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Author Topic: Deep brain stimulator - Legs  (Read 40226 times)
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dennis100
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« Reply #60 on: January 20, 2014, 12:49:15 PM »

Model Number 7426
Device Problem Inappropriate shock
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a shocking/jolting sensation in their leg and eye on the left side of their body. Additional info 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=1470742
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dennis100
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« Reply #61 on: January 20, 2014, 02:26:26 PM »

Model Number 7428
Device Problem Inappropriate shock
Event Date 07/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced a shocking or jolting sensation randomly in her arm and leg. She additionally reported some pulling sensations that lasted for a few seconds and then goes away. The symptoms have occurred in the bathroom, at the dining table and in a restaurant. There was no correlation between the patient's positions and the symptoms. No further outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1463139
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dennis100
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« Reply #62 on: January 20, 2014, 02:29:02 PM »

Model Number 37612
Device Problem No Information
Event Type  Malfunction 
Event Description
It was reported that the pt's leg went out on them and they fell and hit their head while throwing something over a chair. This was followed by a drawer falling on them. It was also reported that the pt experienced cramping in their torso, arm, hands, and knees to toes. The cramps were alleviated with walking around. The pt had a history of blood clots. Additional info 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=1494706
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dennis100
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« Reply #63 on: January 20, 2014, 03:07:58 PM »

Model Number 3625
Device Problem Device or device component damaged by another device
Event Date 07/15/2009
Event Type  Malfunction 
Event Description
During a stage ii implant, there was difficulty removing the stage i lead from the ipg. The lead was protruding from the screw holes in the percutaneous extension. All of the screws were removed and the lead was found to be damaged. A new lead was placed, but the results were not the same as the previous lead. Pt was reported to have leg pain and no therapeutic benefit. The hcp is scheduled to place a new lead.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492214
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dennis100
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« Reply #64 on: January 21, 2014, 12:45:40 AM »

Device Problem No Known Device Problem
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: vanderhorst vg, papavassiliou e, tarsy d, shih lc. Early brain abscess: a rare complication of deep brain stimulation. Mov disord. 2009; 24(9): 1396-1397. Summary/reportable event: postoperative ct scan of the brain showed normal postsurgical changes immediately post-op. On postoperative day 3, the pt developed confusion and fever and was readmitted. There was no evidence of scalp infection at the surgical site. The pt had fluctuating inattentiveness, incoherent speech without aphasia, and left leg hyperreflexia. White blood cell count (wbc) was 15,000. Cerebrospinal fluid (csf) contained 135 wbcs, 359 rbcs, protein 51 mg/dl, glucose 98 mg/dl. Serial brain ct scans with and without contrast over the next 4 days were normal. Empirical treatment included intravenous vancomycin and meropenem. Blood and csf cultures remained negative. Repeated csf studies 4 days after readmission showed 46 wbcs, 216 rbcs, protein 71 mg/dl, and glucose 71 mg/dl. Temperature normalized but alertness continued to fluctuate. No new neurological signs developed. Brain ct scan on postoperative day 8 showed a hypodensity surrounding the right dbs electrode without ring enhancement. Brain mri on postoperative day 10 demonstrated a ring enhancing lesion with surrounding vasogenic edema in the right frontal lobe. Following mri, right frontal craniotomy showed no evidence of scalp or subgaleal infection. Reddish-gray material was found subcortically, cultures of which grew enterobacter aerogenes. The right electrode was removed. Antibiotic treatment was changed to intravenous ertapenem and was continued for 6 weeks. Mental status normalized within 2 weeks. Repeat mri at 6 weeks showed near resolution of the infection.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562460
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dennis100
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« Reply #65 on: January 22, 2014, 08:37:12 AM »

Model Number 7426
Device Problem Intermittent continuity
Event Type  Malfunction 
Event Description
See also manufacturer report 3004209178201002339. The patient experienced a loss of therapeutic effect; a return of tremors. The symptoms were worse now than before. Her legs were jumping and her body was "flailing intermittently" for three hours at a time. The device had been programmed (b) (6) 2009. It was noted that about fifteen minutes prior to the first flailing episode the patient took tylenol. There was no known related accident or incident. The patient did trip and fall in her home but it was not related to a lack of therapy. Upon checking the device all three green lights were activated on the programmer. Since the third programming session on monday (b) (6) 2009 she was having "off periods" and internal tremor. Nothing had happened after the first programming following implant. After the second reprogramming she did great for two weeks. It was further stated that the stimulation was intermittent. Further information is being requested from the hcp.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1638609
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dennis100
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« Reply #66 on: January 23, 2014, 09:16:54 AM »

Device Problem No Known Device Problem
Event Date 03/31/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: timmermann l, pauls ka, wieland k, et al. Dystonia in neurodegeneration with brain iron accumulation: outcome of bilateral pallidal stimulation. Brain. 2010; 133(pt 3): 701-712. Summary: this article presents multi-centre retrospective study of 16 centers to gather worldwide experiences with bilateral pallidal deep brain stimulation in pts with neurodegeneration with brain iron accumulation (nbia) and bilateral pallidal deep brain stimulation (gpi-dbs). Data was collected once preoperatively and at 2-6 and 9-15 months postoperatively. It was hypothesized that gpi-dbs in pts with nbia reduces dystonia, but was overall less effective than previously reported single cases and small series that were previously published. Reportable event: one pt experienced a dystonic storm leading to spontaneous open fracture of the left femoral bone. The initial worsening of symptoms resolved after several days of stimulation and the pt subsequently experienced marked benefit in severity of dystonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1661080
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« Reply #67 on: January 26, 2014, 02:49:09 AM »

Model Number 37601
Device Problem Device operates differently than expected
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was a complaint about stimulation, tingling in the left leg. Impedances 0-3 measured 1015-2449 and 8-11 measured 1396-3258. Patient was programmed 1- and 2+ on left c+ and 9- on right. Stimulation was 100% used. Company representative did know that patient needed a revision, which was done. Patient was reported doing fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1859008
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dennis100
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« Reply #68 on: January 27, 2014, 08:14:19 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that after replacement the symptom was not improved. It was noted that now the patient was in the hospital. Additional information received reported that the patient did not clarify the device. It was noted that the patient was in the hospital for further observation and they would discuss with the hospital for programming. It was noted that the patient¿s limb and tongue stiffness was aggravated. It was noted that the left body tremble was aggravated.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528574
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dennis100
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« Reply #69 on: January 27, 2014, 09:19:07 AM »

Model Number 37601
Event Date 08/09/2013
Event Type  Malfunction 

Event Description
It was reported the patient had their implantable neurostimulator (ins) replaced on the day of this report and they were shaking more than they were prior to implant. The reporter stated they were concerned that the patient¿s healthcare professional let the patient go home in that condition. The reporter further stated they were unable to use the patient programmer and did not know what needed to be done. It was noted the programmer showed 75% and ok. It was further noted the programmer showed stimulation was at 3. 09v and the patient was usually at 4. 3v and 4. 6v. Follow up information received from the healthcare professional (hcp) reported that the cause of the event was unknown and that impedances were normal. No surgical interventions had occurred and it was noted that the patient did not report any symptoms to the hcp regarding the event. It was unknown if hospitalization was required for the event. It was later reported that there was a loss of therapeutic effect. The patient was shaking and confused since the new implant was put in. It was noted that the patient was waking up in the middle of the night and asking questions about surgery that had already been discussed with the patient. The patient was scheduled for back surgery on (b)(6) 2013 and would be there for a little while. Patient was implanted but was not reprogrammed till a while later due to the patient being in and out of surgery. Patient had met with the manufacturing representative once and had some reprogramming done. The display was showing a ¿call your doctor¿ icon. There was an out of regulation (oor) condition. It was noted that when using the patient programmer to make changes was when the oor icon was showing up. Patient was unable to adjust stimulation. Additional information received reported the patient¿s battery was not turned on after battery replacement. It was noted that the manufacturing representative met with the patient and turned him back on with improvement in his tremor. Device was not related to the event. The date of the new implant was (b)(6) 2013. Patient was put back on his usual settings. Patient outcome was tremor improvement. It was noted that the date of onset was after the patient¿s rotator cuff surgery in (b)(6) 2013. Diagnostics were performed on (b)(6) 2013 and very high impedances were found at contact 1 on the left electrode. The cause of the issues was unknown though he had undergone shoulder surgery in (b)(6) 2013. Interventions taken were that the plus contact was switched from 1 to 2 on (b)(6) 2013. The patient had immediate improvement in right hand tremor and was requiring less voltage. Ins was changed in (b)(6) 2013. Patient had his l4 and l5 surgery on (b)(6) 2013 and was still recovering. Patient never had physical therapy for it and was doing arm exercises with more than the recommended 2 pounds. Since rotator cuff surgery the patient¿s right hand tremor had been worse. It was noted that the adjustment had helped some. It was noted that the patient was using a walker on (b)(6) 2013. Patient had normal facial expression, blink rate, voice volume w/mild tremor. Normal speed of gesticulations. The patient had minimal postural tremor in left hand and more prominent in the right and moderate. Trunk had some mild titubation exacerbated when standing or walking because of leg pain. Patient¿s gait with the walker was normal but had a decreased stride length and looked uncomfortable. It was noted that the night prior to this report the patient had shooting pain down his legs but no longer had that. Therapeutic impedance was high on left side. Postural tremor of right hand was minimal. Patient was able to hold a mug steady with minimal tremor after programming change. Left leg pain appeared better since the surgery on the day prior to this report. It was noted that since 2010 face/head injury and punch to abdomen and (b)(6) 2010 battery change the deep brain stimulator had never provided him with as good of relief as when initially implanted. It was noted that it was somewhat better after replacement on (b)(6) 2012. Patient felt it still was not as good as when it was initially implanted in 2006. Patient had various types of trauma that could have potentially damaged the deep brain stimulator. 0 contact was still best one after exploration of left electrode contacts. In the past the patient had some motor cramping/tightness on his left face and hand when his pulse width was increased to 90. On (b)(6) 2013 reported the patient went into the healthcare professional on (b)(6) 2013 with worsening of left leg pain. Patient had chronic back pain that had started about 10 years prior to this report. The patient had been in 5 motorcycle accidents and played hockey in high school with a number of hits and concussions. Patient also had concussions in his military years in his 20¿s. The patient¿s radiation of pain was more of a muscle spasm and cramping in the posterior and anterior thigh and had some numbness in the soles of both feet. There were no bowel or bladder problems. There was some tingling in the palms of his hands. There was no weakness in the hands or legs. The patient had some right shoulder issues felt to be the rotator cuff which had not been responsive to shots. Patient had been getting injections of l3/4 and l4/5 on the left and l5/s1 on the right and had been getting them for the past year prior to this report. Gates was mildly wide based and unsteady looking but was also painful when walking or standing. Patient was unable to relax legs. The patient had a mildly decreased vibration sense in the toes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530979
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dennis100
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« Reply #70 on: April 10, 2014, 09:31:03 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that after a replacement the patient had hallucinations, line of sight blurring, and limb stiffness during the night. The patient went for programming in (b)(6) 2013, but the effect did not improve. The patient called into consult how to deal with it. The following day it was reported that the patient still had hallucinations and limb stiffness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3662942
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dennis100
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« Reply #71 on: May 11, 2014, 08:08:20 PM »

Model Number 37602
Event Type Injury Patient Outcome Other
Event Description
It was reported there was a shocking or jolting sensation. It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report. It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant. It was noted the patient had fallen on (b)(6) 2013. It was stated they had fallen and broken their hip. It was noted the patient had not done well since the fall. It was noted the paralyzed feeling in their leg had not gone away. It was stated their arm would go paralyzed for 8 seconds and then it would stop. It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings. It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead. Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734588
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« Reply #72 on: May 11, 2014, 08:10:13 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(4) 2008, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead. (b)(4).
Event Description
It was reported that the physician¿s assistant (pa) called the reporter stating therapy impedance was high. The reporter did not have the settings or all of the impedance readings. The reporter stated that this may have been the first follow-up since implant and the patient was in for a suture check. The patient also complained of shocking down her jaw and leg that occurred every four to five minutes. The shocking would go away when the device was turned off. Palpation did not show anything and the ¿left was fine. ¿ the following day it was reported that the patient experienced shocking and a feeling of parasthesias in the left face, neck, tongue, cheek, and even in her leg that occurred every four to five minutes. It was also noted that during a clinician programmer programming session when the programmer head was pressed up against the implantable neurostimulator (ins) pocket she ¿felt a little something at the pocket. ¿ the patient was seen by the pa the day prior to the report and her impedances were checked. They looked to be within normal range, but it was noted that the clinician programmer indicated the therapy impedance was high. The reporter stopped by the clinic during the session and also got a high therapy impedance. They decreased the patient¿s voltage from 3 volts to 2. 8 volts and all of her shocking and parasthesias went away. The sensation that occurred when the programmer head touched the pocket site also went away. The patient had had good therapy since the most recent ins replacement and continued to get therapy after voltage was changed. They planned to keep an eye on the patient going forward for any changes. The patient was scheduled to be seen in (b)(6) 2014. Three days later it was reported that the patient still felt the shocking sensation, so the doctor was making arrangements to see her again the week of the report. Nine days later it was reported that the patient was to be seen again on (b)(6) 2014 for further investigation. The patient was tentatively scheduled for an extension revision. Additional information was 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=3736838
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dennis100
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« Reply #73 on: May 11, 2014, 08:11:30 PM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had a spasm on the left side implant. It was noted the patient had a lead revision due to capsular side effects. It was noted the patient status at the time of report was alive with no injury. It was further reported the patient outcome was unknown. Additional information received reported the cause of the event was a malpositioned lead. It was noted there were no abnormal impedance measurements. It was noted the patient had leg stiffness with the stimulation. It was stated after the lead was revised the patient had better tremor control and leg stiffness.
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v878980, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, 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=3733828
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« Reply #74 on: June 07, 2014, 10:17:50 AM »

Model Number 37601
Event Date 04/15/2014
Event Type Injury Patient Outcome Hospitalization,Other
Event Description
It was reported that after the surgery the patient had been in a state of a coma. It was noted that after the patient regained consciousness the activities of the right lower limb was not flexible. It was noted that there was no patient death. Additional information received reported that the no diagnostics were performed, no malfunctions were seen, and no interventions were taken or planned. It was noted that the patient lived in the hospital now.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821544
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« Reply #75 on: June 07, 2014, 10:18:25 AM »

Model Number 37602
Event Date 05/07/2014
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported the patient had complained of being shocked in the chest from the device and they had a pain that would run down the left side of their body and down their left leg. It was noted the device was explanted on the day of report. It was stated a different product was used and the issue was resolved. It was noted the patient status at the time of report was alive with no injury. It was noted the patient had a burning sensation at the device pocket at the right side implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3836594
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« Reply #76 on: June 07, 2014, 10:19:41 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported on (b)(6) 2014 that there were some out of range impedances on the right side. The measurement of unipolar 4 was 6,600 ohms, 5 was 2,400, and 6 was 2,100. The impedances were not tested at a higher setting. The patient needed a mri for possible neurological issues. The patient was seen in september or october by his healthcare provider (hcp) and at the time he was getting great therapeutic benefit. Three to five days later the patient started to have vision lapses, which lasted a few seconds, and occurred every few hours. The patient also started to experience a loss of muscle tone in his legs after visiting the hcp, describing it as ¿giving out. ¿ this occurred a few times a day. The patient was seen by other physicians and they ruled out seizures. In december the patient¿s implantable neurostimulator (ins) was turned off completely and remained off at the time of the report. The patient still had some vision differences and his legs still gave out, but he was not falling as often. The reporter noted that the patient would be having a battery replacement due to it being near end of life (eol) from normal depletion. Five days later it was reported that the patient was doing fine and he was scheduled for a battery replacement ¿in a few weeks. ¿ the following day it was reported that there were out of range impedances on the left side. However, it was noted that typical numbering suggested the impedances were for the right side. Thus, it was unclear which side had out of range impedances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3830756
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« Reply #77 on: July 05, 2014, 12:11:01 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention,Hospitalization Manufacturer Narrative
Concomitant medical products: product id 3387-28, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: lead. (b)(4).
Event Description
It was reported that 18 months prior to report, the impedance values of the patient¿s #0 and #2 electrodes suddenly decreased. It was further reported that this ¿resulted in high-power stimulation and the patient presented with symptoms of internal capsule stimulation. ¿ it was stated the patient¿s physician considered the ¿possibility of a lead problem¿ and it was decided to replace the patient¿s leads on (b)(6) 2014. It was reported that following the replacement of the lead, the patient¿s ¿impedance values had not changed at all. ¿ it was stated ¿the problem was not attributable to the lead¿ and ¿the physician did not know what might be a possible cause. ¿ additional information stated that when stimulation was performed on (b)(6) 2013 there ¿were fluctuations in the electric current value due to fluctuations in impedance. ¿ it was reported that when impedances were checked on (b)(6) 2013 ¿there were no problems with the left electrode¿ and that the right electrode¿s #0 and #2 had ¿low¿ impedances. Impedance records indicate the ¿low¿ values for contacts #0 and #2 were 346 ohms and 479 ohms respectively. It was stated the patient¿s ¿neck was still in pain¿ and that it was ¿difficult to face right. ¿ it was reported that ¿tension in the right dominant sternocleidomastoid (scm) was the most noticeable¿ and that it was also noticeable in the patient¿s right trapezius muscle. It was noted the patient had ¿botulinus administered on (b)(6) 2013 and that ¿it was difficult to control the patient¿s symptoms in their neck region, so botulinus was used concurrently. ¿ it was reported that ¿dystonia was not triggered through stimulation in the left finger like it was in the past. ¿ it was stated the patient had been previously hospitalized at a neurological hospital in (b)(6) 2012. It was further reported that impedance testing performed on (b)(6) 2014 found ¿low¿ impedances on electrodes #0 and #2 of 259 ohms and 356 ohms respectively ¿ both measured at 2. 5 volts. It was again noted these impedances were ¿too low. ¿ while performing stimulation testing it was reported the patient experienced their left hand being ¿heavy. ¿ it was stated the patient could not fully extend their fourth or fifth fingers at times during the test. Eventually it was noted the patient could extend their fourth finger ¿if done consciously. ¿ it was additionally reported that a surgery was performed on (b)(6) 2014 ¿to shift the dbs (deep brain stimulation) electrode on both sides. ¿ it was stated this was performed because ¿there was a problem with the electrode placement position itself¿ and ¿there was a concern about whether the impedance was low due to the dbs electrode. ¿ it was further stated there ¿seemed like there was a problem with the dbs electrode itself (disconnection?). ¿ it was reported that after the surgery to shift the electrodes, the impedances in the right electrodes #0 and #2 were ¿still low. ¿ the ¿low¿ therapeutic impedance values when measured at 3 volts were found to be 269 ohms and 374 ohms for electrodes #0 and #2 respectively. It was stated that ¿when the electric current was applied¿ the patient complained of ¿tingling sensations in the implantable neurostimulator (ins) region. ¿ it was further stated the patient reported the ¿ins was painful¿ and the ¿ins was tingling. ¿ it was reported it was ¿slightly difficult to extend [their] left fingers¿ and ¿slightly difficulty to bend [their] right fingers¿ during a stimulation test. It was additionally reported that during the stimulation test the patient¿s right upper limb and lower left limb were ¿slightly heavy¿ and the right bottom half of the patient¿s body ¿felt tingly and fuzzy. ¿ it was stated the patient¿s shoulder also felt ¿strained. ¿ impedance testing performed on (b)(6) 2014 indicated the right electrodes #0 and #2 had impedances of 294 ohms and 432 ohms respectively. Impedance testing also indicated the right bipolar electrode pair 1-3 had an impedance value ¿>2000¿ ohms. It was noted that electrodes #0 and #2 ¿were both five years old. ¿ additional information reported ¿electrode replacement surgery was performed, however, the resistance value was low and did not change. ¿ it was stated there was ¿possibly a problem with the electrode and there was a problem with the indwelling position of the lead as well. ¿ it was noted that on (b)(6) 2014 a lead was ¿extracted¿ and would be collected at a later date for analysis. It was additionally noted that ¿since the low resistance continues even after changing the ins and lead, the cause of the low resistance could be from the extension part. ¿ it was noted the patient was admitted to the hospital for ¿recovery¿ following their lead replacement procedure. Additional information stated ¿stinging sensations persisted¿ after the lead replacement was completed. Additional information stated the patient ¿had not had effective therapy¿ and the ¿cause was not determined¿ as of 17 days after initial report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3855294
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« Reply #78 on: July 05, 2014, 12:11:39 AM »

Model Number 7426
Event Type Injury Patient Outcome Other
Event Description
It was reported the patient was getting ¿zapped¿ in their head at the time of report. It was stated it had been going on for 2 years prior to report. It was noted a few weeks prior the patient started to have seizures more often and they thought the device might have contributed to that. It was stated the patient fell more often and they were losing strength in their legs.
Manufacturer Narrative
Product id: 3387-40, lot# j0104141v, implanted: (b)(6) 2001, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3869665
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« Reply #79 on: August 10, 2014, 06:24:10 AM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported that the patient had a loss of therapeutic effect. The reporter wanted assistance in evaluating system integrity and because the implantable neurostimulator (ins) was shutting off. The patient had developed some worsening symptoms in her right leg over the past two weeks. The patient saw the clinician in office on wednesday and was switched to group a. The patient left feeling good, but then felt stimulation was turned off and had worsening symptoms with breakthrough tremor and decline of leg usage. The leg issues resulted in slowness of movement. The patient checked the ins with her programmer and saw stimulation was off. It was not known what happened with therapy when the patient turned back on. The patient was then seen on friday and found that she had switched to group b. The patient was reprogrammed back to group a, but ¿six hours later she felt like it shorted out on her. ¿ the device usage seen on friday showed that one day group a ¿had dashes in the middle and said aaa. ¿ the patient noted that she did not s witch back and forth often and was mostly in group b. When in group a the patient was more dyskinetic and had some tremor break out. It was also noted that since replacement the patient had not had the same therapy as before. The reporter then saw the patient on the day of the report and took impedances in different positions. While looking up the patient had a low impedance of 60 ohms on electrode combination 2 and 3. The patient also had high impedances over 4,000 ohms while looking down, right, left, and a normal head position on electrode combination 0 and 3. It was also noticed that the battery voltage was 2. 96 and dropped to 2. 7 during no therapy and then back up to 2. 95 again. Two days later it was reported that the patient appeared to be experiencing a short between contacts 2 and 3. The issue was device related and it was unknown how much therapeutic effect was experienced by the patient. The doctor performed x-rays looking for signs of damage. The reporter was able to recreate the low impedance when the patient turned to the right. At the time of the report the plan was to replace the extensions on (b)(6) 2104.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 3387s-40, lot # v069269, implanted: (b)(6) 2008, product type lead; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, 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=3910262
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« Reply #80 on: September 06, 2014, 12:51:26 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: 3387, lot# unknown, product type: lead. (b)(4).
Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 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=3976613
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« Reply #81 on: September 06, 2014, 01:51:07 AM »

Model Number 37601
Event Type Injury Patient Outcome Hospitalization
Event Description
Additional information received reported that there was a 50% or greater symptom reduction. The cause of the event was not determined, but it was not device related and did not require reprogramming. The patient was hospitalized due to disorientation and confusion. The patient was in a group home setting as well. No interventions or action were taken and the patient outcome was unknown.
Manufacturer Narrative
Concomitant medical products: product id 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389s-40, lot# v333543, implanted: (b)(6) 2009, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389-40, lot# l75963, implanted: (b)(6) 2000, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 7495-25, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. (b)(4).
Event Description
An emergency room (er) doctor reported that the patient had a sudden loss of therapeutic effect as it happened within the past one or two days. The patient presented to the er on the day of the report with decreased alertness and tonic-clonic tremors in his arms and legs. The symptoms were worse on the left side than the right. The patient¿s wife felt like this was a return to baseline symptoms for him. It was requested that a manufacturer representative come check the patient¿s system as there was no patient programmer available. No patient intervention or outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3999664
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« Reply #82 on: October 13, 2014, 12:37:14 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 #83 on: October 13, 2014, 01:39:56 AM »

Model Number 37603
Event Date 08/15/2014
Event Type Malfunction
Event Description
It was reported they were unable to adjust stimulation. They questioned whether the stimulation was on or not. The device was powered off. Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off. The patient¿s stimulation was turned back on for therapeutic use. The symptoms had a sudden onset. The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer. The patient had noticed a difference in stimulation on the morning of report. The patient had freezing of their left leg and foot. They had been having problems with the therapy for the last week. They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment. The last programming adjustment helped with their prior symptoms ¿for the most part. ¿ the patient felt okay. The stimulation was noted to be back on.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4073049
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« Reply #84 on: November 07, 2014, 11:02:36 PM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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« Reply #85 on: November 08, 2014, 01:48:07 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4182435
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« Reply #86 on: November 08, 2014, 03:15:31 AM »

Model Number 37751
Event Date 09/22/2014
Event Type Other
Event Description
I had a metronic neurostimulator implanted in (b)(6) 2014 then my legs became weak, joints feel like i have arthritis, had chronic low grade temp, burning at battery and pain every where leads, battery and paddle implanted, had so much weakness in my legs that i was having trouble walking and had to have it removed at another facility in (b)(6) 2014 and still having arthritic symptoms and back pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4190278
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« Reply #87 on: November 08, 2014, 08:30:18 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

Event Description
It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted. After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well. The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side. On the same day the patient¿s healthcare professional adjusted the target position of the right ins. Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well. On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse. The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve. Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated. Refer to manufacturer report #3004209178-2014-18342.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4144132
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« Reply #88 on: January 10, 2015, 04:03:36 AM »

Model Number 7428
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported the patient was hospitalized on (b)(6) 2014 for walking difficulty. By (b)(6) 2014, the patient¿s symptoms of walking difficulty and leg weakness had not improved after taking medicine every day. The patient suspected the implantable neurostimulator (ins) was turned off accidently before they took their medicine. On (b)(6) 2014, the patient was reprogrammed and the ins was not turned off. The patient¿s healthcare professional did increase the voltage by 0. 1v and their symptoms got much better. The cause of event was not determined and the patient was doing well at the time of this report.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4331580
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« Reply #89 on: January 10, 2015, 05:36:42 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient¿s ¿effect was stable¿ and their ¿programmer could work normally¿ following the replacement of their implantable neurostimulator (ins) on 2014-(b)(6). However, in 2014-(b)(6) the patient¿s programmer reportedly ¿couldn¿t work. ¿ furthermore, ¿the patient¿s limbs were trembling when the device was turned on. ¿ the patient¿s physician reportedly ¿judged the cause as lead disconnection. ¿ the patient¿s lead was replaced as a result. Following the lead replacement, ¿the patient¿s symptom got better and the programmer could work. ¿ it was noted the ¿patient didn¿t fall down¿ at that time. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3389-40, lot# 0204990374, implanted: 2011-(b)(6), product type lead. (b)(4). Device evaluation: analysis of the lead found ¿all four conductors were broken 3. 3 cm from the proximal end of the lead. There was also breached esc (environmental stress cracking) 8. 8 and 9. 6 cm from the distal end of the lead. ¿ it was also noted that ¿all circuits were open¿ during functional testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4325534
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