Pages: [1]   Go Down
Print
Author Topic: Deep brain stimulator - Rigidity  (Read 11411 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« on: January 14, 2014, 08:14:29 PM »

Model Number 7428
Device Problems High impedance; Implant, reprogramming of
Event Date 10/01/2008
Event Type  Malfunction  
Manufacturer Narrative
 
Event Description
One month after deep brain stimulator replacement, impedances greater than 4000 ohms were noted on some bipolar pairs. The patient experienced a lack of therapeutic effect. The patient had a urinary tract infection which may have added to her rigidity. The patient was seen by a field representative. The amplitude was programmed to 2 volts. The patient was seen 2 days later by her hcp who stated she was doing better. The impedance was 1283 ohms later. The hcp did not plan to explant the device. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1231026
« Last Edit: September 19, 2015, 01:09:22 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #1 on: January 14, 2014, 08:14:58 PM »

Model Number 7428
Device Problem Replace
Event Date 09/01/2008
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Two days after the patient went to store, he started experiencing increased shakiness, rigidity, and return of symptoms. The patient was admitted to the er; a ct scan and blood work were done and no issue was found. Turning the implantable neurostimulator (ins) off made the patient feel better. The ins was replaced. Additional information has been requested from the health care professional, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216588
« Last Edit: September 19, 2015, 01:09:49 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #2 on: January 14, 2014, 11:01:24 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury  
Patient Outcome  Other
Event Description
Literature: farris sm, giroux ml. Gait changes after deep brain stimulation for parkinson's disease in a pt with cervical myelopathy. Neurorehabilitation. 2008;23(3):263-265. We present a male pt with significant gait problems due to parkinson's disease who underwent stn dbs. Gait worsened after surgery despite significant improvements in parkinsonian signs, due to underlying spasticity previously overshadowed by his parkinsonian motor symptoms. This case illustrates an emergence of dysfunction in gait in a pt with otherwise improved function and reinforces the need for an interdisciplinary approach to the care of these pts. Reportable event: one month after implant the pt had moderate to severe bradykinesia, rest tremor and rigidity, postural instability and gait worsening with falls. Eight months later after 6 months of extensive physical therapy his gait and balance significantly improved; he was able to walk without a ambulatory aid.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161219
« Last Edit: September 19, 2015, 01:10:20 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #3 on: January 16, 2014, 12:44:34 AM »

Model Number 7426
Device Problem Device remains implanted
Event Date 08/01/2008
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a loss of therapeutic effect. He also experienced increased rigidity, balance issues, and fainting spells. The patient was admitted to the hospital. The status lights on patient programmer were assessed and the reporter confirmed that the neurostimulator light and "stim on" light were lit. The reporter was redirected to the patient's health provider. Additional information has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150404
« Last Edit: September 19, 2015, 01:10:46 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #4 on: January 17, 2014, 10:03:31 PM »

Model Number 7426
Device Problem Replace
Event Date 03/01/2009
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
The implantable neurostimulator (ins) has been returned to the manufacturer for analysis. A follow-up report will be sent when the analysis is complete.

Event Description
The patient experienced muscle rigidity on the right side when the stimulation from the implantable neurostimulator (ins) was "changed high". It occurred about 5 times a day. The patient went to see her doctor. The doctor checked the ins and found nothing abnormal in the settings of ins. So the doctor admitted the patient to the hospital to see whether the rigidity would occur or not. It did occur. The doctor then turned off the ins. The rigidity did not occur, but the tremor symptoms could not be controlled. The doctor concluded that the rigidity came from having the ins amplitude "changed high". The doctor replaced the ins.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353926
« Last Edit: September 19, 2015, 01:11:21 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #5 on: January 17, 2014, 10:04:45 PM »

Model Number 7426
Device Problem Loss of power
Event Date 02/11/2009
Event Type  Injury  
Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
The pt experienced a loss of therapeutic effect. Symptoms included muscle rigidity and shaking. The pt was admitted to the hospital for pain management. The right-sided deep brain stimulator battery light and the 'on' light did not light when checked with the pt programmer. Please see mfr. Report # 3004209178200901703. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341889
« Last Edit: September 19, 2015, 01:11:50 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #6 on: January 17, 2014, 10:09:09 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: strecker k, meixensberger j, schwarz j, winkler d. Increase of frequency in deep brain stimulation relieves apraxia of eyelid opening in patient's with parkinson's disease: case report. Neurosurgery. 2008;63(6) e1204. A male diagnosed with idiopathic parkinson's disease, since the age of 48 years suffered from micrographia and general slowing of motion. Due to motor fluctuations, drug-induced hallucinations, and severe gait disturbance, the patient underwent implantation of a deep brain stimulator of the subthalamic nucleus in 2000 with a routine exchange 2003. The patient was seen at the clinic in 2004, admitted for recurred gait disturbance and freezing. He also had hypokinesia, moderate rigidity (more on left side), hypomimia, severe dysarthria including hypophonia. Device settings were adjusted with marked improvement of hypokinesia and rigidity and speech. Gait disturbance showed some response, but occasional starting hesitation still occurred. Although, the positive effect on speech was transitory, improvement of hypokinesia and rigidity persisted. Over the next year, the patient developed apraxia of eyelid opening (aeo) that gradually worsened. Attempts to reduce the amplitude caused a worsened hypokinesia and gait disturbance. However, an increase of the stimulation frequency to 180 hz resulted in a prompt and persistent relief of aeo. Paresthesia in both hands was noticed after the adjustment of frequency, but it resolved within minutes. Dysarthria was also partially ameliorated. To test whether this would persist with lower frequencies, we set the frequency to 160 hz. The patient was still able to open his eyes, but only with considerable effort. When the frequency was changed back to 180 hz, this symptom resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324326
« Last Edit: September 19, 2015, 01:12:31 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #7 on: January 19, 2014, 12:46:10 AM »

Model Number 7426
Device Problems Inappropriate shock; Implant, reprogramming of
Event Date 01/01/2009
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a lack of therapeutic effect since the time of the implant and felt the symptoms had gotten worse over the past month. The patient symptoms were; dizziness, balance issues, trouble with speech, walking, has stiffness/rigidity, double vision, freezing constantly, weakness, and fatigue. The patient did note that he had been dizzy for the past two years. The patient stated the tremors in the right arm were worse now than before implant. The patient reported a shocking or jolting sensation every time he turned on his "lower: ipg. This resulted in a headache and "racing of heart". The device was turned off and the symptoms were gone about 2 hours later, but the patient's tremors in his right hand returned. Multiple attempts at reprogramming had been unsuccessful and the patient was requesting the leads to be explanted. Please see mfr. Report# 3004209178200904365. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1407420
« Last Edit: September 19, 2015, 01:13:08 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #8 on: January 19, 2014, 12:47:24 AM »

Model Number 7426
Device Problems High impedance; Implant, reprogramming of
Event Type  Malfunction  
Manufacturer Narrative
(b) (4).

Event Description
Two days after an extension revision (see mfrs report #s 3004209178-2009-04335 and 3004209178-2009-04336), the pt had neurological deficit symptoms which included being very rigid and immobile on the left side and the pt had speech changes. The pt had no stimulation and new pain in his left neck and chest. Impedance measurements were checked and some of the bipolar pairs were reading >4000 ohms (c/4, 4/6, 4/7). The default test values were increased to 3v and impedances measurements were as follows: 4/7>4000 ohms; c/4-2815 ohms <15 ua; 4/6-2815 ohms <15ua. The pt was programmed 4+, 5-, 6-. Even with reprogramming, the pt could only open and close his hand where as before he could walk. They were going to take an x-ray to see if they could see anything wrong with the lead. A revision was being considered. The pt's outcome was reported as "no injury". See mfr's report # 3004209178-2009-04341.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465438
« Last Edit: September 19, 2015, 01:13:43 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #9 on: January 20, 2014, 12:55:46 PM »

Model Number 7428
Device Problems Loss of power; Implant, reprogramming of
Event Type  Malfunction  
Event Description
It was reported that the pt experienced a loss of therapeutic effect and their jaw almost locked up and experienced speech and swallowing difficulties. Some of the pt's dystonia symptoms, specifically rigidity in their left hand returned. Add'l info rec'd reported that the pt's neurostimulator turned off and when power was restored, it was on an incorrect program. Reprogramming indicated that voltages had increased. Good results were observed with reprogramming. No injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478820
« Last Edit: September 19, 2015, 01:14:11 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #10 on: January 20, 2014, 01:29:10 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2009
Event Type  Malfunction  
Event Description
The pt experienced a return of symptoms while at the dentist. He was "frozen and very rigid", almost immobile. The pt had the magnet and was possibly going to use it to determine if the ins was off. The pt's wife intended to take him to the er at the hospital where the managing neurologist was located. The outcome is unk. Further info is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485134
« Last Edit: September 19, 2015, 01:14:37 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #11 on: January 21, 2014, 03:27:42 AM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009;87(5):297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved dyskinesia, but persistent rigidity, bradykinesia, and gain impairment following initial lead placement. The lead was determined to not be optimally placed. Following unilateral lead revision the pt experienced gait improvement and no adverse effects. See literature article with mfr report #3007566237-2009-08911.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562494
« Last Edit: September 19, 2015, 01:15:07 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #12 on: January 22, 2014, 09:17:30 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/15/2009
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that during a reprogramming session, the hcp changed the patient's voltage from 1. 0 volt to 1. 5 volts. It was stated that the programmer jumped up to 9. 5 volts which caused the patient to experience muscle rigidity. The voltage was turned off and reprogrammed; the patient is doing fine but is 'a little sore'. Additional troubleshooting was being considered. A follow-up report will be sent if additional information becomes available. The device related to this event was not identified. Refer to manufacturer report number: 3004209178-2010-00251.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1582138
« Last Edit: September 19, 2015, 01:15:37 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #13 on: January 23, 2014, 08:02:15 AM »

Model Number 7428
Device Problems Break; Material twisted
Event Date 02/28/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

Event Description
Literature: gelabert-gonzalez m, relova-quinteiro jl, castro-garcia a. "twiddler syndrome" in two patients with deep brain stimulation. Acta neurochir (wien). Mar; 152(3): 489-491. Summary: this article reviews the clinical cases of two patients with parkinson's disease who had subthalmic bilateral electrodes implanted and presented with twiddler syndrome 2 and 3 years after surgery. Event: the patient is a (b) (6) woman with a 12 year history of parkinsons disease, treated with levodopa and amantadine. The patient was admitted in (b) (6) 2005. Quadripolar dbs electrodes were implanted in each stn and a pulse generator was implanted in the abdominal wall 2 days later and sutured to the fascial plane. Following good clinical recovery, the 1 year follow up period showed an important reduction of symptoms. Two years later, the patient presented with a disabling tremor and increased rigidity on the right side of the body. Radiographs of the stimulation system showed the left electrode was fractured at the neck, and the extensions wires were intertwined from the neck to the abdominal bag. The patient reported having twisted the generator box because "it didn't feel right. " surgery was performed to replace the left electrode. Postoperative outcome was uneventful and the patient was discharged 6 days later. It was also noted the patient had no psychiatric disorder, however, they admitted they had often manipulated the generator in the abdominal sack without perceiving any discomfort. See literature article attached to mfr report # 3007566237201002832.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656253
« Last Edit: September 19, 2015, 01:16:19 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #14 on: January 25, 2014, 03:03:41 PM »

Model Number 7426
Device Problems Electro-magnetic interference (EMI); Device operational issue
Event Date 06/01/2010
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a loss of therapeutic effect had occurred. It was reported that the pt's symptoms had reverted back to since before her implant, in addition to having experienced symptoms worse than ever before. Symptoms noted were stiffness/rigidity, and that the pt could barely walk. Pt believed the device was inadvertently turned off by "the fridge". It was noted that the pt "currently only uses the magnet". The pt visited her hcp for device reprogramming, and was told "that 1 device was off 55% of the time and the other device was off 60% of the time". Reference mfr report # 3004209178201005612.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766826
« Last Edit: September 19, 2015, 01:16:53 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #15 on: January 26, 2014, 01:37:43 AM »

Model Number 7428
Device Problem Connection issue
Event Date 08/01/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Literature: alcindor d, oh my, baser s, angle c. Cheng bc, whiting d. Stimulation of the globus pallidu internus in a patient with dyt1-positive primary generalized dystonia: a 10-year follow-up. Neurosurg focus. Aug 2010; 29(2):e16. Summary: in this case report, the authors describe a (b)(6) old man with dyt1-positive dystonia who underwent bilateral gpi dbs and report the 10-year safety and efficacy data. The patient had 10 left ipg changes on the more symptomatic side due to higher voltage needs and 5 ipg changes on the right over 10 years. Within 3 months of stage 1 surgery, the patient experienced a dramatic improvement; they were able to return to school and function independently. Minor symptoms experienced included mild dysarthria and a subtle rigidity while walking, none of which impedes daily activities. Reportable event: there were no significant complications, neurological deficits, infection/erosion, or system malfunctions. However, 4 years after initial ipg placement, the pt had increased rigidity and more cramping on the right side with the development of diaphoresis. In the left subclavicular ipg there were extremely high impedances, and chest radiography revealed disconnection of that generator. After revision surgery, these worsening symptoms resolved and the patient has had no further episodes of symptom recurrence.

Manufacturer Narrative
After 3 ipg changes in 13 months on the left side, a kinetra (7428) ipg was inserted. It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. At this time, no add'l info was available, add'l info has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885197
« Last Edit: September 19, 2015, 01:17:37 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #16 on: October 12, 2014, 04:15:39 AM »

Model Number 7428
Event Date 08/23/2014
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the parkinson¿s disease patient¿s ¿whole body became rigid¿ the day prior to report. The patient had visited their physician in (b)(6) 2014 and was told they had 18% of the battery remaining and that ¿it could last about six months. ¿ however, when the patient used their programmer to check their battery the day prior to report, they ¿found the power indicator didn¿t light. ¿ the patient was looking to have their implantable neurostimulator (ins) replaced as soon as possible at the time of report. Additional information was requested, but was unavailable at the time of report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4101402
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #17 on: October 12, 2014, 11:26:44 PM »

Model Number 3389
Event Type Injury
Event Description
It was reported that the patient had a lead that was connected to a vagal nerve stimulation device that was a non-medtronic product. The lead had been severed and had burnt the patient¿s left vocal cord on (b)(6) 2007. This had caused the patient to have speech, breathing and swallowing problems. The non-medtronic implantable neurostimulator (ins)was replaced as they thought that was the problem however, when the ins was turned on the patient had experienced extreme discomfort and had gone stiff. The stimulator was turned off at that point and the patient was heavily medicated. Valium was one medication that was used to control the seizures. The lead had several visible fractures and it was noted that the reason for the vocal cord damage had been the fractured lead. From (b)(6) 2014 that patient had been in speech therapy due to the lead issue. It was noted that only 12-24 months prior to the date of this report had the patient¿s swallowing, breathing and speech started to improve. Later it was decided to replace the lead. The replacement had taken 9 hours to get the lead out due to scar tissue. Following the lead replacement there was tissue under the incision that had died and the patient had a ¿huge¿ scar. The incision had not closed for 4-6 weeks following the replacement of the lead. Issues had been resolved with healthcare professional intervention.

Manufacturer Narrative
(b)(4). The device was used for an off label indication. The indication the device was used for was vagal nerve stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4084629
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #18 on: October 13, 2014, 12:38:30 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient experienced stable effects after the implant of their unilateral deep brain stimulation (dbs) system. However, the patient reported to the hospital at the time of report because their ¿symptoms weren¿t controlled well¿ for the month prior to report and the ¿dbs was almost not effective in the two days¿ leading up to report. The patient¿s right side was reportedly ¿shaking and rigid¿ with ¿no¿ control of their symptoms at the time of report. When initially attempting to check the patient¿s implantable neurostimulator (ins) it was noted the physician¿s programmer ¿couldn¿t connect¿ to the ins. Review of the patient¿s programming history found the patient¿s therapy parameters were set to a medium level. The patient¿s physician reportedly ¿suspected it was ins abnormal battery depletion¿ ¿considering the ins was only used for almost 14 months in normal usage. ¿ troubleshooting of the ins was performed and confirmed the patient¿s ins had not been reprogrammed in the year prior to report. Impedance testing found ¿normal¿ impedances. It was noted that as a result, ¿short circuit couldn¿t happen. ¿ it was also noted that ¿the extreme conditions that four electric shocks appeared negative and voltage was above 3. 6 volts never happened. ¿ the exact meaning of this statement was unclear at the time of report however. Further information has been requested regarding this information. It was noted that replacement of the ins was requested as a result of the event. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4081801
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #19 on: October 13, 2014, 03:37:45 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient¿s body had convulsions and rigidity problems following an implantable neurostimulator (ins) replacement. The cause of the event was not determined and it was unknown if the cause was device related. No troubleshooting or interventions were taken and the patient asked to be reprogrammed. The patient still had convulsions and rigidity problems on the day following the initial report. It was unknown if the patient had a 50% or greater reduction in symptoms or if they were receiving effective therapy. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051076
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #20 on: November 08, 2014, 01:45:30 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that the patient experienced infection due to skin breakdown at the lead site in (b)(6) 2013, three years after implant. There were no other signs or symptoms of infection. The right lead was cut and explanted. The hcp ¿got the lead stopped working¿ and ¿wrapped it in the plastic tube. ¿ the infection resolved. On (b)(6), the patient¿s limbs became rigid and the patient suspected the left lead had stopped working. It was found that the implantable neurostimulator (ins) was off. The ins was turned on and reprogramming was performed. The patient was ¿good¿ after reprogramming.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4182435
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #21 on: April 19, 2015, 02:38:45 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, 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; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
It was reported that there was a left lead fracture adjacent to the stimloc. The action required as a result of the event was a replacement. Diagnostic testing and troubleshooting included impedance testing and x-rays. The issue was not resolved and the cause was not determined. Patient symptoms associated with the event were increasing dysphagia and rigidity in the left upper extremity. The location of the symptom was the lead location. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565375
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #22 on: April 19, 2015, 02:39:37 AM »

Model Number 37601
Event Date 01/24/2014
Event Type Injury
Manufacturer Narrative
Concomitant: product id neu_unknown_lead, product type lead. (b)(4).

Event Description
It was reported that the patient experienced shaking in the hands, rigidity in the legs, and a lisp after an implantable neurostimulator (ins) replacement on 2014-(b)(6). In (b)(6) 2014, the patient took mri films to a new physician who indicated the target location of the lead was ¿not accurate¿ and a second surgery was recommended. The patient¿s implanting physician believed there wasn¿t a problem with the target position. The patient wants to have a second surgery but no date for the surgery had been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637974
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #23 on: June 08, 2015, 06:09:43 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #24 on: September 07, 2015, 07:10:38 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/12/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, explanted: (b)(6) 2015, product type: lead. Product id: 3389-40, lot# 0209659132, implanted: (b)(6) 2015, explanted: (b)(6)2015, product type: lead. (b)(4). (b)(6).

Event Description
It was reported the patient experienced a return of rigidity symptoms after falling down. Impedance testing was performed and found ¿high impedances on his right brain. ¿ the patient¿s physician decided to replace their lead as a result of the event. Upon connecting a replacement lead with the patient¿s original extension, the physician experienced a ¿problem when he tightened the screw; he found that two electrodes were broken. ¿ the physician then stopped and removed the replacement lead. The patient¿s physician ¿planned to revise the case again¿ the month after initial report. There was ¿no¿ patient injury or death from the event. The patient was being treated with medication at the time of report and was awaiting recovery to undergo an additional revision procedure. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964692
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #25 on: September 19, 2015, 03:00:04 AM »

Model Number 37601
Event Date 03/31/2015
Event Type Malfunction
Event Description
A consumer reported that a few days after reprogramming, their dyskinesia came back. This had been occurring since implant of their initial device in (b)(6) 2009 and with each implantable neurostimulator (ins) since then. Since the initial implant in 2009, t he patient had been reprogrammed every 4-6 months. The current return of dyskinesia was worse than after the implant in 2009. The dyskinesias were better than they were in 2009, but this was still an intermittently reoccurring issue following reprogramming. Every since (b)(6) 2009, the patient¿s symptoms seem to get worse. The patient contacted the manufacturer to see if the labeling had anything about staying out of the sun. Since 2013, the patient has had issues with movement that are gradually getting worse to the point where they could barely move. The patient has to sit often and they cannot turn sides in their bed because their muscles are so stiff. The patient stated they were a ¿problem child¿ with medication since day one and that was why their neurologist suggested deep brain stimulation (dbs). The patient was bad with medication and they had every side effect. Every parkinson¿s disease medication and muscle relaxer was tried and the patient every side effect listed so they decided to try dbs. The patient¿s indication for use is parkinson¿s dual and movement disorders. The patient had an appointment scheduled with their health care provider (hcp) on (b)(6) 2015. 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 products: product id 3389s-40, lot # v182607, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3389s-40, lot # v324755, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032859
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #26 on: September 19, 2015, 03:01:04 AM »

Model Number 7428
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The consumer via a manufacturer representative reported that the patient was implanted on (b)(6) 2013 due to parkinson's disease. On (b)(6) 2015, the patient's limbs felt rigid and it was difficult for them to walk. The patient suspected that the implantable neurostimulator (ins) was shut down. The patient requested a reprogramming on (b)(6) 2015. No troubleshooting was done and the event cause was not determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5043176
Logged
Pages: [1]   Go Up
Print
Jump to: