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Author Topic: Shocking Sensation  (Read 107819 times)
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dennis100
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« Reply #330 on: June 07, 2019, 05:32:56 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
During a surgery consult appointment for "battery depletion," the patient reported a shocking sensation with the vns stimulation. The neurosurgeon has referred the patient for an x-ray prior to scheduling the patient for a replacement of their generator. 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=8578296
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dennis100
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« Reply #331 on: June 08, 2019, 06:44:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Event Description
It was reported that the patient's vns was "misfiring" and had fired 36 times in one day. The er physician indicated that the vns kept going off every minute per the patient and would not stop. Magnet disablement was recommended, but the patient and facility requested a company representative program the vns off. A second call was received from the facility. Magnet disablement resolved the issue, but it was still requested to have the vns programmed off. It was believed by the medical professional that the patient experienced painful stimulation since they requested the vns programmed off. The patient was discharged from the facility. Information was later received indicating that the ¿misfiring¿ meant the patient experienced a shocking sensation and that the medical professionals did not wish to disable the vns as they did not want the patient to have seizures. The diagnostics from the latest clinic visit after the admission were reported as within normal limits. The patient was referred for a vns lead replacement surgery due to the painful stimulation. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8654203
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dennis100
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« Reply #332 on: June 13, 2019, 03:40:34 AM »

Model Number 304-20
Device Problem Fracture
Event Type  Malfunction   
Event Description
It was reported that the patient had x-rays taken and had a lead fracture. The x-rays have not been reviewed by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
X-rays were received and reviewed by the manufacturer. Based on the images provided, no obvious source of the high impedance condition was identified. Although no gross lead fracture can be observed, a micro-fracture in the lead cannot be ruled out. A portion of the lead is possibly behind the generator and cannot be visualized, therefore a lead fracture in that portion of the lead cannot be ruled out.
 
Event Description
Additional information was received from the physician via clinic notes. They stated that the patient had an electric shock sensation in his neck which was concluded to be associated with the high impedance reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7066115
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dennis100
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« Reply #333 on: June 25, 2019, 01:48:39 AM »

Model Number 304-30
Device Problem Fracture
Event Date 09/16/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Report received that a patient's vns was interrogated and high impedance was observed. The patient reported that he stopped feeling stimulation four months prior to this observation. It was reported that trauma was not suspected to have contributed to the high impedance. No surgical interventions have occurred to date. No further relevant information has been received.
 
Event Description
It was reported that the patient was feeling a shocking sensation in his chest, so the physician programmed the device off. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7261480
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dennis100
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« Reply #334 on: August 10, 2019, 02:28:57 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital with hoarseness, electrical pain in the back of throat going up to the patient¿s teeth, and hand spasms. The er (emergency room) physician indicated that he assumed the events were related to vns. Further information was received that the patient was seen the week prior to the hospitalization and per the neurologist the device was working fine. It was noted that impedance was ok, but that the exact value could not be recalled. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8776992
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dennis100
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« Reply #335 on: August 10, 2019, 02:30:03 AM »

Model Number 103
Device Problem Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient reported on social media that she started to have problems described to be bee sting like feeling shocks all over the left side of the body and in the patient¿s stomach. Patient reported pain around the brain stem. The patient reported that the pain was getting worse in the neck wire and was unbearable. The patient noted that she was seen by a physician a month ago and it was found that the device was malfunctioning therefore it was disabled. It was noted that the pain stopped after device disablement. The patient noted that she was referred for device explant. 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=8807124
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dennis100
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« Reply #336 on: August 10, 2019, 02:30:45 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was experiencing discomfort with stimulation and the patient underwent a full revision for the pain. The patient was complaining of electric shocks to the brain and behind the eyeballs and thus the doctor went ahead with the full revision. The physician did not provide an assessment of the reported pain. It was stated, though not explicitly stated by the physician, that the revision was noted to be for the patient's complaints and their intractable seizures and therefore for both patient comfort and to preclude a serious injury and thus reported. Diagnostics were reported to be within normal limits. The patient's replacement surgery facility is known to discard products after surgery and is a no return site and therefore product has not been received. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8781134
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dennis100
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« Reply #337 on: August 10, 2019, 02:31:34 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported via letter of medical necessity received by the manufacturer that the patient complained of abnormal sensations ("electrical shocks" lasting for several seconds) in her body since last year. It was stated that this was when the patient was operating a microwave oven, but more commonly when weather disturbances/storms occurred nearby. Per the physician's labeling, properly operating microwave ovens, electrical ignition systems, power transmission lines, theft-prevention devices, and metal detectors are not expected to affect the generator. It was reported as more common recently and that the vns was disabled due to the sensations of the vns " firing off suddenly" even with no seizures reported by the patient. The patient's vns model did not have sensing capabilities and, therefore, did not provide stimulation based on tachycardia detection related to seizures, but due to the programmed on and off times. The physician felt that the current vns should be removed and replaced with the latest model as soon as possible as the patient had a good response to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8809058
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dennis100
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« Reply #338 on: August 10, 2019, 02:32:32 AM »

Model Number 10X
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported by the patient via social media that her vns was put in wrong. She said that her wire vertically entrapped her vagus nerve. She would get shocked when she swallowed at times or touched a grocery cart. She also reported that when her vns was being titrated up, it triggered asthma attacks and she had to go to the er. Later, the vns was removed, but the patient's voice turned into a whisper. After vocal cord injections and speech therapy, her voice came back but she couldn't sing. The current report captures the asthma and other stimulation related events reported as part of the story. Mfr. Report # 1644487-2019-01280, captures the report of voice alteration after device explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8761498
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dennis100
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« Reply #339 on: August 10, 2019, 02:33:55 AM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2000
Event Type  Injury   
Event Description
It was reported by the surgeon's office that the patient was going to have their device explanted. During searches, it was found that the patient had their generator explanted due to lack of efficacy and device had been disabled for some time. The device history records were reviewed and confirmed the device was within specifications when it was shipped. The explanted generator was returned for product analysis and stated generator was operating within electrical test specifications. Per the surgeon, the patient had shocking sensation after she was initially implanted and the generator was removed after one year. Information was received from the physician indicating that they did not know the cause of shocking back when it was explanted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8818260
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dennis100
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« Reply #340 on: August 10, 2019, 02:34:46 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/02/2015
Event Type  Injury   
Event Description
The surgeon's office provide a sales representative with operative notes which detailed that the patient was previously explanted on (b)(6) 2015 due to lack of efficacy and the device ¿shocking her¿. The notes mention that the surgery occurred without issue and that the patient¿s generator and lead, other than electrodes on the nerve, were removed. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8818209
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dennis100
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« Reply #341 on: September 07, 2019, 01:16:03 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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