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Author Topic: Numbness/Tingling  (Read 25981 times)
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dennis100
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« Reply #120 on: June 09, 2018, 02:01:12 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 11/01/2004
Event Type  Malfunction   
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day. The patient also reported that his left arm felt heavy and numb. Follow up with the patient's neurologist revealed that the neurologist was unaware of the events. During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics. The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529711
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dennis100
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« Reply #121 on: June 09, 2018, 02:01:48 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/14/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to feeling constant pain at her generator site for an hour, which she believed to be continuous stimulation from the device, and she was also experiencing constant tingling in her arm. The physician stated that there were no reported traumatic events prior to the constant pain. The physician was educated on how to use the magnet to disable the device until it could be communicated with. It was reported later in the same day that the patient was feeling painful stimulation every 5-7 minutes. The patient had reportedly seen her neurologist and described her pain, but nothing was changed and the pain got worse so the patient went to the emergency room. The hospital staff called the next day to report that the patient was still having continuous stimulation, but they had not been using the magnet to disable the device as instructed. A company representative was able to communicate with the patient's device, and system diagnostics were within normal limits. The patient stated that she felt the stimulation when diagnostics were performed. The neurologist had come in the night before and programmed the device off. Since the device was programmed off. The painful stimulation resolved immediately after the device being programmed off. The patient had generator replacement surgery. The device has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7504920
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dennis100
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« Reply #122 on: June 12, 2018, 12:26:36 AM »

Model Number 304-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was reported that the pt experienced a seizure at the airport (was seizure-free for a few months prior to this). She was then brought to a hospital where they performed an mri. Per pt, her magnet was taped over her vns generator for the mri and during the mri, the magnet moved up her chest along the lead causing bruising. Following the mri, the physician at the hospital turned her settings down to the lowest possible settings against pt request. Pt then experienced 12 seizures in 12 hours and was put into a medically induced coma. Pt indicated she has some left-sided numbness and weakness since event and feels she has "left-sided neuro deficit". Pt also indicated that prior to the event, she was being weaned off her medications, which may have caused the seizure at the airport. Pt was seen by her physician a few weeks after event and the device was found to be functioning fine. The physician is ramping up the pt's settings and the pt is doing well. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662335
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dennis100
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« Reply #123 on: July 06, 2018, 10:12:00 AM »

Model Number 300-20
Device Problem Fracture
Event Date 06/04/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that she had tingling sensation in her hands due to the vns. Later it was identified that high impedance was detected on the patient's vns through system diagnostics. The patient underwent a full revision of the vns. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7651952
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dennis100
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« Reply #124 on: August 14, 2018, 12:46:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2018
Event Type  Injury   
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.
 
Event Description
Further information was received that despite the generator being disabled, the patient continued to experience the previously reported adverse events, specifically pain. It was stated that the paint occurred in the generator area and was associated with left upper extremity pain and some numbness. Because of this, the patient requested both the lead and generator be removed. The physician reportedly advised that the pain the patient was feeling was likely not from vns, but a definitive assessment was not made. No surgical intervention has occurred to date. No additional relevant information has been received.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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dennis100
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« Reply #125 on: October 06, 2018, 05:02:37 AM »

Model Number 300-30
Device Problem Fracture
Event Date 08/21/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A physician reported receiving an error message while interrogating a patient's device stating current could not be delivered. Diagnostics were performed on the patient's device and impedance was found to be high. It was noted that this was high impedance and indicative of a lead fracture. The patient's device was disabled and the patient was referred for surgery. It was noted that the patient was feeling tingling at the check and neck sites. A full revision surgery was performed. No device has been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877449
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dennis100
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« Reply #126 on: November 10, 2018, 02:49:57 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/16/2018
Event Type  Injury   
Event Description
It was reported from the physician that the patient was admitted to the hospital for symptoms of voice changes and neck pain and tingling. The doctor stated that it started 5 days prior and the patient came to the emergency room for the symptoms. The doctor asked what generator the patient had as he was unable to interrogate the patient. He later stated that everything resolved but it is unclear exactly what this means. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7970413
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dennis100
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« Reply #127 on: January 03, 2019, 08:59:06 AM »

Model Number 303-30
Event Date 09/09/2011
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that the patient¿s generator and lead were explanted electively on (b)(6) 2014 as the patient reported no improvements to their seizure control since being implanted with the device and was experiencing some discomfort. The explanted lead and generator were returned for product analysis on (b)(4) 2014. The nurse later clarified that the discomfort the patient was feeling was in fact shortness of breath and numbness extending from the incision to the chin. The numbness was felt by neurosurgery to be due to injury to subcutaneous nerve during incision. The device had been disabled since (b)(6) 2012. The patient wanted the device off and refused parameter adjustment. The shortness of breath was due to device stimulation. It was stated that the explant surgery was not to preclude a serious injury. Diagnostics were not performed on the vns as the highest the patient was programmed to was an output of 0. 75ma. No causal or contributory programming or medication changes preceded the onset of the events. The nurse stated that she believed vns was not programmed to more therapeutic parameters due to poor tolerance and therefore was not effective. Product analysis was completed on the generator on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead is still underway.
 
Event Description
Analysis of the lead was completed on (b)(6) 2014. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637198
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dennis100
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« Reply #128 on: January 04, 2019, 09:42:46 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
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dennis100
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« Reply #129 on: January 04, 2019, 09:43:45 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859
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dennis100
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« Reply #130 on: January 11, 2019, 02:50:31 AM »

Model Number 300-20
Event Date 12/23/2013
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 7035 ohms). The patient reported that he felt stimulation and knew that he had damaged the device. The patient¿s device was subsequently programmed off. It was reported that the patient had a fall that is believed to have caused or contributed to the high lead impedance. X-rays were taken and were reported by the neurologist to be unremarkable. The notes indicate that during an office visit on (b)(6) 2013, the patient reported feeling a tingling sensation 2-3 times a week at his generator site. The neurologist stated that there may have been an issue with the patient¿s electrode as a warning message appeared during the office visit; however, diagnostic results during the office visit showed lead impedance (impedance value ¿ 3601 ohms) within normal limits. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product information was obtained. An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead have not been returned to the manufacturer to date.
 
Manufacturer Narrative
Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Date of implant; corrected data: the previous mdr incorrectly reported the implant date. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative
Date of event, corrected data: the initial manufacturer report incorrectly reported the date of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3766185
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dennis100
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« Reply #131 on: January 15, 2019, 03:26:31 AM »

Model Number 302-20
Event Date 04/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent revision surgery. Follow-up with the implant facility revealed that the explanted product was discarded following surgery.
 
Manufacturer Narrative
Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. Evaluation codes, conclusions; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. It is unknown if the explanted device was explanted.
 
Event Description
Additional information was received stating that the patient¿s generator was replaced on (b)(6) 2014. The patient¿s lead was not replaced at this time. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results showed high lead impedance (dc dc ¿ 4). Subsequent normal and system diagnostics showed lead impedance within normal limits (dc dc ¿ 3). The patient reported that she noticed a change with her device. The patient was no longer able to perceive stimulation or voice alteration two days prior to the office visit on (b)(6) 2014. The patient also reported having hypoesthesia at her neck. No medication changes or programming changes occurred that could have caused or contributed to the hypoesthesia or decreased perception of stimulation. The patient reported no trauma related to the event. The neurologist stated that the patient¿s issues were due to battery depletion despite diagnostics showed eri = no. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. The notes indicate that the patient's device could not be interrogated during an office visit on (b)(6) 2013 so no diagnostic results were performed at that time. A battery life calculation using the available programming history showed approximately 3. 68 years until eri = yes. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3816311
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