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Author Topic: Deep brain stimulator - Dizziness/Fainting  (Read 22630 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
dennis100
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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
dennis100
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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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« Reply #30 on: March 29, 2014, 12:26:54 AM »

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386252
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dennis100
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« Reply #37 on: February 07, 2015, 12:09:19 PM »

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

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

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4898563
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dennis100
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« Reply #39 on: September 16, 2015, 11:57:08 PM »

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

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

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

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

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

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