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Author Topic: Deep brain stimulator - Dizziness/Fainting  (Read 20494 times)
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dennis100
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« on: November 06, 2013, 01:16:01 AM »

Model Number IPGNEURO
Device Problem No Known Device Problem
Event Date 04/29/2010
Event Type  Death  
Patient Outcome  Death
Event Description
Literature: williams a, gill s, varma t, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced parkinson's disease (pd surg trial): a randomised, open-label trial. Lancet neurol jun 2010;9(6):581-591. Summary: this article discussed the results of a one-year f/u in an ongoing, randomized, open-label trial involving 13 centers in (b)(6) of 366 patients with parkinson's disease (pd) that was not controlled by medical therapy who were randomly assigned between (b)(6) 2000 and (b)(6) 2006 to immediate surgery (deep brain stimulation) and best medical therapy or best medical therapy alone. The subthalamic nucleus was the target in 174 out of 178 surgery patients, and 176 of the 178 procedures were bilateral. Patients in both groups received medical therapy, which could have included apomorphine, other dopamine agonists, monoamine oxidase type b inhibitors, cathechol-o-methyltransferase inhibitors, amanatadine, or other drugs used for pd. The primary data used was pt self-reported quality of life on the 39-item pd questionaire. Clinical assessments of functioning using the unified parkinson's disease rating scale in both on and off states and cognitive states using the dementia rating scale-ii also were performed. Changes between baseline and one year were compared. Serious and non-serious adverse events were also recorded. Serious adverse events were defined as those events that resulted in a prolonged stay in the hospital, hospital admission, were thought to be life-threatening, or resulted in death. Reportable event: all of the following events were designated "serious adverse events" as defined above: one pt died from hemorrhage during implantation surgery. Two patients experienced surgery-related hemorrhage. One pt had a hemorrhage five months after surgery. The hemorrhage was considered "probably not" treatment related. Sixteen pts developed surgery related infections. Five patients experienced post-operative confusion that was considered dbs-specific. Two patients experienced neck pain that was considered surgery related dbs-specific. Two patients experienced seizures that were considered surgery related, dbs-specific. One pt experienced deteriorating control of pd because the battery was switched off. There was no allegation that the device malfunctioned. One pt experienced psychosis that was considered surgery related, dbs-specific. One pt became unresponsive on the operating table. The authors believed this possibly to be related to levodopa withdrawal. One pt experienced visual neglect from edema that was considered surgery related, dbs-specific. Four patients experienced urinary retention that was considered general surgery related. Two patients experienced pulmonary embolism that was considered general surgery related. One pt experienced an anxiety attack that was considered general surgery related. One pt experienced post-operative hypotension. In one pt, there was difficulty removing the catheter after surgery. One pt experienced pyrexia that was considered general surgery related. Three patients experienced falls that were considered pd related and/or drug related. Two patients experienced constipation that was considered pd related and/or drug related. One pt experienced two episodes of constipation that was considered pd related and/or drug related. Eleven patients experienced worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related. One pt experienced two episodes of worsening of pd symptoms or uncontrolled pd symptoms that were considered pd related and/or drug related.
 
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. At this time, no add'l info was available, add'l info regarding the pt, event, interventions and outcome has been requested. Two patients experienced chest pain that was not categorized as surgery related or pd related or drug related. One pt experienced angina that was not categorized as surgery related or pd related or drug related. Three patients experienced pain that was not categorized as surgery related or pd related or drug related. Three patients experienced neuropsychiatric disturbance (including hallucinations or paranoia) that were considered pd related and/or drug related. One pt attempted suicide that was considered pd related and/or drug related. The pt previously had attempted suicide prior to trial entry. Two patients had unspecified pd drug related adverse events. Two patients experienced chest infections that were not categorized as surgery related or pd related or drug related. One pt collapsed, which was not categorized as surgery related or pd related or drug related. One pt experienced deep vein thrombosis more than 8 months after surgery that was not categorized as surgery related to pd related or drug related. One patient experienced pulmonary embolism more than 8 months after surgery that was not categorized as surgery related, pd related or drug related. One pt experienced a fainting episode that was not categorized as surgery related or pd related or drug related. One pt experienced vertigo that was not categorized as surgery related or pd related or drug related. Five patients experienced urinary problems that were not categorized as surgery related or pd or drug related.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116650

« Last Edit: September 16, 2015, 11:51:26 PM by dennis100 » Logged
dennis100
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« Reply #1 on: November 06, 2013, 07:02:37 AM »

Model Number IPG
Device Problem Device-device incompatibility
Event Date 02/08/2010
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Literature: blomstedt p, jabre m, bejjani b, koskinen lo. Electromagnetic environment influences on implanted deep brain stimulators. Neuromodulation. 2006;9:262-9. Summary: this article retrospectively analyzed data concerning the effects of external electromagnetic fields on 172 patients implanted with dbs. The objective of the study was to report the authors' observations on the external electromagnetic field influences on dbs in their patient population, and how these influences affected the patients' lives and other healthcare-related conditions. Reportable event: one patient with bradycardia with third degree av block, underwent implantation with a cardiac pacemaker. The patient's implanted dbs settings were monopolar. The patient suffered several episodes of syncope. After switching dbs to bipolar mode, syncope did not recur. The syncope was probably induced by an interference with the pacemaker resulting in inadvertent pacing inhibition and bradycardia. See literature article with mfr report# 3007566237201002001.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637064
« Last Edit: September 16, 2015, 11:26:32 PM by dennis100 » Logged
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« Reply #2 on: December 20, 2013, 09:35:06 AM »

DATE FDA RECEIVED   08/20/1993
DEVICE MODEL NUMBER   3380
EVENT DESCRIPTION TYPE   FINAL
EVENT DESCRIPTION
PT REPORTEDLY EXPERIENCED A SENSATION OF LIGHT IN HER HEAD, DIZZINESS AND NAUSEA ON 2 SEPARATE OCCASIONS. THE LEAD IS STILL IMPLANTED ALTHOUGH IT IS NOT ACTIVE. CO IS UNABLE TO DETERMINE IF PRODUCT COULD HAVE CAUSED THE REPORTED INCIDENT THEREFORE THIS MDR IS BEING SUBMITTED. THERE IS NO PLAN TO EXPLANT THE PRODUCT. NO DEATH OR INJURY HAS BEEN REPORTED.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/Detail.CFM?ID=329472
« Last Edit: September 16, 2015, 11:48:17 PM by dennis100 » Logged
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« Reply #3 on: December 29, 2013, 05:38:28 AM »

Model Number 7426
Device Problem Difficult to position
Event Type  Injury  
Patient Outcome  Hospitalization
Event Description
During the implant procedure, the patient experienced ocular deviation. The hcp determined that the electrode may have been too deep and this was readjusted. After surgery, the patient's ocular difficulties resolved but patient complained of continued dizziness, and more concern with memory difficulties. Family member noted patient frequently gets lost while out of the house. Postoperative ct showed the electrode was superior and not near areas of the brain the hcp would expect to be responsible for dizziness or memory problems. The patient was referred for a more detailed neurological consultation. The hcp stated the patient had appointment in 2001 with finding of memory problems, falls, double vision in left eye, difficulty moving eyes to the left, problems with feeding self and writing with right upper extremity. The patient had deep brain stimulation amplitude decreased to 0. 0. A head ct was performed. When deep brain stimulation was activated, the patient's symptoms became worse after 5 minutes. The patient was last seen 2/2001, when the device was turned off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=384228
« Last Edit: September 16, 2015, 11:27:30 PM by dennis100 » Logged
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« Reply #4 on: January 01, 2014, 05:09:00 AM »

Model Number 7428
Device Problems Intermittent continuity; Noise
Event Date 03/06/2006
Event Type  Other  
Patient Outcome  Hospitalization,Other
Manufacturer Narrative
Final device analysis results reveal - no anomaly found - normal device function.

Event Description
Hcp reports a dystonia patient who is exeriencing a buzzing and switching on/off of the ins device. In 2005, the pt underwent a scheduled revision of the ins due to near battery depletion. In january, the patient started experiencing buzzing in both ears. The buzzing was audible externally. In march, 2006 the ins device suddenly turned off and the patient was taken to the hospital. The settings were verified and the buzzing appeared to have stopped. The buzzing had ceased so the patient was released. The patient still continued to experience sudden turning off of the device and had to continually turn it back on with the patient programmer. In 2006 the hcp replaced the ins device and returned it to the manufacturer for analysis. The patient remained in the hospital until april 2006 with no issues. After the patient returned home the buzzing and switching on/off were again reported with the new device. The electromagnetic fields around the patient's house were measured but found to be at non critical levels. The patient has had episodes of fainting due to the device unexpectedly turning off. The device was explanted and returned to the manufacturer for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=729342
« Last Edit: September 16, 2015, 11:28:16 PM by dennis100 » Logged
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« Reply #5 on: January 01, 2014, 05:09:43 AM »

Model Number 3387
Device Problem Device remains implanted
Event Date 06/28/2006
Event Type  Other  
Patient Outcome  Hospitalization
Event Description
Hcp reports va dbs patient having unusual behavior and fainting episodes. Concerned of possible stroke. Hcp reports, the patient was admitted to the er in 2006, due to episodes of fainting. While in the er, the patient reportedly had low blood pressure and dehydration. The patient was dehydrated and sent home the next day. Due to unusual behavior (unspecified), the patient was readmitted to the er for concern of possible stroke. Head ct was performed and showed no abnormalities. Chest x-ray was performed due to shortness of breath and was unremarkable. Patient was again sent home to be followed up in clinic. At the time of this report, the patient was reportedly taking the following concomitant medications: stale vo 150, sinemet cr, lexapro, lipitor, lisinopril, plavix, aspirin, toprolol, zetia, skelaxin, diclofenac sodium. The hcp reports the events were "possibly due to orthostatic hypotension which could possibly be due to disease progression". The outcome is reported as ongoing. A follow up report will be sent when additional information is received. Same as mfr report #2649622200601265.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=745071
« Last Edit: September 16, 2015, 11:28:50 PM by dennis100 » Logged
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« Reply #6 on: January 01, 2014, 05:11:06 AM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Date 11/01/2006
Event Type  Injury  
Patient Outcome  Other
Event Description
Info rec'd by the mfr from a pt indicates the hcp performed a lead adjustment on the pt 1 week ago. Subsequent to the device revision the pt experienced symptoms of dizziness, difficulty walking and speech loss. The pt also provided they have experienced symptoms similar to the flu. The rep reviewed possible adverse effects with the pt and redirected the pt to follow up with their health care provider to report symptoms and be seen for medical eval. Add'l info has been requested from the hcp regarding the reported event. A follow up mdr will be sent if add'l info becomes available. See mfr report 2649622200602269.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=797254
« Last Edit: September 16, 2015, 11:29:18 PM by dennis100 » Logged
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« Reply #7 on: January 01, 2014, 05:12:03 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Type  Malfunction  
Patient Outcome  Other
Event Description
Information received from a patient to the mfr indicates that after a study had been performed on their leg, the patient experienced symptoms of dizziness. Inspection by the patient after the study found the device turned off. It is unknown whether the patient told the study personnel prior to the procedure about the implanted neurostimulator. Additional information provided by the patient indicates the device also turns off after the patient passes through theft detectors. The medtronic representative reviewed compatibility information with the patient (electrical devices or magnets that may interfere with the product), and also redirected the patient to report symptoms to their physician. Additional information has been requested by medtronic from the healthcare professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=844031
« Last Edit: September 16, 2015, 11:30:09 PM by dennis100 » Logged
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« Reply #8 on: January 03, 2014, 07:31:36 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 03/14/2004
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
Information received indicates the patient suffered a fall related to dizziness. While in a hotel room, the patient sustained a fall with head trauma near the area over the right dbs probe (lead), and a 3-cm right forehead laceration. The patient was hospitalized for observation; the sae resolved within one day of event onset.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=835420
« Last Edit: September 16, 2015, 11:30:51 PM by dennis100 » Logged
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« Reply #9 on: January 09, 2014, 05:38:49 PM »

Model Number 7426
Device Problems Device remains implanted; Implant, reprogramming of; No telemetry
Event Date 03/01/2008
Event Type  Malfunction  
Patient Outcome  Required Intervention
Event Description
It was reported that the pt had experienced symptoms of dizziness and felt light-headed when laying on their right side; date of onset was unk. The hcp reported there was no telemetry obtained from the left-sided pulse generator at follow-up for reprogramming in 2008, and battery failure was suspected. The right-sided battery had shown a drop in measured voltage levels from 3. 72v and 2. 69v, and bilateral replacement of both pulse generators was anticipated. A delay to obtain insurance approval had caused pt anxiety and lack of sleep. The pt had experienced emotional changes from stress; symptoms of dizziness had almost resolved. The product would be returned for analysis after explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1056266
« Last Edit: September 16, 2015, 11:31:24 PM by dennis100 » Logged
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« Reply #10 on: January 09, 2014, 05:39:48 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
« Last Edit: September 16, 2015, 11:53:52 PM by dennis100 » Logged
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« Reply #11 on: January 12, 2014, 05:29:21 PM »

Model Number 7482
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 01/01/2008
Event Type  Malfunction  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that while the pt's neurostimulator on the right side was turned on, the pt's experienced dizziness and numbness on his left side. The symptoms subside when the device is turned off. Impedances were check and some of the unipolar pairs were >2000 ohms; 0 and 1 were <50 ohms. The pt was implanted for torrente's syndrome and hit his head often. An x-ray and ct scan were done 02/2008 and did not show lead movement or fracture. On a week later, the hcp reported electrodes 2 and 3 showed an impedance of 2000 ohms; electrodes 0 and 1 showed an impedance of 65 ohms. The hcp confirmed the pt had suffered a fall and hit his head. On the next day, the hcp reported that impedances were >2000 ohms on electrodes 2 and 3; 0 and 1 were <250 ohms. The pt symptoms were paresthesias and motor weakness. The hcp further reported on the following month that the pt had experienced a lack of effect, shocking, and sensory changes. Devices reprogramming was done between original month and the following month with limited effect. The hcp planned to do a revision of the extension and neurostimulator. The hcp reported the final pt outcome as "recovered without sequela".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1016901
« Last Edit: September 16, 2015, 11:32:08 PM by dennis100 » Logged
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« Reply #12 on: January 13, 2014, 08:49:06 AM »

Model Number 3387
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 03/14/2000
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
The hcp reported that while the pt's neurostimulator on the right side was turned on, the pt experienced dizziness and numbness on his left side. The symptoms subsided when the device was turned off. Impedances were checked and some of the unipolar pairs were >2000 ohms; electrodes 0 and 1 were <50 ohms. The pt was implanted for tourette's syndrome and hit his head often with his hand. An x-ray and ct scan were done 2/2008 and did not show lead movement or fracture. On a week later, the hcp reported electrodes 2 and 3 showed an impedance of 2000 ohms; electrodes 0 and 1 showed an impedance of 65 ohms. The hcp confirmed the pt had suffered a fall and hit his head. On the next day, the hcp reported that impedances were >2000 ohms on electrodes 2 and 3; electrodes 0 and 1 were <250 ohms. The pt symptoms were paresthesias and motor weakness. The hcp further reported on the following month that the pt had experienced a lack of effect, shocking, and sensory changes. Device reprogramming was done between five days prior to original month and the following month with limited effect. The hcp planned to do a revision of the extension and neurostimulator. On nine days later, the extension was replaced and still had abnormal impedances on some pairs. See mfr's report # 6000153200801420. The hcp planned to revise the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026400
« Last Edit: September 16, 2015, 11:32:41 PM by dennis100 » Logged
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« Reply #13 on: January 14, 2014, 08:27:47 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Malfunction  
Event Description
The pt had been fine since implant, until the last month or two. Since then, the pt's blood pressure had been up and down and he was passing out. He passed out four times. Three of the times, his blood pressure was very low (99/67); in 2008, when he passed out, his blood pressure was high (167/113). The pt's wife was wondering if the deep brain stimulation system could be causing the problem. She stated his doctor didn't have an answer. Add'l info has been requested, a follow-up report will be sent if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213778
« Last Edit: September 16, 2015, 11:33:07 PM by dennis100 » Logged
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« Reply #14 on: January 16, 2014, 01:34:16 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 16, 2015, 11:33:37 PM by dennis100 » Logged
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« Reply #15 on: January 16, 2014, 06:11:31 AM »

Model Number 7428
Device Problems Replace; Implant, reprogramming of; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
The pt was scanned with a security wand at an airport. His deep brain stimulator was 'zapped'. The pt immediately became dizzy, felt sick to his stomach, and fell to his knees. Two hours later, he had recovered and flew home. Several days later, the dystonia muscle spasms treated by the device gradually returned. Two months later, the deep brain stimulator was interrogated. The tests showed that the stimulator, battery, and electrodes were fine. There was no power on reset reading or out-of-range impedances. The pt's health became worse. He was unable to go for long walks, had difficulty sleeping and eating. The neck muscle spasms were periodically getting worse. The pt increased the device output with his pt programmer but became worse afterward. There were no symptoms changes if the deep brain stimulator was on or off. The hcp tested the implantable system again several months later. The diagnostic tests showed that the device was working correctly. Two months later, the pt 'could barely function'. The hcp turned the device off and the pt felt better for a couple of days. While the device off, the dystonia symptoms were not as severe as they were prior to deep brain stimulation. Head and neck x-rays taken one month later showed that no wires were broken and that the connections were intact. The pt was having difficulty walking or doing any other activities. About 4 months later (one year after the airport incident), the deep brain stimulator was replaced. The pt felt much better afterward. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248090
« Last Edit: September 16, 2015, 11:34:12 PM by dennis100 » Logged
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« Reply #16 on: January 17, 2014, 08:16:47 AM »

Model Number 7428
Device Problem Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 01/01/2009
Event Type  Malfunction  
Event Description
The patient experienced dizziness and nausea when he sat in a hybrid car. The symptoms were lessened if he sat in the back seat. 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=1343317
« Last Edit: September 16, 2015, 11:34:37 PM by dennis100 » Logged
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« Reply #17 on: January 17, 2014, 01:34:48 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 01/01/2009
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
The device had been working appropriately; the pt had no difficulties turning off the device at night. The pt reported spontaneous turn-off of the device; on one occasion it cause him to slump out of his chair, he hit the back of his head and got briefly dazed. When the pt turned the device back on, he felt an abrupt "jolt" with exaggerated head tremors and hand tremors that settled down gradually over 45 minutes instead of the usual 3 to 5 minutes. Treatment was initiated for possible epilepsy with no change in symptoms, so treatment was discontinued. At physical exam left tenderness over nape of neck, connectors from burrhole to ipg intact, intentional action tremor. Ipg reads -2+1, amp 3. 1 pw 90 rate 185, 45% usage time, multiple activations, impedance 1016, ampl 5. 6, 45% usage time. Battery voltage 3. 75. The pt was admitted to the hosp for observation; for device malfunction and sudden stimulation surges, causing confusion/presyncope and resultant concussion. Two days later, the device was replaced. It was reported he recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1328006
« Last Edit: September 16, 2015, 11:35:08 PM by dennis100 » Logged
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« Reply #18 on: January 17, 2014, 07:21:09 PM »

Model Number 7428
Device Problem Device remains implanted
Event Type  Injury  
Event Description
It was reported the pt experienced a headache and a periodic pulling feeling after a fall. The pt fell after blacking out while stepping off a porch. The pt had no other symptoms. The implanted dbs device works well. The physician checked the device and stated 'everything looks ok. " the pt was on ineffective pain medication for the headaches. The symptoms were felt at the lead location on the left side of her head. The pt remained at home in good status.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1302492
« Last Edit: September 16, 2015, 11:35:38 PM by dennis100 » Logged
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« Reply #19 on: January 17, 2014, 07:21:43 PM »

Model Number 7428
Device Problems Output, high; Improper or incorrect procedure or method
Event Date 01/01/2009
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt presented to the er with symptoms of dizziness and blurred vision. The pt had been experiencing a return of some of the parkinson's symptoms so he turned his stimulation system up. The hcp was suspicious that the increased stimulation could have caused the symptoms. It was unk at the time of this report how high the stimulation was turned up (amplitude). The device may not have had an upper limit programmed. The device settings were being investigated. The pt was admitted to the hospital for observation but was in fair condition. The symptoms subsided when the stimulation was decreased with the pt programmer. The er also performed a ct scan which was negative for signs of a stroke. The increased amplitude of the stimulation was suspected to be the catalyst for the symptoms but other medical conditions were bing ruled out. 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=1304664
« Last Edit: September 16, 2015, 11:36:10 PM by dennis100 » Logged
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« Reply #20 on: January 19, 2014, 01:00:07 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 16, 2015, 11:36:39 PM by dennis100 » Logged
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« Reply #21 on: January 19, 2014, 11:50:51 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient had a tooth pulled at the dentist, and when she got home, she passed out and stopped breathing-it was like a seizure. It was not clear what intervention was required. The patient saw her neurologist the day before the appointment, and the device was turned off and then back on in the office (timeline unclear). Further information is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1416306
« Last Edit: September 16, 2015, 11:37:15 PM by dennis100 » Logged
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« Reply #22 on: January 20, 2014, 02:47:44 PM »

Model Number 7428
Device Problem No Information
Event Date 07/01/2009
Event Type  Malfunction  
Manufacturer Narrative
(b) (4).

Event Description
The pt experienced dizziness and burning sensation when she reached for the microwave three weeks ago. It was felt that it could be scar tissue that broke up when the pt reached causing burning perhaps a lead short. There was no known accident related to the event. Add'l info has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497777
« Last Edit: September 16, 2015, 11:37:43 PM by dennis100 » Logged
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« Reply #23 on: January 21, 2014, 01:05:50 AM »

Model Number IPGNEURO
Device Problem Intermittent continuity
Event Date 01/01/2009
Event Type  Malfunction  
Manufacturer Narrative
(b) (4).

Event Description
It was reported that since the device was replaced several months ago, the patient had been experiencing increased stimulation about 50 times per day. The patient stated it felt like the stimulation was going off and then on. The patient noted he was "a little dizzy". The logs noted no activations and impedances looked good at 486 ohms and current was 82, 1-, 2-, c+. One electrode was out of range, but not being used. The patient had device reprogrammed as contact 1 had previously been negative and was changed to contact 2 negative and increased the amplitude. 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=1516803
« Last Edit: September 16, 2015, 11:38:14 PM by dennis100 » Logged
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« Reply #24 on: January 22, 2014, 08:42:48 AM »

Model Number 7424
Device Problem Device operational issue
Event Date 02/08/2010
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

Event Description
Literature: blomstedt p, jabre m, bejjani b, koskinen lo. Electromagnetic environment influences on implanted deep brain stimulators. Neuromodulation. 2006;9:262-9. Summary: this article retrospectively analyzed data concerning the effects of external electromagnetic fields on 172 pts implanted with dbs. The objective of the study was to report the authors' observations on the external electromagnetic field influences on dbs in their pt population, and how these influences affected the pts' lives and other healthcare-related conditions. Reportable event: one pt fainted while using an electrical welding machine. After the fainting episode, his ipg began to act erratically, turning itself on and off randomly, both during the day and at night. The parameter settings of the stimulator were not affected and nothing abnormal with the device was discovered when checking the stimulator with the programmer console. The stimulator was removed for examination, and showed irreversible damage to the magnet on/off switching mechanism. This ipg was replaced with another device of the same type.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1636399
« Last Edit: September 16, 2015, 11:38:48 PM by dennis100 » Logged
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« Reply #25 on: January 22, 2014, 09:14:47 AM »

Model Number 7426
Device Problem No Information
Event Date 12/11/2009
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt was found unconscious. The pt was treated for a potential seizure occurrence, but it hadn't been substantiated during the course of treatment at that time. The pt had come out of event cognitively, though he was still receiving dialysis and it was unclear how much kidney damage had occurred. It was unclear if neurostimulation played a role in the event. The pt had 2 episodes of "syncope" in the past, but there was no history of epilepsy, only 2 episodes of syncope. One of these was after giving blood, which was not uncommon and did not sound like a "seizure". The pt was a young onset parkinson's disease pt who was healthy otherwise. Prior to event, the pt did have a medicine change of azelect from 0. 5mg to 1. 0mg but it was unclear if this was relevant. Stimulation was turned off after event occurred, and pt was still healing. Ct scan showed no obvious issues. He received an mri of the brain and an mra, both normal. Add'l info has been requested, a f/u report will be submitted if add'l info becomes available. Please see mfr. Report # 3004209178-2010-00333.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580208
« Last Edit: September 16, 2015, 11:39:17 PM by dennis100 » Logged
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« Reply #26 on: January 22, 2014, 09:52:32 AM »

Model Number IPG
Device Problem Device-device incompatibility
Event Date 02/08/2010
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).

Event Description
Literature: blomstedt p, jabre m, bejjani b, koskinen lo. Electromagnetic environment influences on implanted deep brain stimulators. Neuromodulation. 2006;9:262-9. Summary: this article retrospectively analyzed data concerning the effects of external electromagnetic fields on 172 patients implanted with dbs. The objective of the study was to report the authors' observations on the external electromagnetic field influences on dbs in their patient population, and how these influences affected the patients' lives and other healthcare-related conditions. Reportable event: one patient with bradycardia with third degree av block, underwent implantation with a cardiac pacemaker. The patient's implanted dbs settings were monopolar. The patient suffered several episodes of syncope. After switching dbs to bipolar mode, syncope did not recur. The syncope was probably induced by an interference with the pacemaker resulting in inadvertent pacing inhibition and bradycardia. See literature article with mfr report# 3007566237201002001.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1637064
« Last Edit: September 16, 2015, 11:39:48 PM by dennis100 » Logged
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« Reply #27 on: January 23, 2014, 09:05:29 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
« Last Edit: September 16, 2015, 11:40:26 PM by dennis100 » Logged
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« Reply #28 on: January 23, 2014, 09:50:28 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/01/2010
Event Type  Injury  
Patient Outcome  Hospitalization,Other
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was (b) (6). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Event: a (b) (6) pt developed a mild contralateral hemiparesis after the operation. No hemorrhage or other findings of interest were seen on repeated ct scans. The hemiparesis had regressed completely at the eval after 6 months, but the pt experienced dizziness when standing up, forcing her to use a walking support when walking outside the home. The symptoms were not improved by turning the stimulation off. See literature article with mfr report #3007566237-2010-03700.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676372
« Last Edit: September 16, 2015, 11:41:03 PM by dennis100 » Logged
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« Reply #29 on: February 07, 2014, 08:45:47 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/19/2013
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Issar, n. M. , hedera, p. , phibbs, f. T. , konrad, p. E. , neimat, j. S. Treating post-traumatic tremor with deep brain stimulation: report of five cases. Parkinsonism <(>&<)> related disorders. 2013;19(12):1100-1105. Doi: 10. 1016/j. Parkreldis. 2013. 07. 022. Summary: post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma. However, literature regarding successful deep brain stimulation (dbs) treatment is scarce, resulting in ambiguity regarding the optimal lead location. Most cases support the ventral intermediate nucleus, but there is evidence to defend dbs of the zona incerta, ventral oralis anterior/ posterior, and/or a combination of these targets. We report five patients with disabling posttraumatic tremor treated with dbs of the ventral intermediate nucleus and of the globus pallidus internus. Patients were referred to the vanderbilt movement disorders division, and surgical intervention was determined by a dbs multidisciplinary committee. Standard dbs procedure was followed. Patients 1e4 sustained severe diffuse axonal injuries. Patients 1e3 underwent unilateral ventral intermediate nucleus dbs for contralateral tremor, while patient 4 underwent bilateral ventral intermediate nucleus dbs. Patients 1e3 experienced good tremor reduction, while patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands. Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity. He was treated with bilateral dbs of the globus pallidus internus and showed good tremor reduction at follow-up. Unilateral or bilateral dbs of the ventral intermediate nucleus and bilateral dbs of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor. Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor. Reported event: one (b)(6) male patient with deep brain stimulation (dbs) for post-traumatic tremor had one electrode placed in the ventral intermediate nucleus (vim) and a second electrode placed intraoperatively in the zona incerta (zi). The reporter stated that intraoperative zi stimulation reportedly caused pyramidal tract problems, including left foot pulling and pain, dizziness, apprehension, and facial contracture. It was noted that vim stimulation alone resulted in 80% reduction of the patient¿s tremor with minimal side effects, resulting in removal of the zi lead and leaving only the vim lead. The patient reportedly experienced stimulation-associated side effects including some dystonic movements of the upper extremities, gait instability, balance difficulties, paresthesias, ataxia while walking, and slurred speech. The reporter stated that the patient experienced decreased tremor control and increased impedance between six and 33 months after dbs implantation. It was noted that the patient underwent exploration and interrogation of the dbs system with replacement of the extension wire, which resulted in significantly improved tremor reduction. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3571916
« Last Edit: September 16, 2015, 11:41:57 PM by dennis100 » Logged
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