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Author Topic: Deep brain stimulator - Speech  (Read 85843 times)
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dennis100
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« Reply #180 on: October 12, 2014, 04:27:11 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported by the doctor that the patient may have a system malfunction as the left side of his body developed a tonic contraction that lasted 30 seconds when the right implantable neurostimulator (ins) was turned off. The patient was seen on (b)(6) 2014 by the doctor and manufacturer representative to have the system evaluated. The patient stated that he had minimal efficacy since (b)(6) 2013 and what little efficacy he did noticed had decreased recently. He was having more speech and tremor problems. Since that date the patient had noticed the tonic contraction on the left side of his face and neck at the moment the ins turned off. The contraction was intense for several seconds and he felt numbness in his tongue. The contraction faded away after ten to fifteen minutes. The configuration was changed multiple times and the contraction was less severe. The patient was not told when the ins was turned off in order to rule out the influence. It was discovered that if the settings were slowly decreased he felt increased parasthesias in his thumb and fingertips, but he did not have the face and arm tonic contraction. Impedances were taken in several positions and while palpating. The impedances were consistent throughout and within normal range. It was noted that the placement of the lead was ¿textbook¿ and there were no historical impedance values available. The patient had reprogramming once a month to address the efficacy issues. It was eventually decided that the patient would have his right ins and extension replaced on (b)(6) 2014. The surgery had not yet occurred, so the patient outcome was unavailable. Additional information will be requested after the reported surgical date and if additional information is received, a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0a6sn, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ab21, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102298
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dennis100
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« Reply #181 on: October 12, 2014, 06:21:12 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v526048, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
It was reported that a patient was hospitalized for 6 months because her lungs/diaphragm stopped working. One was frozen and the other wasn¿t moving at all. After the patient had the deep brain stimulator (dbs) put in, she started having trouble swallowing, her voice changed, and she was choking all the time. While the patient was in the intensive care unit (icu) her dbs batteries went out. A couple of weeks after the battery went out, her throat started getting better- everyone said ¿you sound wonderful¿. The patient wondered ¿if the dbs affected her throat, could it also have affected her diaphragm¿. The patient was breathing out of the top 1-2 inches of her lungs. After about 3 minutes of standing, the patient would be gasping for air. She is on oxygen ¿24/7¿. The patient had organizing pneumonia and within 2 weeks it was ¿so acute¿. A biopsy was attempted, but it was unknown what the patient had, how she got it, or how to fix it and they haven¿t been able to help her at all. The patient¿s tremors were ¿so bad now¿. When the patient¿s dbs devices were put in, they were affecting her thoughts and she was having trouble saying the right words. When the patient would want to say (b)(6) it would come out (b)(6). When her thoughts would come out, they weren¿t organized. Since the batteries went dead, she can think and say the right words. No interventions or outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. A follow-up report will be submitted when more information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096816
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dennis100
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« Reply #182 on: November 07, 2014, 10:51:22 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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dennis100
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« Reply #183 on: November 07, 2014, 10:52:28 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported with the patient¿s first implantable neurostimulator (ins) batteries, the first time the therapy was turned on was in (b)(6). When the therapy was turned on they could not speak and they were reprogrammed 2 times to resolve the issue. They feared that it would happen again and they only wanted to turn the therapy on with the manufacturer representative present. The ins was replaced on (b)(6) 2014 because the previous battery didn¿t function. 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 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3387s-40, lot# va0j9k0, implanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# va0j9k0, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4). F. 10. Patient codes : c35546 device codes : c62955 medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned". These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210473
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dennis100
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« Reply #184 on: November 08, 2014, 03:41:40 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3387-40, serial # (b)(4), implanted: (b)(6) 2012, product type lead; product id 3387-40, serial # unknown, implanted: (b)(6) 2012, product type lead. (b)(4).

Event Description
It was reported the patient had two new leads implanted on (b)(6) 2012 because the target of the patient¿s initial two leads ¿was not accurate. ¿ because the patient had ¿brain edema¿ at the time however, the initial two leads ¿were not explanted¿ at the time of implant of the two new leads. While the patient had ¿spoken normally¿ following the initial implant of their device system in (b)(6) 2011, the patient ¿couldn¿t speak¿ after the 2012 implant procedure. The patient¿s doctor reportedly ¿said the symptom was caused by brain edema. ¿ the patient was ¿anxious¿ and she ¿spoke unclearly¿ at the time of report, however ¿she had no trembling and rigidity problem¿ at that time. It was noted the patient¿s implantable neurostimulator ¿battery was low¿ at the time of report and remained implanted. It was ¿unknown¿ whether any troubleshooting had been performed or what the patient¿s outcome was following the report. Additional information has been requested. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4174577
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dennis100
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« Reply #185 on: November 08, 2014, 04:33:54 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0357358v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0340483v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. (b)(4).

Event Description
It was reported that one time the device turned off within the last 2 years prior to the date of this report and the patient was sent to the hospital due to the fact the he got to the point where he could not move, walk or talk, was diaphoretic and his blood pressure went up. This had not been within the last year prior to the date of this report, so it had happened prior to the last year. No interventions or outcome were reported. 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=4156403
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dennis100
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« Reply #186 on: December 06, 2014, 12:24:07 AM »

Model Number 3389-28
Event Date 08/27/2014
Event Type Injury
Event Description
It was reported that the lead implant procedure took place on (b)(6) 2014. On (b)(6) 2014 the patient developed a confusional state with apathy and mutism. No hemorrhage was detected on the head ct scan. The patient¿s hospitalization was prolonged. The reporter considered the event related to the leads. The reporter confirmed that the confusional state was due to local cerebral edema following the lead implantation, with effect of partial thalamotomy. No actions were taken. The event was resolved without sequelae on (b)(6) 2014. After implantation of implantable neurostimulator (ins) the patient experienced transient aggressiveness due to general anesthesia. The patient received atarax, one ampule. The event resolved without sequelae on the same day. Refer to manufacturer report number 6000153-2014-00191.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4241152
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dennis100
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« Reply #187 on: January 10, 2015, 03:20:50 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient had unilateral lead placement to control tremor with good response initially. It had been observed that after 4 to 6 weeks, the patient experienced ¿rapid habituation¿ of the current, and their tremor returned within 4 days and it was ¿to the same extent that it was prior to the device¿ but ¿not as bad as the refractory tremor. ¿ this had reportedly been a ¿constant cycle¿ and became a concern as the patient reached 6v in bipolar mode and "bordered on" the patient experiencing a ¿capsular effect. ¿ this ¿capsular effect¿ was clarified to mean ¿voice, speech, double vision as well as a hot and cold sensation. ¿ other experiences that had increased since having the device included tremor, inbalance, headache, arm aching, ¿clammy hands¿, contracture of the hand, exhaustion from tremor and inability to hold cutlery. It was also noted that when the patient¿s device was turned off, he had a ¿severe¿ refractory tremor, far worse than it was prior to the device. This was ¿so violent¿ that it could only be turned off for a minute. There had been no falls or trauma prior to noticing this. The physician feared that it could be morphology of the disease. The reporter indicated that initial thresholding was done but electrode configuration had remained the same at a setting of 90's, 130 hz on electrode pair 0-,1+. The amplitude had been increased from 2. 2v to 6. 4 in several increments. Threshold testing had been performed again, but to no avail. All electrode and therapy impedances were normal for all testing done with the patient in a rested position, arms up and head to the side. Additionally, no error messages had been observed on either the clinician or patient programmers. The patient was admitted to the hospital for further tests and was placed on constant current mode at 4. 6a under observation. A ct scan was performed which showed ¿perfect lead placement within the proposed target. ¿ the patient had also undergone ¿some more testing¿, details of which were not available at the time of the report. The patient had however not had any ¿positive change¿ yet. Discussions about the possibility of creating a "lesion effect" with the lead were underway. The reporter stated that the implantable neurostimulator (ins) was going to be replaced. If additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative
Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3387-40, lot # 0208456401, implanted: (b)(6) 2014, product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334699
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dennis100
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« Reply #188 on: January 10, 2015, 04:52:17 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that when the patient had woken up in recovery on (b)(6) 2014 after the deep brain stimulator implant they had vision, balance and speech problems on their right side. The patient had nothing but problems with the left implantable neurostimulator (ins). The side that controlled the patient¿s left arm worked well in controlling the tremors, but the side the controlled the right arm was giving him trouble. The patient could not move his eyes which contributed to his movement and instability problems. The patient was also agitated and weak and used a walker. The patient used a walker full time now and they were not doing well. Two years prior to this report the patient was very active and they could not do anything at the time of this report. When the patient¿s right side was turned on the reporter could not understand what the patient was saying. The patient was looking into having the inss removed. The patient had spoken to their healthcare professional (hcp) who thought they could take the ins out and leave the wires and electrodes in place, but they did not want to do that. The patient¿s vision, balance, and speech were affected in the recovery room after implant and the hcp stated they had problems finding a spot that it would not affect. The patient did not have any problems going into surgery. In the recovery room the patient¿s speech was altered and their eyes were fixed at the ceiling so a ct scan was ordered because the hcp thought the patient had a stroke. In (b)(6) the patient went back to their hcp and they tried reprogramming five times, but the patient¿s symptoms got worse. The patient waited for the swelling to go down and the symptoms to resolve, but it¿s now december and the patient still had problems. The reporter thought the wires and electrodes caused the problem and removing them did not guarantee the problem would go away. The reporter stated the hcp told them they had to do more than one tunnel to find the right spot. The reporter further stated they wanted to know why the patient could not have all of the leads taken out. The hcp stated they were willing to remove the ins in about three weeks after this report. 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 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va0jlr4, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326957
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dennis100
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« Reply #189 on: February 07, 2015, 07:20:00 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had thought the deep brain stimulator would have a positive effect on the quality of life but it had been the opposite. The patient had first had surgery to help the right side tremor and it had gone well so they decided to have the left side done which was in (b)(6) 2013. That was when the problems had started and they had not stopped. Side effects impacted the patient¿s balance and speech which eventually lead to the patient falling. Following a series of tests they found out the patient had a brain infection. The patient spent time in the hospital getting treated for the infection and was still trying to get ¿c. Diff¿ under control. It was noted that it had been one thing after another and the patient had believed it all started with the frayed wire. The patient was still doing out patient rehab to help with balance and speech but the patient had been told speech would not get much better. The patient was concerned not much would get better. It had been a disaster. There were serious side effects that would impact the patient¿s family and him the rest of his life. 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.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0bh3r, implanted: (b)(6) 2014, product type: lead, product id: 3387s-40, lot# va0b0xv, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, 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=4460634
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« Reply #190 on: February 07, 2015, 12:14:02 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 #191 on: March 07, 2015, 05:00:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 01/26/2015
Event Type Injury
Event Description
It was reported that after the lead was implanted the patient had "temporary parenthesis" and speech arrest. The patient¿s healthcare professional (hcp) decided to remove the electrode and take a trans-operative ct scan. The ct scan showed that the patient suffered an intraparenchymal hemorrhage. At the time of this report the patient was in the intensive care unit. The patient already had a deep brain stimulation system and they were having the lead revised. 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: 3387-40, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4523791
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« Reply #192 on: April 19, 2015, 02:50:44 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that when the patient¿s second side was started, their moth froze and they were not able to talk. The lead was taken out and implant had to be rescheduled. The patient stated that they were only able to put one side in, not both, and they had to go back twice in surgery to put the other side in. The patient further stated someone was being sent out today, but they were not sure if it was a nurse or manufacturing representative. Follow up with the patient indicated that they did not have concerns with their device or therapy.

Manufacturer Narrative
Concomitant: product id 37603, serial# (b)(4), implanted: 2015-(b)(6), product type implantable neurostimulator. Product id 3708640, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3387s-40, lot# va0kc0b, implanted: 2015-(b)(6), product type lead. Product id 37642, serial# (b)(4), product type programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4592156
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« Reply #193 on: April 19, 2015, 02:51:34 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was an infection at the lead location. It was unknown what type of infection or if a culture was taken. It was unknown if antibiotic treatment was necessary. The entire system was explanted due to the infection. There was no alleged product issue. Additional information received indicated that they believed perioperative antibiotics were administered. It was unknown if the patient had meningitis. It was also unknown what treatment was instituted for the infection or what the patient outcome was. The patient had presented with slurred speech. All cultures had come back negative. Upon explant, one of the leads had edema throughout the entire ¿brain¿ section of the lead with more around the cortical end. The healthcare professional was wondering if there was some type of chemical on the lead that elicits a reaction at the implanted site and created an abnormal amount of edema causing a complication. Healthcare professional inquired about using a gas chromatograph on the explanted lead as part of analysis. 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.

Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type extension product id 3387s-40, lot# va0j2e8, implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4643373
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« Reply #194 on: April 19, 2015, 02:52:10 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient¿s second implant had been implanted in the right side chest for the left side of the body in (b)(6) 2014 and it was not working. The patient had a lead replacement on (b)(6) 2014 because it had not stopped the tremors and the patient was unable to talk. The reason for the lead replacement was because they had thought the lead was initially placed incorrectly. The lead replacement had not made any difference to her symptoms. The healthcare professional was aware of the symptoms and the patient was scheduled to see him on friday following the date of this report. The patient was also going for some speech therapy on april 1st due to not being able to talk and talking on the phone was a chore. The patient¿s original implant that they had in 2011 had worked perfectly and she had never had any problems but the one from (b)(6) 2014 had not been good since day one. The patient had tremors since the 2nd system implant in (b)(6) 2014. The patient had never had a speech problem prior to the deep brain stimulator implant, they had turned it up to get her left side to stop shaking partially and that was when the speech problems had started; soon after the surgery in (b)(6) 2014. The manufacturing representative had tried to change it and he was unable too, nothing worked and this had been in march or april prior to the date of this report. It was noted that the manufacturing representative had no knowledge of any concerns. No outcome was provided. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id 748351, lot# nhu241291v, implanted: (b)(6) 2014, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0f2fu, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# va0l4l4, implanted: (b)(6) 2014, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4636047
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« Reply #195 on: April 19, 2015, 02:52:48 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# va0b8hm, implanted: 2013 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# va0b8hm, implanted: 2013 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3387s-40, lot# va0b8hm, implanted: 2013 (b)(6); product type lead. (b)(4).

Event Description
It was reported, the patient had a lead revision approximately four weeks prior to this report. The patient¿s healthcare professional (hcp) wanted the implant left off for four weeks after implant, but a nurse had turned the implantable neurostimulator (ins) on. The patient had complications from the revision surgery and they had difficulty with speech and resting tremor at the time of this report. The inss were turned on prematurely to help control tremors. The patient was in a rehabilitation center for recovery and their prognosis was day to day. The manufacturing representative stated the patient¿s issues were not so much from the ins, but from complications from the surgery. No outcome was 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. Refer to manufacturer report #3004209178-2015-05486.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4636007
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« Reply #196 on: May 09, 2015, 03:04:33 AM »

Model Number 37612
Event Date 03/25/2015
Event Type Injury
Event Description
It was reported that the patient¿s neurologist called the manufacturer representative (rep) and asked which x-rays would provide the best image of the implantable neurostimulator (ins), extensions, and leads. The patient self-admitted to the emergency room (er) the morning of the report; he had pain on the right side of the neck and a return of symptoms, including speech degradation and a change in gait. It was considered a sudden loss of stimulation and therapeutic effect. The ins was checked by the neurologist using a clinician programmer and it appeared to be on without any problems. The patient was hospitalized due to the event and was referred back to the original implanting physician for evaluation. No surgical interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 64002, lot # n248030, implanted: (b)(6) 2010, product type adapter; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v050963, implanted: (b)(6) 2007, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4693815
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« Reply #197 on: June 08, 2015, 06:48:36 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Additional information received reported that the patient¿s behavioral changes, speaking and choking had nothing to do with their deep brain stimulator. It was noted that it was being handled in a different manner.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported that in order to control the patient¿s parkinson¿s disease tremors stimulation had to be turned up high but that resulted in the patient barely being able to speak. The patient slurred like he was drunk and had choking issues. The patient was never able to go off medication as he had been promise prior to surgery. The patient had changes in behavior after surgery also. The healthcare professional had been treating the patient for depression as well. It was noted that the patient had lost his job after surgery and the patient¿s father had bipolar issues. The deep brain surgery had been in 2010. The patient¿s wife was concerned about the patient¿s safety. The patient had depression since the original implant, he was on 2 depression medications which had made him suicidal. The depression continually gets worse each time they had increased the 2 oral medications. The patient had also developed behavioral changes which included obsessive compulsive disorder, hermit, reclusive, paranoia, delusions, insensitive, no filter when he speaks to people, domineering, rage issues especially when driving, and violence. The patient has also broken things and broken his own ribs in one of his rage fits while breaking things. The patient was aggressive with his children. The patient had moved out of the house and would not speak to his wife. The patient had always been loving, kind and respectful but all that had gradually begun to change since the deep brain stimulator was originally implanted but specifically when oral depression medication was introduced. Reference manufacturer¿s report number: 3004209178-2015-08285 for patient¿s current system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4742823
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« Reply #198 on: June 08, 2015, 06:49:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the patient ¿seemed sleepy, struggled to open his eyes,¿ had slowed and mumbled speech, and increased tremor frequency and severity. The patient was ¿in intensive care¿ at the time of report. The patient¿s physician indicated ¿the patient had a hemorrhage at the lead tip and at the entry point of the lead. ¿ it was unknown when the event had occurred; however, the issue was noted to have been found on a post-operative ct scan that was performed either the afternoon of or morning after implant. It was noted there were ¿no vessels¿ found during ¿stealth¿ imagine in either location. The cause of the issue remained undetermined at the time of report. The patient was alive ¿with injury¿ and had ¿no improvement¿ in their symptoms at the time of initial report. Some reprogramming was performed with the patient as a result, though ¿no clinically significant benefit¿ had been attained as of three days after initial report. The patient was ¿unwell¿ and continued to have ¿slurred speech, poor eyes, and bad tremor¿ as of three days after initial report. It was stated the ¿true benefit was unknown¿ at that time. It was "unknown" whether any interventions had been required due to the event. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant product: product id 3389-40, lot # va0pc08, implanted: (b)(6) 2015, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4749095
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« Reply #199 on: June 08, 2015, 06:50:35 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient was left in a nursing home, worse off. Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home. The patient could barely feed himself. The patient had gone through the surgery wide awake ¿like a trooper. ¿ it had all gone downhill about 2 months after the deep brain stimulator surgery. The patient had good progress after the surgery for a week to a week and a half or two weeks. The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home. The patient could not talk , walk or feed himself. The patient¿s system was checked two years prior to the date of this report. Patient¿s status was unknown. Reprogramming had been tried. The patient had been his healthcare professional¿s and still could not walk or talk.

Manufacturer Narrative

Event Description
It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast. The patient could not text.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead. Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, 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. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762647
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« Reply #200 on: June 08, 2015, 06:51:27 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported the patient was going to have a revision to remove the left ¿probe¿ next thursday. The lead is being removed because the patient lost all ability to swallow and speak and they had been on a feeding tube for eight months. The reporter stated the lead was not in the wrong spot, but it just was not where the patient¿s healthcare professional (hcp) put them. A new lead was to be implanted about a month after the lead was removed. No outcome was 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802718
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« Reply #201 on: June 08, 2015, 06:52:46 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient had chest pain, a loss of effect, and a lack of symptom control since the replacement of their implantable neurostimulators (ins). The patient had been having slurred speech and issues with controlling their tongue. On the day prior to this report, the patient had bit their tongue bad, which had made their speech even worse. The patient¿s jaw was tight and they almost broke a tooth. Every time the patient had their ins replaced, it took them three months to get the ins properly adjusted and for them to receive any benefit. The patient also had an increase in rigidity and dystonia in their neck and extremities with their left being worse than the right. The patient met with their healthcare professional (hcp) a day prior to this report because their pain was so bad they thought they were having a heart attack. The pain was located in the patient¿s chest near the ins and in their armpits. An x-ray was done and the patient was going to follow up with their cardiologist. The patient was evaluated by their cardiologist and cardiac etiology was ruled out. Impedances were checked and one of the contacts was not being used. Impedances of electrode zero were measured to be greater than 40,000 ohms on the left side. The left ins was programmed to 2-, 3+ at 4. 7v, 90 usec, and 145 hz. Impedances of electrode three were measured to be greater than 40 ,000 ohms on the right side. The right ins was programmed to 1+, 2- at 4. 2v, 90 usec, and 145 hz. Therapy impedances were measured to be within normal limits on both sides. The patient¿s hcp planned on reprogramming the ins to get efficacy. The cause of the event was not determined. A troubleshooting revision had been scheduled for (b)(6) 2015 due to the high impedances. During the revision, the hcp opened the right incision and noticed the bottom two screws on the ins were not tightened. The hcp loosened all four screws, dried off the extension, and retightened everything. The right side bottom connector for the ins and extension still seemed not tight and there was a small gap, but everything was tightened down. Impedances were then tested and all impedances were within normal limits. The same issue occurred when the left side incision was opened. After the revision, all impedances were within normal limits on both sides and no further troubleshooting was done. Refer to manufacturer report #3004209178-2015-09832.

Manufacturer Narrative
Concomitant products: product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v443426, implanted: (b)(6) 2010, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802318
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« Reply #202 on: July 16, 2015, 12:19:17 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v239714, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v279715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
It was reported the patient went to have an electrocardiogram (ecg) done in (b)(6) 2015 and prior to the ecg the cardiologist passed a magnet over the patient¿s pacemaker. The patient immediately began having seizure like movement called dystonic. The patient had drooping on one side of their face and the face was distorted, their speech was allured, and their right hand tightened and twisted, and their handwriting was affected on the right side. The slurred speech and the patient¿s face sagging lasted for about an hour. The patient was admitted to the hospital and they spent the night there for observation. Since the ecg, the patient had been tired and they were very anxious about having anything done to the pacemaker. The reporter stated the ¿seizure thing¿ was brief and stopped soon, the drooping in the face continued for a couple weeks, and the patient¿s hand writing gradually got better. In the past, the patient has had ecgs without interference. Since the patient last saw their healthcare professional (hcp) in 2010, they had not turned their devices off or made any adjustments to settings. Someone in the patient¿s assisted living center checks the devices with the patient programmer and last fall they could not get it to work so they stopped checking it. The patient was checked by their neurologist and they said the patient had dystonia. The hcp was not sure why this happened. The hcp thought the patient¿s implantable neurostimulators (ins) should be depleted by now, but the devices were tested and they were working, but low. The patient had not had a return of tremor so they did not see their hcp until now. The ins was on and working well. The ins battery was low at 2. 29v and the patient programmer did not show any lights indicating the battery was low. Impedances were measured to be normal. If the patient¿s tremor returned, they were going to schedule an appointment to have the ins replaced. The patient was about to have another ecg again and the nurse stated they could try turning the ins off and then back on. The nurse also mentioned using a pie plate to shield the magnet from the device. The patient did not have the symptoms of tremors before. The patient¿s hcp later reported the patient had a 50 percent or greater symptom reduction and they had recovered without permanent impairment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4870903
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« Reply #203 on: August 08, 2015, 10:05:23 AM »

Model Number 37612
Event Date 06/20/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that on (b)(6) 2015, the patient became inarticulate and had leg muscle stiffness. Reprogramming was done in (b)(6) 2015 and the patient¿s healthcare professional (hcp) turned stimulation up to 2. 5v from 2. 0v, but there was no symptom improvement. The cause of the event was not determined. The patient wanted to know if there are any better solutions. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949605
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« Reply #204 on: August 08, 2015, 10:06:02 AM »

Model Number 7428
Event Date 06/17/2015
Event Type Injury
Event Description
It was reported that 48 hours ago the patient was going through airport security and he passed through a medical detector. After passing through the patient sat near a security archway for about 15 minutes and then was required to pass through again. The patient was hospitalized, and had gone from a fully functional brain to now not able to hold a thought; he was unable to make a sentence and does not know where he is. The patient¿s wife described the patient¿s dementia as off the chart. The patient was incoherent and has been strapped down for safety. The patient¿s device was confirmed to be on, but the settings were unknown. Loss of therapy was reported. The patient¿s wife was trying to get a hold of the patient¿s implant doctor, but the doctor was currently away; she was going to try to get the patient transferred to his city. Follow up was performed but no additional information was available. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4900086
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« Reply #205 on: August 08, 2015, 10:06:38 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient had a throat issue since implant. During surgery or programming of the patient¿s implant in 2007 something happened and it had caused the patient¿s palate to not be able to close; it got the palate in his throat. As a result the patient could not talk and breathe at the same time. The patient could not speak well and could not be understood. The patient had 5 surgeries to fix the problem but it was not resolved. The 5 surgeries were on the patient¿s throat and now they were trying to help the patient with his speech but neither had worked. The patient¿s last surgery on (b)(6) prior to the date of this report a skin graft was used but that had not worked either. This was occurring daily. Reference manufacturer¿s report numbers: 6000153-2006-02427 and 2182207-2006-02428 for patient¿s previously implanted systems.

Manufacturer Narrative
Concomitant products: product id neu_unknown_lead, lot # unknown, implanted: (b)(6) 2005, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2010, product type implantable neurostimulator; product id 7426, serial # (b)(4), implanted: (b)(6) 2006, product type implantable neurostimulator; product id 3387s-40, lot # v012713, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4934777
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« Reply #206 on: August 08, 2015, 10:07:17 AM »

Model Number 3387-28
Event Date 04/09/2015
Event Type Injury
Event Description
It was reported that there was a subcortical hematoma on the frontal left lead trajectory during the procedure. Symptoms included dysarthria and language trouble at testing phase. It was unknown what had led to this event. Diagnostics included imaging with abnormal results of subcortical hematoma on frontal left lead trajectory. Interventions included interrupting the procedure. The left lead remained implanted and the right lead was not implanted. The issue was resolved. This was procedure related. The outcome was resolved without sequelae.

Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4957760

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« Reply #207 on: September 07, 2015, 07:24:06 AM »

Model Number 37603
Event Date 09/06/2011
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v750613, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
The consumer reported that her device was off at the time of the report as it was not helping her. The patient planned to go to her doctor the week after the report to get it looked at. Additional information from the consumer reported she had many concerns- side effects etc. As of (b)(6) 2011, her concerns were not resolved. The patient still had concerns regarding her device and therapy but she was working with her doctor/ manufacturer's representative. An appointment was set for (b)(6) 2012. The patient went in for her appointment and the device was interrogated by the hcp. The device was turned off on (b)(6) 2012 for mri. She had not been using the system due to poor tremor control. The patient was scheduled for surgery on (b)(6) 2012 for 2nd gpi lead replacement/ revision, a manufacturer's representative was to be present at the surgery. The first lead at the ventral intermediate nucleus (vim) was not enough to control tremor; the second vim lead was placed with the primary cell (pc), dual battery. The tremor was under control, the outcome was great. The patient never had therapeutic effect, she had tremors in her right hand and head, poor speech and her balance was off. There was speech decrease and poor lead placement. The first lead that was put in didn't work so well so the doctor put in another one. It was noted that the patient had 1 lead placed in the left side of the brain then the other lead was placed next to that lead because of lead placement. The patient had two leads in the same hemisphere/ target area for tremor control. The hcp initially went to insert a 2nd probe into the subthalamic nucleus but when they were doing the procedure; the hcp realized it was not having any effect on the tremors. They decided to reinsert another probe into the same nucleus at first. The 2nd probe was giving 70-80% relief from the tremors in her right hand. No further information was reported. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004132
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« Reply #208 on: September 07, 2015, 07:25:02 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(6) nkn052270v, implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
A consumer reported that they got sick between the lead implant and implantable neurostimulator (ins) implant surgeries and they were in the hospital for 4-5 days. After the patient was implanted with the leads they noticed some issues with the patient's speech and walking, which were slowly going away. The patient's speech had been worse since implant. The patient's health care provider (hcp) checked them and they did not have a stroke. The hcp concluded that the issue may be from swelling. When the ins was turned on, they did not notice the ins much, but they were noticing some of their symptoms coming back. A manufacturing representative told the patient that they could turn the ins off when needed if their speech was bad. No outcome was reported regarding this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4991318
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« Reply #209 on: September 07, 2015, 07:26:05 AM »

Model Number 37601
Event Date 07/20/2015
Event Type Malfunction
Event Description
Information was received from another source that reported the patient went to see his health care professional (hcp) and was exposed to some sort of test/environment where he lost the ability to speak. There was emi environmental exposure. The patient had a loss of speech. The patient was implanted for parkinson铠dual and movement disorders. Further follow-up is being conducted to determine what steps were taken to resolve the loss of speech. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant: product id 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type extension. Product id 3389s-40, lot# va0uvrw, implanted: 2015-(b)(6), product type lead. Product id 3389s-40, lot# va0w5ce, implanted: 2015-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4992995
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