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Author Topic: Deep brain stimulator - Dizziness/Fainting  (Read 21662 times)
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dennis100
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« Reply #30 on: March 29, 2014, 12:26:54 AM »

Model Number 37603
Event Date 10/29/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported that one unit ¿right generator, on the left side¿ was showing it had been off. It was noted that during that time the patient had had trouble going down hills. On (b)(6) 2013, the healthcare professional reprogrammed the implantable neurostimulator (ins), stimulation was set at 2. 0v on the right generator on the left side. It was further noted that stimulation was set so that the patient's stimulation could be adjusted in the range of 0. 0v-2. 0v. The patient was not feeling well and had had ¿no sense of well-being. ¿ it was further noted that the patient had not had the same feeling normally when stimulation was off. On sunday morning (b)(6) 2013 at about 9am, stimulation was turned on and lowered. When the right generator was turned on and they went to reprogram it and highlighted the voltage to lower it the patient responded ¿whoa! what did you do there?¿ the ins was turned off and interrogated. Stimulation was turned down to a tenth of the volt. Since sunday morning prior to this report, the patient had been doing a lot better. Programmer told them patient was off and patient was actually not off and turning at 2v. Patient did not have symptoms like she first had when stimulation was turned off because, she was on ¿carb levo. ¿ 2v setting was ok but 24-48 hours later the patient did not like the setting. Stimulation was turned down. Additional information requested but had not been received as of the date of this report. Additional information received reported the healthcare professional was not adjusting the deep brain stimulator. Further follow up reported the cause of event was the patient had side effects to stimulation at all contacts. No abnormal impedances were noted. It was noted therapeutic settings had not been found despite multiple settings. It was noted an appointment was scheduled to have a representative assist with programming. Signs and symptoms associated with the event included dizziness, light headed and freezing. There was no hospitalization required due to the event and no injury to the patient. Additional information received reported the patient was scheduled for reprogramming on (b)(6) 2014. Additional information received reported the patient came in for reprogramming on (b)(6) 2014. It was noted that the patient was still doing poorly after being reprogrammed. Patient had an mri and the leads looked to be posterior and medial. It was noted that the patient may need to have a lead revision surgery. Nothing was scheduled at that time. The healthcare professional was going to discuss with another healthcare professional about the possibility of surgical intervention. Additional information reported that the patient was going to have a revision of the lead that is placed in their left hemisphere. It was noted, the health care professional thinks the lead is misplaced and the patient will be scheduled for revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3604677
« Last Edit: February 07, 2015, 12:06:56 PM by dennis100 » Logged
dennis100
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« Reply #31 on: July 04, 2014, 09:20:25 PM »

Model Number 37603
Event Type Injury
Patient Outcome Hospitalization,Other
Manufacturer Narrative
Concomitant products: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387, serial # (b)(4), implanted: (b)(6) 2007, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v805902, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

Event Description
It was reported that the patient had blacked out on monday prior to the date of this report. It was noted that the patient had episodes of dystonic seizures that lasted 45-50 seconds. It was further noted that the patient had blacked out a few times since monday prior to the date of this report. It was noted that someone at the hospital thought the right implant had a short. The patient would not get the device reset or checked for 2 weeks. The patient fell 2 months prior to the date of this report but they did not think this was related to the current incident. Patient¿s status was unknown. The patient was admitted to the hospital. It was later reported that the patient was ¿having seizures because of a faulty unit. ¿ this had started (b)(6) 2014. Therapy was not working as expected. There was a loss of therapeutic effect. Additional information received reported the patient was still having concerns with their device or therapy but was working with their doctor or manufacturing representative. The patient had an appointment on (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3843992
« Last Edit: February 07, 2015, 12:07:32 PM by dennis100 » Logged
dennis100
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« Reply #32 on: September 06, 2014, 12:43:55 AM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was originally reported on (b)(6) 2013 that the patient was feeling really hot in the chest on the left side where the implant was located, and also in the head and back. It was stated that the patient also felt dizzy. This started two weeks prior to the report. It was stated that it could be her menopause, too. The patient also felt that stimulation was too strong and that it made her muscle tense up more than the previous implant. She started at 2. 50 v with this system, but in her previous system her range was 0-2. 50. About eleven months later it was reported that the patient¿s neck was hot and this started one year ago. The patient was told that her lead was fractured and she was scheduled for device removal on (b)(6) 2014. The patient wanted to know what she could do about the heat and noted that she got the remote, synched with the implantable neurostimulator (ins), and stimulation showed off. The patient had spoken with her healthcare provider (hcp) and the office, but they would not move up the surgery date and they did not have any direction on what she could do in the meantime. Additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(6), product type programmer, patient; product id 64002, lot # n390514, implanted: (b)(6) 2013, product type adapter; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(6), implanted: (b)(6) 2005, product type extension; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3973603
« Last Edit: February 07, 2015, 12:07:57 PM by dennis100 » Logged
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« Reply #33 on: October 13, 2014, 12:55:20 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v230715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported that the patient had a stimulator in her chest for essential tremors with parkinson¿s. There was a loss of therapeutic effect. There was a sudden onset of symptoms. Onset was following the patient¿s neighbor had started up a lawn mower while the patient was sitting outside reading a paper and it was so loud and the patient had not known until it was too late, the damage had already been done. The patient had not gone anywhere when this had occurred on the day prior to the date of this report, she had not even left the house. Patient symptoms included tingles down her arm, legs and face, a dull ache in her left ear that she had after surgery and it was back the time of this report and hearing issues. The patient was right handed and the implant was in her left chest. The patient¿s right hand was usually very steady, but was shaking at the time of this report. The patient was unable to hold a toothbrush, fork, a pen or anything. The patient checked her device and it said on with a black triangle and the patient checked again and it said on and ok. The patient had checked her device twice on the day prior to the date of this report to make sure she was on and it was. There had been no problems with the patient¿s previous stimulator, which the patient had for 5 years before having it replaced and the current stimulator had been nothing, but problems/issues. The patient had issues with it since (b)(6) 2014 when it was implanted. The patient looked as though she had a pack of cigarettes sticking out of her chest and the wires looked like they were sticking out of her neck and had not before. The incision was healed and there was no tenderness or redness over the scar. Prior to (b)(6) 2014, the patient had been getting control of her symptoms, but it had been sending her into circles, which meant she was dizzy and had shakes in her right and left hand and pin pricks all over her legs and arms. A healthcare professional had instructed her to turn stimulation on and leave it on and not to turn stimulation off at night in order to prevent side effect. The patient would experience the ¿circles¿ when she had the device off and turned it back on. No interventions or outcome were provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078338
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dennis100
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« Reply #34 on: November 08, 2014, 01:13:27 AM »

Model Number 37602
Event Date 09/30/2014
Event Type Injury
Event Description
It was reported that the patient fainted and lost consciousness while being programmed at the doctor¿s office. The patient was sent to the emergency room (er) via ambulance. At the time of the report the patient was alive with no injury. The exact reason for the patient fainting was unclear, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v015431, implanted: (b)(6) 2007, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4185135
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« Reply #35 on: January 10, 2015, 11:24:14 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 3389-40, lot# j0104134v, implanted: (b)(6) 2001, product type: lead; product id 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v227370, implanted: (b)(6) 2009, product type: lead. (b)(4).

Event Description
It was reported that starting sunday prior to the date of this report that patient felt like the device had a shot circuit but had not heard anything. It felt like buzzing intermittently in the patient¿s head and he got dizzy. Therapy had been good besides that and nothing had specifically set it off that the patient remembered. The patient had stopped taking his depression medications prior to halloween. There were no falls or traumas noted. Impedances were: 0 and 1 ¿ 50 ohms and c,0 and c,1 were normal. Impedances were first noted at the patient¿s last programming session on (b)(6) 2014 along with the 273 drain. The patient was programmed with +2-1-0, 2. 0v, 60pw, 185 rate and 900 ohms. A longevity estimate calculation was done and showed 79 months or 6. 58 years. Battery voltage was 3. 74v. The patient had elected to have the battery changed and impedances would be checked intra-operatively, they would change the extension if it was still showing a short. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4291732
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dennis100
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« Reply #36 on: February 07, 2015, 12:08:40 PM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the device had worked wonderful for the patient¿s upper extremities, but they had dystonia in their left foot that caused their foot to be at almost a 90 degree angle. It had helped with all other symptoms besides the patient¿s foot. This made it impossible for the patient to walk and they kept falling. The patient had this problem before implant. The patient¿s healthcare provider (hcp) instructed them to turn the device off. The hcp thought they could help fix the issues, but wanted the patient to turn stimulation off for a week to week and a half, so they could start over. The patient later reported that he turned stimulation off, but program c was still on. About a month later the patient still had concerns regarding his device or therapy, but was working with their hcp or a manufacturer representative. The patient had an appointment on (b)(6) 2014. The patient knew what a, b, and c were, but wanted to know what they control. The patient wrote that a felt like it was in their legs, b in their voice and they were stuttering, and they did not know what c did. The patient stated they used all three. Six months later the patient reported the patient programmer screen showed the ¿check the implantable neurostimulator (ins)¿ screen. There was a problem with the programmer and the programmer worked intermittently. When the patient checked the ins they got the stimulation turned off screen. The patient tried to turn stimulation back on, but they could not make a connection. The patient saw stimulation off and a flashing triangle with the battery on the top row of the programmer and 3. 108 below that. Usually the patient could feel a small voltage going through their body when they move to program b or c, but they did not feel anything at the time of this report. The patient¿s wife stated that it had been worrying the patient a good bit because they had to use the ins more than ever. The patient had symptoms of slurred speech. The patient had turned the ins off for a short period of time and they have never had any trouble with it so they assumed it was the batteries. The reporter stated the patient was beginning to get it a little on the right side. The patient had dystonia real bad and ¿afib¿ that caused them to fall almost every day. When the patient¿s hcp ¿hooked up the final wires¿ the patient was walking again, but their left foot was turning in. The reporter stated the hcp told them that normally the patients get better and they had never seen one get so bad. The patient¿s right foot turned towards the middle and they had a brace on it. The patient did use a walker to walk. The patient¿s foot started turning in about three weeks after surgery. For the past six months the patient was starting to get dizzy when they stood up and tried to take a step. The patient had fallen once close to thanksgiving and then again about six weeks prior to this report. After the first fall the patient had a concussion and after the second fall the patient was taken by ambulance to the hospital because they thought their hip may be broken. The patient had been to the orthopedic hcp twice since then. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3 387s-40, lot# va09grv, implanted: (b)(6) 2013, product type: lead; product id 748351, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386252
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« Reply #37 on: February 07, 2015, 12:09:19 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had three implantable neurostimulators (ins), one of which was dead. The reporter noted that ¿the batteries implanted a year ago were dead. ¿ the reporter was unable to confirm if the two active inss were on or off. The patient had a loss of efficacy unrelated to stimulation therapy; he was experiencing light headedness, dizziness, and hypoxia. These symptoms were believed to be device related and the patient was admitted to the hospital the day prior to the report. The reporter tried to reach out to both physicians involved with the patient, but both were ¿clueless. ¿ the patient outcome was not reported, so additional information was requested. If additional information is received, a supplemental report will be sent. Refer to manufacturing reports #3004209178-2015-00006 and 3004209178-2015-00015 for both of the other inss.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v813689, implanted: (b)(6) 2012, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377442
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dennis100
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« Reply #38 on: August 08, 2015, 10:15:44 AM »

Model Number 37601
Event Date 07/03/2013
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va04z6f, implanted: (b)(6) 2013, product type lead; product id 3708660, lot # nkn045745v, implanted: (b)(6) 2013, product type extension; product id 3708660, lot # nkn045747v, product type extension. (b)(4).

Event Description
It was reported the patient had a syncopal episode that was originally noted as no relation. Additional information indicated it was unknown if the syncopal episode was related to the study or programming. In-patient hospitalization was required due to the event and levetiracetam was given as an intervention. The event was considered resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898563
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« Reply #39 on: September 16, 2015, 11:57:08 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 07/26/2010
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. At this time, no additional information was available, additional information has been requested.

Event Description
Literature: ackermans l, duits a, temel y, et al. Long-term outcome of thalamic deep brain stimulation in two patients with tourette syndrome. J neurol neurosurg psychiatry. Oct 2010; 81 (10): 1068-1072. Summary: the authors conducted a follow-up study to report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described tourette patients. Reportable event: in patient 2, ((b)(6) male), the tic improvement at 8 months was slightly decreased at 6 years; compulsions had disappeared. This patient showed a decrease in verbal fluency and learning, a slight decrease in depression but overall psychopathology was still high at 6 years with an increase in anger and aggression together with difficulties in social adaptation. This patient reported a reduction in energy when the current intensity reached the level necessary for an optimal effect on tics; this patient did not adjust stimulation settings and preferred the feeling of drowsiness above his tics. This patient did experience a hardware-related complication consisting of traction of the lead in the neck. Multiple revisions of the wound and local injections were carried out with partial effect. This patient received seven replacements in 6 years due to his high-voltage stimulation. This patient experienced substantial improvement in sexual functioning at 8 months after surgery, but a slight decrease at the long-term follow-up except for sexual drive that increased to the maximum level. This patient experienced difficulty with his visual adaptation and vertigo, but neither of these complaints interfered with his daily life. Examination by an ophthalmologist did not reveal any disabilities. The adverse events experiences were not considered distressing at long term follow-up. See literature article with mfr report# 3007566237-2010-1064945.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943662
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dennis100
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« Reply #40 on: September 17, 2015, 12:00:56 AM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# v550608, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v550608, implanted: (b)(6) 2010, product type: lead. (b)(4).

Event Description
It was reported that the patient only had an implantable neurostimulator (ins) implanted and the ¿cables¿ were no longer implanted due to infection. It was noted that ¿cables¿ were removed the year prior to this report due to bacterial infection. Patient needed an mri to assess for vertigo. Additional information requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3472688
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