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Author Topic: Deep brain stimulator - Gastrointestinal  (Read 5941 times)
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dennis100
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« on: January 14, 2014, 12:42:34 PM »

Model Number 7426
Device Problem Replace
Event Date 04/15/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The implantable neurostimulator and extension were returned for analysis. No anomaly was found during final device analysis of the implantable neurostimulator. The extension was cut through (explant damage suspected); no significant anomalies were found otherwise.

 
Event Description
The pt had surgery to replace his right-sided implantable neurostimulator. The new device was implanted in the abdomen because the pt had a pacemaker implanted as well. The pt had abdominal stimulation. Symptoms included diarrhea, abdominal pain and 'bowel symptoms' when stimulation was turned on. The generator and extension were replaced in 2008, and the pt did not experience abdominal discomfort when the new stimulator was turned on. The pt's symptoms resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1075472
« Last Edit: September 07, 2015, 06:38:59 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 14, 2014, 12:43:39 PM »

Model Number 7426
Device Problems Device remains implanted; Unit inactivated
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported, following implant, the patient experienced a lack of effect, acute pain in the face, and nausea. The patient had the ipg devices on for one day with good results. Following the first programming the patient then began experiencing the pain in the face and neck (also described as a painful tingling sensation on the face (cheek, nose and eye areas). The patient also experienced sensitivity to light and noise, a pulling sensation on her neck, and pain from the wire in her neck and the ipg in her chest. Reportedly, the worst symptom was the severe nausea. When the device was turned on, the nausea built up over time. The patient experienced dry-heaving and became dehydrated due to not eating or drinking. The patient was hospitalized for a few days (date unknown) to be evaluated for infection. The patient did not have an infection. The patient was prescribed steroids which did help some. The patient had her device turned off due to the return of symptoms when turned on. See mfr report #3004209178200804484. Additional information has been requested, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083478
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dennis100
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« Reply #2 on: January 14, 2014, 01:50:13 PM »

Model Number 3387
Device Problem Device remains implanted
Event Date 11/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported the patient status one-day post dbs revision; interrogation of the left-sided system had revealed one impedance value remained less than 50 ohms. The interrogation numbers obtained were: electrode impedance 646, 654, 850, 789, <50, 1076, 1058; other values were deemed to be within normal limits. The left-battery impedance was 927 with current of 29, and battery voltage was 3. 74, the battery "was reading ok. " the patient electrode settings were 3+, 0-, amplitude was 1. 8, pulse width was 90, and pulse rate was 130. When the hcp "tried to go higher on his amplitude the right-side of his face went numb, and his ability to speak decreased. " the pulse width and pulse rate were turned down to the settings listed above, but they "could not go any higher on the amplitude without getting side effects. " the patient stated he was comfortable at the prior settings and his right arm tremor was gone. He had not taken any medications since the previous evening and the patient was discharged to home (nursing home), in 2007. At follow-up the following month, the patient reported he felt "the same" and was tired; he had continued to work with physical therapy and had felt stronger. The patient could "walk about 5 steps before his legs give out. " there had been no falls or syncope symptoms subsequent to hospital discharge. The patient had turned dbs therapy off; he attributed increased weakness and diarrhea, including the loss of bowel control to the devices. He had the onset of gastrointestinal upset and diarrhea within 2-3 hours when stimulation is turned on that resolved when therapy is turned off. The patient had "repeated this scenario with consistent results, unable to use dbs implant," the patient had left stimulation off to avoid the affects of diarrhea. On the same day, (visit notes continued): the patient continued with right-sided tremor, symptoms were greater in the right-hand than the leg; the patient reported "trouble turning in at night. " he was eating and drinking well and had used lortab for right-hip and back pain with good relief. Results of physical exam had shown the patient was well-groomed, well-nourished in no acute distress; his attention span and concentration were normal and in no acute distress; his attention span and concentration were normal and appropriate for his age and education level. The patient's speech had been clear, his smile was deemed symmetrical and intact. There was right-upper extremity resting tremor, they were unable to test gait. The patient would continue with current medications, he would take rozerem every night. At follow-up five days later, the dbs therapy had remained off due to uncomfortable bowel movements. The patient had indicated that he had not experienced uncontrollable bowel movements subsequent to turning off stimulation therapy. It was also "noted that before this battery change he was up and walking, but is now in a wheelchair, and he stated that his legs felt like rubber. " the hcp indicated that the patient had been programmed until right-facial pulling was detected and the patient reported tingling in his right-hand and right-foot; "it was very difficult to turn up any of the controls because he would get right facial pull and tingling in his right hand and foot. " system adjustments were reported as: electrode settings, 3+, 0-, amplitude 1. 6, pulse with 90, pulse rate 100. Impedance readings were 868, 881, 1022, 1049, <50, 1227, 1424, 1227, 1441, 1239. Battery impedance was 1132, current 25, battery voltage was 3. 75, the reading was "ok. " the sinemet cr 50/200 medication was increased to twelve tablets daily; all other medications remained unchanged. The next day, the patient was seen at the clinic for suture removal from the scalp post-replacement of the left-sided extension; the incision had been well-healed, the sutures had been removed without difficulty. The patient was seen for follow-up the following month, visit notes had been unavailable. The patient would be referred for further evaluation of the dbs system and would be referred to the neurosurgeon, if needed. The patient outcome had been reported as non-serious illness or injury related to gi symptoms of diarrhea. Refer to mfr reports #6000153200704467, #2182207200800451, #2182207200800452, #6000153200800453, #2182207200800454.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989147
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dennis100
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« Reply #3 on: January 17, 2014, 12:42:11 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced brain edema, "one side of the body locked up" and nausea/dry heaves. The patient did not feel he received adequate follow-up after implant. Additional information has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer report #3004209178-2009-00231.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287243
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dennis100
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« Reply #4 on: January 17, 2014, 09:23:24 PM »

Model Number 7426
Device Problem Explanted
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's device was removed due to infection. The patient symptoms were reported to be drainage, pain, headache, seizure (occurred 2008, with head trauma), nausea, vomiting, and fatigue. The primary location of the infection was the lead track; the patient did not have meningitis. A culture was taken (date not reported) and revealed serratia marcescens; staph coagulase negative. The patient was administered perioperative antibiotics and the infection was treated with iv and oral antibiotics. The infections resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1317789
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dennis100
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« Reply #5 on: January 17, 2014, 09:25:01 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/20/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
Following a fall where the patient hit her head, the patient experienced a loss of therapeutic effect, nausea, dyskinesias, and speech issues. When the battery lights were assessed, the middle light did not come on for either implantable neurostimulator (ins). The patient was at home and her status was reported to be "fair". The patient was encouraged to contact her healthcare professional. Additional information has been requested, a follow-up report will be sent if additional information becomes available. Also see manufacturer's report # 3004209178-2009-02032.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387855
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dennis100
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« Reply #6 on: January 18, 2014, 02:11:45 PM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced nausea and vertigo when the patient was being positioned for a diagnostic ultrasound. The machine was on at the time. When the patient sat up she felt better. When the patient lied back down, with the machine off, she did not feel nausea or vertigo. The stimulation was on the entire time and never shut off during the course of the event. The patient had experienced previous episodes of vertigo at home, thought the exact nature of the incident was not clear. Additional information has been requested, but was not available as of the date of this report. Reference mfr report # 3004209178200903488.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1433006
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dennis100
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« Reply #7 on: January 20, 2014, 01:15:06 PM »

Model Number 7426
Device Problem Device remains implanted
Event Date 05/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
It was reported that the patient had nausea for five weeks, and was hospitalized for five days. The patient's implantable neurostimulator had been on, except for being turned off for ekgs. Additional information has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer's report #3004209178200905223.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1423561
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dennis100
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« Reply #8 on: January 23, 2014, 07:37:11 AM »

Model Number IPG
Device Problems Electro-magnetic interference (EMI); Electronic property issue
Event Date 02/28/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Event Description
Literature: chen c, cole w, bronte-stewart hm. Hybrid cars may interfere with implanted deep brain stimulators. Mov discord. Nov 15 2009;24(15):2290-2291. Summary: this was a case report of a (b)(6) man with a history of tremor dominant parkinson's disease (pd) who underwent bilateral subthalamic nucleus dbs placement and later experienced suspected interference with his hybrid car. Event: a (b)(6) man with history of tremor-dominant parkinson's disease (pd) underwent bilateral subthalamic nucleus deep brain stimulator (stn dbs) placement. One month later, initial stimulator programming was performed, and he complained of symptoms of severe nausea, dizziness, and palpitations while driving the 4- to 5-hour journey home in a 2008 hybrid toyota prius car. The patient's wife had to stop the car multiple times as he felt so ill. Prior to initial programming, the patient was able to drive and ride in the prius without any problems. After stimulator activation, the patient complained of reproducible symptoms of nausea, dizziness, lightheadedness, and cardiac palpitations when sitting in the front passenger seat. He noticed that the symptoms worsened when both the gasoline engine and electric motor were running or when the car battery was charging. The symptoms spontaneously resolved when he exited the car and never occurred when he was in his truck, which is a non-hybrid vehicle. The symptoms also improved when he manually turned off his stimulator while inside the prius or when he moved to the back seat. These symptoms did not occur at any other time. On interrogation of his stimulator 4 weeks after the initial dbs programming, seven activations were noted with only two that were accounted by the patient turning the pulse generator off and on manually. The internal pulse generators (ipgs), however, had been on 99% of the time. The patient experienced the worst symptoms when sitting in the front seat of the prius and when the car battery was being charged, suggesting that the electromagnetic field emitted might be interfering with his neurostimulator settings. There were multiple unaccounted activations on interrogation of the stimulator, although the ipgs were on 99% of the time. He did not get symptoms in a non-hybrid car or in the prius when his ipg was off. We have observed similar symptoms when the voltage of an stn neurostimulator was increased rapidly. We hypothesize that the device was turning off and on rapidly, with voltage surges, thus causing the patient's symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658648
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dennis100
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« Reply #9 on: January 26, 2014, 02:32:24 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 07/08/2010
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: gruber d, kuhn aa, shoenecker t, et al. Pallidal and thalamic deep brain stimulation in myoclonus-dystonia. Mov disord. Aug 15 2010; 25(11):1733-1743. Summary: the authors investigated short- and long term effects on motor function, cognition, affective state, and quality of life (qol) of gpi- and vim-dbs in myoclonus-dystonia (md). Ten md patients were evaluated pre- and post-surgery between 1997 and 2009. Both gpi- and vim-dbs are effective. There were fewer adverse, stimulation induced events with gpi-dbs in comparison with vim-dbs. There were 18 reversible stimulation-dependent adverse events (ae) in the vim group which resolved by adaptation of parameters; these include dysarthria, dysphagia, dysgeusia, worsening dystonia, headache, gait disturbance, dysaesthesias. There were 4 events experienced by the gpi group; these were nausea and phosphene. It was unclear which patients experienced which adverse event; however, no serious long-lasting stimulation-related ae's were observed. Reportable event: patient 8 of 10 received bilateral gpi and vim-electrodes; this patient experienced a reversible intracerebral hemorrhage less than or equal to 3 month's hemiparesis. The source literature did not specify which device models were used for the different patients. See literature article with mfr report# 3007566237201007967.

 
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. It is also possible, several events occurred in one patient. At this time, no additional information was available, additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872749
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dennis100
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« Reply #10 on: January 27, 2014, 08:33:17 AM »

Model Number 37601
Event Date 08/12/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported after surgery the patient reported headaches, nausea, and vomiting. The patient hospitalized for an extra day. Following treatment with anti-emetic and pain medications the patient recovered satisfactorily and was discharged.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528594
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dennis100
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« Reply #11 on: January 27, 2014, 09:43:20 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va02wws, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

 
Event Description
It was reported that the patient experienced a pull in her neck the day of the report and left sided neck pain. The patient stated it could be related to the implant. The patient had intermittent neck pain which worsened. The patient was to have an x-ray to visualize the skull, neck and chest to look for kinked wires or anything abnormal. It was further reported that the patient was at the emergency room on the day of the report and was having problems. The patient had head and shoulder pain and felt ¿loopy¿ and nauseated. The symptoms had been coming and going but the start date was unknown. There were no falls or traumas. It was stated that the patient¿s husband thought the er visit was related to the device because she had never felt this way before. Additional information noted the patient was scheduled to meet with her healthcare provider (hcp) on (b)(6) 2013. Additional information stated the patient could feel the wire in her neck. It was noted the patient had first noticed this a ¿little while¿ prior to follow-up. It was stated there were no known accidents or incidents related to this condition. Additional information reported the patient was not feeling her stimulation ¿like she should be¿ and that she was not ¿feeling it as well. ¿ it was noted this had occurred for the month prior to follow-up. The patient reported her hcp was about to put her in the hospital at the time of follow-up. No additional information was provided at that time. The patient was redirected to her hcp. A supplemental report will be filed if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3534208
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dennis100
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« Reply #12 on: March 28, 2014, 11:59:20 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient had their first programming episode in the doctor¿s office and they had a good response with mobility but they also complained of nausea. It was noted the patient had a lot of nausea, discomfort, and ¿lots and lots of dyskinesia,¿ especially freezing and ¿hypernicity. ¿ it was noted the health care professional (hcp) ¿backed it way down again¿ and then incremented it up but the side effects never went away. It was stated the patient¿s nausea and abdominal fullness and gassiness got worse and worse. It was noted the patient saw their hcp on (b)(6) 2013. It was noted they had tried several different sites. It was noted at the beginning of (b)(6) 2014 the patient did not have any dyskinesia but their movement ¿wasn¿t terrific and they still had a lot of freezing, horrendous gastroparesis, bloated stomach, intestinal bloating after eating, miserable all of the time, and they constantly tried to have a bowel movement. ¿ it was noted the hcp did not think the vagus nerve was stimulated. It was noted after the patient took their medications, they had very slurred speech ¿like they were drunk¿ and they could barely walk. It was stated all of the patient¿s symptoms had gone on since (b)(6) 2013. It was stated the patient had constipation. It was noted the patient saw their hcp about every two weeks to adjust programming but it did not work well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3626743
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« Reply #13 on: September 07, 2015, 06:40:08 AM »

Model Number 37612
Event Date 01/08/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant: product id 3387s-40, lot# va0a55t, implanted: 2014-(b)(6), product type lead. Product id 3387s-40, lot# va0b9t9, implanted: 2014-(b)(6), product type lead. Product id 3708660, serial# (b)(4), implanted: 2014-(b)(6), product type extension. Product id 3708660, serial# (b)(4), implanted: 2014-(b)(6), product type extension. Product id 37651, serial# (b)(4), product type recharger. Product id neu_ptm_prog, product type programmer, patient. (b)(4).

Event Description
The consumer reported that the implantable neurostimulator (ins) had turned off four times since implant, most recently on (b)(6)-2015. This was followed by the patient shaking each time; his indications for use were parkinson's dual and movement disorders. It was unknown if the ins was depleted after the instances, except the most recent; it was not specified if there was depletion or not. The patient had a loss of stimulation, even though the programmer showed it was on. The patient also experienced sickness, nausea and dizziness, several times since implant. It happened when the doctor adjusted the patient's settings or when the ins was off and turned back on no reason for the ins turning off, no interventions, and no patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4965089
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