that the patient has not yet been seen by the physician, but that the patient's nurse believes the patient might just not be able to tolerate her current settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764840
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dennis100
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« Reply #400 on: August 10, 2019, 03:28:08 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2018
Event Type  Injury   
Event Description
It was reported that the patient felt as though his heart was skipping a beat since his replacement from a m103 to a m1000 vns generator. It was stated that the patient had a cardiac workup. It was stated that the patient may have a pacemaker. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8765124
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dennis100
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« Reply #401 on: August 10, 2019, 03:28:52 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
The patient reported via social media that she had side effects after her vns implant a year prior. She said that she could not speak and had heart palpitations. The physician reportedly disabled her device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764619
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dennis100
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« Reply #402 on: August 10, 2019, 03:29:46 AM »

Model Number 106
Device Problem Energy Output Problem
Event Date 06/24/2019
Event Type  Malfunction   
Event Description
Nurse requested vns interrogation after a patient underwent defibrillation to ensure functionality of the device. The device was interrogated and the patient's settings were noted to have been changed. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8816883
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dennis100
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« Reply #403 on: August 10, 2019, 03:30:34 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/30/2018
Event Type  Malfunction   
Event Description
It was reported by the patient's caregiver that the patient experienced heart rate increases correlating with the patient raising their arm. It was reported that the caregiver felt the patient's heart was pounding in their chest. The patient's vns settings were turned down by the neurologist; however, their seizures reportedly returned. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8780114
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dennis100
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« Reply #404 on: August 10, 2019, 03:31:28 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the er for bradycardia, syncope, and a possible heart blockage. The physician was questioning whether this was related to the vns. It was stated that the patient had been bradycardic ever since implant. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764641
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dennis100
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« Reply #405 on: September 07, 2019, 02:59:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a cardiologist that a vns patient was experiencing syncope and her blood pressure was stated be "bottoming out". The physician stated that when the patient stands up or lies down, they have a spell intermittently which drops their blood pressure from 180/100 to 100/80. The physician desired the vns to be disabled to see if the adverse events were related to stimulation. Further information was received that the patient is having severe side effects, specifically uncomfortable twitching at the generator site, slowing heart rate, and dropping blood pressure. It was stated that when the generator was disabled with the magnet, the adverse events ceased. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes stated that the patient is having issues with her vns misfiring, and states that she has been experiencing low blood pressure, syncope episodes. The cardiologist advised to have the vns turned off. The patient has experienced several seizures since having the vns disabled by the magnet but the disablement has lessened the patient's syncope episodes. The cardiologist does not believe that her symptoms are coming from her heart but the vns unit. It was stated that the vns has been disabled at this time. 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=8884891
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dennis100
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« Reply #406 on: September 07, 2019, 02:59:59 AM »

Model Number 302-20
Device Problem Appropriate Term/Code Not Available
Event Date 07/11/2019
Event Type  Malfunction   
Event Description
Patient underwent defibrillation and reported experiencing a chocking sensation and painful stimulation/shocking following the event. Per the patient's neurology office, the lead wire was fried. The device was disabled. It was noted that the cardioversion had burned the vns wire and that the patient was referred for device replacement. 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=8885889
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dennis100
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« Reply #407 on: October 12, 2019, 03:15:22 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 09/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was in the hospital with "stimulation-related dyspnea and stridor. " it was reported that the patient's throat would close to 5 - 6 mm in diameter when stimulation occurred; which prevented the patient from breathing properly. It was reported that the magnet was used to disable the generator stimulation. It was reported that there was a low impedance reading detected. The representative indicated that the low impedance may be caused by the patient's "ziopatch or holter monitor for atrial fibrillation. " it was reported that the patient's left vocal cord was being paralyzed with stimulation. The patient's generator was disabled due to the reported adverse events. At the time of the report, it is unclear whether the low impedance is causing/contributing to the left vocal cord paralysis with stimulation. Mfr report # 1644487-2019-01883 captures the patient's vocal cord paralysis with stimulation. This report captures the patient's low impedance reading. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9127224
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dennis100
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« Reply #408 on: October 12, 2019, 03:16:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/23/2019
Event Type  Injury   
Event Description
It was reported by a cardiologist that the patient was hospitalized due to severe bradycardia and sinus pauses. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9078984
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