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Author Topic: Deep brain stimulator - Electrodes  (Read 69086 times)
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dennis100
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« Reply #30 on: November 06, 2013, 06:59:21 AM »

Device Problem No Known Device Problem
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg, 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two pts underwent electrode replacement due to infection. Reference mfr report#300756623720101233.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617817


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« Reply #31 on: November 06, 2013, 06:59:41 AM »

Device Problem Migration of device or device component
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 patients. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of patients undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two patients underwent electrode replacement due to lead repositioning. Reference mfr report # 3007566237201001327.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617930

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« Reply #32 on: November 06, 2013, 07:00:04 AM »

Device Problem Fracture
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article present a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: three pts underwent electrode replacement due to rupture. Reference mfr report #3007566237201001308.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617912

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« Reply #33 on: November 06, 2013, 07:00:27 AM »

Device Problem Migration of device or device component
Event Date 01/14/2010
Event Type  Malfunction  
Event Description

Literature: lee j-y, jeon bs, paek sh, lim yh, kim m-r, kim c. Reprogramming guided by the fused images of mri and ct in subthalamic nucleus stimulation in parkinson's disease. Clin neurol neurosurg. 2010; 112(1): 47-53. Summary: this article presents a study of 65 pts with parkinson's disease who underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between march 2005 and september 2006 and had been managed for at least 6 months within conventional programming based on physiological responses. The aim of the study was to evaluate the usefulness of a visual info about the location of the contacts in dbs programming, and compare the outcome of stn before and after reprogramming guided by the fused image of mri and ct. Reportable event: some pts appeared to have a significant shift in the location of the electrodes between the immediate and 6-month post-operative ct. The shift moved in the ventral direction. The shift was felt to be partly due to csf leakage during the operation. No pt treatment or outcome was reported. Reference mfr report #3007566237201001755. See literature article attached to mfr report# 3007566237201001696.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1628499

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« Reply #34 on: November 06, 2013, 07:00:50 AM »

Model Number IPGNEURO
Device Problem Fracture
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: pereira eac, wang s, paterson dj, stein jf, aziz tz, green al. Sustained reduction of hypertension by deep brain stimulation. J clin neurosci. 2010;17(1):127-127. Summary: the article describes sustained, significant, reduction of hypertension in a (b) (6) male implanted with dbs for facial pain refractory to both pharmacological analgesia and motor cortex stimulation. Reportable event: it was reported the patient underwent surgery at 8 months post implant after an electrode fracture due to mild accidental head trauma. The patient underwent revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656947

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« Reply #35 on: November 06, 2013, 10:55:03 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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« Reply #36 on: November 06, 2013, 10:56:29 AM »

Model Number UNKNOWN
Device Problem Migration of device or device component
Event Date 11/30/2009
Event Type  Malfunction  
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced electrode migration to the subcortical region after a minor fall. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566592

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« Reply #37 on: November 06, 2013, 10:56:47 AM »

Model Number UNKNOWN
Device Problems Fracture; Migration of device or device component
Event Date 11/30/2009
Event Type  Malfunction  
Manufacturer Narrative

(b) (4).
 
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced electrode fracture at the distal end, close to the connector site. It was noted that the connector was not anchored properly and was migrating from the retroauricular region down to the neck level. The pulling and dragging force fractured the electrode. No pt symptoms, treatment, or outcome were reported. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566589

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« Reply #38 on: November 06, 2013, 10:57:06 AM »

Device Problem Malposition of device
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the patients implanted with deep brain stimulation (dbs) between 1997 to 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: two patients experienced electrode malposition. Both patients suffered intolerable stimulation side effects and underwent revision. No patient outcome was reported. See literature article with mfr report #3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566212
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« Reply #39 on: November 06, 2013, 10:57:28 AM »

Device Problem No Known Device Problem
Event Date 11/30/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an adult of all the patient's implanted with deep brain stimulation (dbs) between 1997 to 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one patient experienced a stimulator pocket abscess requiring removal of the whole system. No patient outcome was reported. See literature with mfr report # 3007566237-2009-09382.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566219
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« Reply #40 on: November 06, 2013, 10:57:47 AM »

Model Number UNKNOWN
Device Problems Fracture; Electrical shorting
Event Date 11/30/2009
Event Type  Malfunction  
Event Description

Literature: chan dtm, zhu xl, yeung jhm, et. Al. Complications of deep brain stimulation: a collective review. Asian j surg. 2009; 32(4): 258-63. Summary: this article presents an audit of all the pt's implanted with deep brain stimulation (dbs) between 1997 to the end of 2008 at one facility to assess complications arising from the 100 dbs electrode insertions and prevention of complications. Reportable event: one pt experienced a sudden loss of stimulation two months after an initial good response. Testing revealed high current drainage leading to the battery running out. Exploration revealed short circuiting due to an electrode fracture at the miniplate anchorage site. No pt treatment or outcome was reported. See literature article with mfr report #3007566237-2009-09382.
 
Manufacturer Narrative

(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566588

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« Reply #41 on: November 09, 2013, 05:23:14 AM »

Device Problem Replace
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative

 
Event Description

Journal ref: anheim m, batir a, fraix v, et al. Improvement in parkinson disease by subthalamic nucleus stimulation based on electrode placement: effects of reimplantation. Arch neurol. 2008;65(5):612-616. The objective is to evaluate whether reimplantation of electrodes in the stn can produce improvement in pts with poor results from surgery and with suspected electrode misplacement based on imaging findings. Reportable event: the only adverse effect of reimplantation was transient postoperative infection necessitating removal of the stimulator and extension lead, followed by reimplantation 2 months later with no sequelae. See mfg report 2182207200803751.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069471
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« Reply #42 on: November 09, 2013, 05:23:40 AM »

Device Problem Mislocation
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

Journal ref: anheim m, batir a, fraix v, et al. Improvement in parkinson disease by subthalalmic nucleus stimulation based on electrode placement: effects of reimplantation. Arch neurol. 2008; 65(5):612-616. The objective is to evaluate whether reimplantation of electrodes in the stn can produce improvement in pts with poor results from surgery and with suspected electrode misplacement based on imaging findings. Reportable event: a 1-year postoperative study was undertaken in 7 consecutive pts with parkinson disease who, despite bilateral stn stimulation, experienced persistent motor disability and who were operated on for reimplantation a median of 16. 9 months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069470
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« Reply #43 on: November 09, 2013, 12:30:20 PM »

Model Number IPGNEURO
Device Problems Disconnection; High impedance
Event Date 09/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported the patient's left brain electrode was not providing any real benefit and very little in the way of stimulation induced adverse effects (no dysarthria and less paresthesia than would be expected) even with monopolar at three contacts up to around 7 volts with high pulse widths (210). Her right brain electrode was providing almost complete tremor control at 1. 7 volts. Impedances were high in 0 monopolar and 0+2, 0+3 but everything else appeared fine during operating test stimulation. Current impedace readings were >4000 ohms x-rays revealed that the left lead had disconnected from the extension. The patient was scheduled for a revision in 2009. 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=1516345
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« Reply #44 on: November 09, 2013, 12:30:45 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 02/16/2009
Event Type  Malfunction 
Manufacturer Narrative

(b) (4). See manufacturer report number: 2182207200907584.
 
Event Description

Literature: o'sullivan d, pell m. Long-term follow-up of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull. 2009; 78(2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminegic aspects of the disease. Event: it was reported that the patient developed tolerance and response to stimulation failed over the follow-up period of 5 years. It was considered that the electrode had migrated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516801
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« Reply #45 on: November 09, 2013, 12:31:11 PM »

Model Number IPGNEURO
Device Problem Intermittent continuity
Event Date 01/01/2009
Event Type  Malfunction 
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

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« Reply #46 on: November 10, 2013, 03:38:45 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease, experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1): 26-35. Summary: this study evaluated 42 patients from 2005 - 2006, to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes, which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre- and post- operative mri taken at 6 months after stn dbs. Patient had not experienced any improvement of symptoms with dysarthia and gait difficulty. Also, his mri 5 months after surgery demonstrated that the dbs electrodes were positioned off the stns. The right sided symptoms of the patient were dramatically improved after the revision surgery. See manufacturer report number: 2182207200902211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353062
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« Reply #47 on: November 10, 2013, 03:39:17 AM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 10/10/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: mizukawa k, kondoh t, kohmura e. Intrathecal baclofen therapy in patients with ventriculoperitoneal shunt: a report of 3 cases. Jpn j neurosurg. 2008:17(10):794-798. Summary: review of 3 patients who have a ventriculoperitoneal shunt received intrathecal baclofen. It was reported that a head wound infection overtook a portion of the electrode and stimulation equipment. A ct scan performed shows a residual electrode for deep brain stimulation.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353060

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« Reply #48 on: November 10, 2013, 03:45:58 AM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 08/04/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: martin aj, larson ps, ostrem jl, starr pa. Interventional magnetic resonance guidance of deep brain stimulator implantation of parkinson disease. Top magn reson imaging. 2009;19(4):213-221. Summary: review the use of interventional magnetic resonance image guidance for the implantation of deep brain stimulator electrodes. The patient developed an infection associated with the extension wire connecting the ipg to the dbs electrode. This required complete removal of the electrodes. This patient was subsequently re-implanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353057
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« Reply #49 on: November 10, 2013, 03:46:23 AM »

Model Number IPGNEURO
Device Problem Device remains implanted
Event Date 03/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease; five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety or bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from 1998 to 2002. It was reported that one pt required repositioning of one electrode because of a lack of efficacy or capsular side effects. This was performed within the first 6 months after the initial surgery. See manufacturer report number: 2182207200903228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1378217
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« Reply #50 on: November 10, 2013, 05:17:55 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experiencing in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. Summary: this study evaluated a total patients from 2005 - early 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. Patient underwent re-operation to reposition the electrodes which were too medially located near or in the red nucleus. It was confirmed by the fused image of pre-and post-operative mri taken at 6 months after stn dbs. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353073

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« Reply #51 on: November 10, 2013, 05:18:31 AM »

Model Number IPGNEURO
Device Problem Internal fixation, revision of
Event Date 03/01/2005
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description

Literature: lee jy, han jh, kim hj jeon bs, kim dg, paek sh. Stn dbs of advanced parkinson's disease experienced in a specialized monitoring unit with a prospective protocol. J korean neurosurg soc. 2008:44(1):26-35. E. Summary: this study evaluated a total patients from 2005 - early 2006 to assess the short term outcome of stn stimulation for patients with advanced pd evaluated in a 24h monitoring unit for movement disorder. Patient suffered adverse effects after dbs surgery. 3d ct scan of patient examined immediately after stn dbs demonstrated that an electrode targeted on the left stn was indwelled in the third ventricle. The patient underwent re-operation two days after the initial surgery to reposition the left electrode. See manufacturer report number: 2182207-2009-02211.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353074


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« Reply #52 on: December 04, 2013, 06:06:13 AM »

Type of device:
 
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR   
Device brand name:
 
Activa   
Device manufacturer's name:
 
Medtronic Inc., Cardiac Rhythm Disease Management   
Date of this report:
(mm/dd/yyyy)
 
09/19/2013   
Describe the event
or problem:
 
Surgeon implanted a depth electrode successfully; upon completion, attempted to remove electrode through sheath. Electrode became stuck and upon further inspection was found to have a defect on one of the metal contact points. Electrode was explanted and taken off the field, and new electrode was implanted without incident. Patient experienced an extended OR time but no long term harm.   
The device(s) may have
caused or contributed to:
 
Potential for patient harm   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=110073
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« Reply #53 on: December 06, 2013, 12:57:35 PM »

Model Number 7426
Event Date 11/04/2008
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that a patient was told that ¿the electrode may be in the wrong place¿ since she had surgery in 2008 or 2009. It was stated that one doctor thought she had a stroke. It was noted that the area being stimulated ¿might be the wrong area,¿ thus the patient was going to have an mri to determine if that was the case. The patient reportedly never had a tremor before the surgery and ¿since she got the device put in her whole right side was affected but it was inconsistent. ¿ a supplemental report will be sent if any additional information is received.

 
Manufacturer Narrative
Concomitant products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2008, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v236672, implanted: (b)(4) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462533
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« Reply #54 on: December 06, 2013, 12:58:27 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 7426, serial# (b)(4), implanted: 2008 (b)(6); product type implantable neurostimulator product id 3387s-40 lot# v135050, implanted: 2008 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2008 (b)(6); product type extension product id 7482a51, serial# unknown, implanted: 2013 (b)(6); product type extension product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v384611, implanted: 2010 (b)(6); product type lead. (b)(4).

 
Event Description
All the impedances were out of range due to reference electrode 3 so the extension was replaced today. It was noted that electrode 3 was used in the patient¿s programming. During surgery, the lead was tested in the twist lock. All the impedances read normal except all combinations with 3. Combinations with 3 were in the 3000¿s ohm range. The surgeon stated that electrode 3 looked a little bent at the extension end. Although 3,000¿s was ¿in range¿, it was still high. The surgeon went ahead with replacing the right extension. It was recommended to the patient to see a neurologist to try and program around electrode 3. On (b)(6) 2013, the company representative clarified that the right lead was the one that was tested. When the new extension was attached and impedances were checked, impedances remained high with electrode 3. The surgeon was going to see if the neurologist could program around it.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3481566
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« Reply #55 on: December 06, 2013, 01:01:07 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id 3389, lot # unknown, product type lead; product id 3389, lot # unknown, product type lead. (b)(4).

 
Event Description
Amtage, f. , lambeck, j. , rutsch, s. , prokop, t. , pinsker, m. , rijntjes, m. Behind the screen: pseudobulbar symptoms after deep brain stimulation. In: nikkhah g, pinsker m, eds. Stereotactic and functional neurosurgery. Vol 117: springer vienna; 2013:43-46. Summary: thalamotomy was formerly used to treat different tremor syndromes. Nowadays deep brain stimulation has become an established technique to treat different movement disorders. The combination of these two stereotactic interventions is rare. We present a patient which a right-sided tremor syndrome with and underlying pathology of combined essential tremor and parkinsonian tremor was successfully treated initially with bilateral deep brain stimulation in the subthalamic nucleus resulted in hemidystonia pathological laughing and crying, dysarthria and dysphagia, all due to dislocation of the stimulation electrode contacting the internal capsule. After discontinuation of the high-frequency stimulation these side-effects disappeared, but were then reactivated by an lcd television in stand-by mode. In this report we discuss the pathophysiology of pseudobulbar symptoms and pathological laughing and crying in context of thalamotomy and dislocated dbs electrodes. Furthermore, we report on the occurrence that magnetic fields in the household have an impact on deep brain stimulation, even if they are in stand-by mode. Reported event: one (b)(6) female patient with a history of right-sided tremor syndrome which was treated by a left-sided thalamotomy had a deep brain stimulation (dbs) implantable neurostimulator (ins) implanted in the subthalamic nucleus (stn) for her emerging parkinson¿s disease (pd). Postoperatively, the patient complained of slight dysarthria and dystonia in the right leg when using stimulation. Several years later, the patient reportedly displayed right-sided hemidystonia and aggravation of the dysarthria, in combination with pseudobulbar signs such as dysphagia and pathological laughing and crying (plc) when the amplitude was increased. Seven years after implant, the patient admitted herself to the hospital and had a cranial ct scan taken. The ct scan revealed a dislocation of the left-sided electrode, leading to a stimulation of the medial parts of the internal capsule with the two uppermost contacts. The reporter stated that the right-sided electrode was placed in a pronounced dorsolateral position, stimulating the internal capsule at low amplitude at the second proximal contact. The reporter stated that testing of the remaining contacts for therapeutic effect reportedly showed no benefit to the pd symptoms. The ins was then switched off and the dysarthria, dysphagia, plc and right-sided hemidystonia disappeared completely; the patient was then discharged from the hospital. The patient denied a revision of the electrodes, as she was experiencing well-being under medication. The reporter stated that the patient¿s pseudobulbar symptoms were due to dislocation of both dbs stimulation leads into the internal capsule and the hemidystonic syndrome was provoked by the high-frequency stimulation of the cortico-spinal tract within the left internal capsule. The reporter suggested that there was a concomitant vulnerability of the circuit due to the left-sided thalamotomy. The reporter stated that the left-sided thalamotomy was not able to provoke plc by itself, only additional high-frequency stimulation of the internal capsule resulted in plc and other pseudobulbar symptoms. It was noted that the right-sided stimulation of the internal capsule did not produce a clinically-apparent dystonia, but rather spasticity of the left leg, since stimulation of only a small amplitude was applied. The reporter stated that switching off the right-sided stimulation yielded no benefit with respect to the plc, suggesting that bilateral pathology was therefore not mandatory to provoke plc. One month later, the patient reported a reappearance of the pseudobulbar symptoms during housework. The patient reportedly presented with right-sided hemidystonia and showed identical pseudobulbar symptoms as previously, including dysarthria, dysphagia and plc. The reporter stated that an assessment of the ins revealed that the high-frequency stimulation was again provoking the symptoms. The patient stated that stimulation had not been restarted by herself or a physician. The patient stated that the symptoms had suddenly reappeared while leaning over the television screen, which was in stand-by mode. The reporter stated that the magnetic field of the television interfered with the stimulator and switched it on again. It was noted that the magnetic switch of the stimulator had not been inactivated and the amplitude of the left-sided stimulation parameters had not been set to zero when stimulation had been turned off. It was noted that the amplitude of the right stimulation contact was still set to zero. The reporter stated that after deactivating the stimulator, the pseudobulbar signs promptly disappeared again. 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=3466513
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« Reply #56 on: December 07, 2013, 07:22:11 AM »

Model Number 37601
Event Date 10/03/2013
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), product type extension product id 3708660, serial# (b)(4). Product type extension. (b)(4).

 
Event Description
It was reported that there was a "misdirection of the electrode around the implantable neurostimulator (ins)". It was stated that this "necessitated medical or surgical intervention". X-rays had been taken that revealed a "dislocation of electrode" on (b)(6)-2013. The signs or symptoms were reported to be "pressure, pain above the ins location when moving the right arm, and pain in the head was growing". It was noted that there was no inflammation. Additional information received reported that there was "stimulator dislocation, loop of extension cable". It was not clear what the problem was. It was stated that this was "part of ongoing, but reduced complaint could still resolve as postoperative pain". That was also not clear. It was stated that this was "ongoing with no further action needed". It was reported that the device was surgically revised on (b)(6)-2013. It was noted that the stimulator and the extension were revised. X-rays were taken that revealed "loop of cable". It was not clear what this meant. It was stated that this event was possibly related to the implant procedure and it was related to the device or therapy. Signs or symptoms were reported as "pain in the stimulator and extension cable right neck". It was stated that this event resulted in "in-patient hospitalization". Additional information received reported that the extension migrated or dislodged.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447275
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« Reply #57 on: December 08, 2013, 04:57:10 AM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Disability,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. Concomitant products: product id neu_unknown_lead, lot # unknown, product type lead; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id neu_unknown_lead, lot # unknown, product type lead; product id neu_ins_stimulator, serial # unknown, product type implantable neurostimulator; product id 7498, lot # unknown, product type extension. (b)(4).

 
Event Description
Mazzone, p. , brown, p. , dilazzaro, v. , stanzione, p. , oliviero, a. , peppe, a. , santilli, v. , insola, a. , altibrandi, m. Bilateral im plantation in globus pallidus internus and in subthalamic nucleus in parkinson's disease. Neuromodulation : journal of the international neuromodulation society. Summary: deep brain stimulation (dbs) of the subthalamic nucleus (stn) and of the pars interna of globus pallidus (gpi) is used to improve parkinsonian symptoms and attenuate levodopa-induced motor complications in parkinson¿s disease (pd) (dbs for pd study group, 2001). It is still not clear what the best anatomic structures to stimulate are or what the physiologic effects of dbs are. Most of the studies regarding dbs for parkinsonian symptoms have been conducted in patients with stn implantation, and these studies reported significant improvement in motor function with a relatively low rate of complication. The large experience of ablative surgery associated with the dbs experience of some groups worldwide indicate that gpi is a possible and very promising target for the management of parkinsonian symptoms. Surgical procedures have become safer and it is now possible, in selected cases, to target both structures in the same patient by means of the stereotactic system, ¿3p maranello¿ ((b)(4)). Using this system we were able to evaluate the clinical effects of simultaneous stimulation of both stn and gpi as well as evaluate the effects of isolated stimulation of each target. As it is known that there is a high intersubject variability of dbs, it seems relevant to test all different combinations of dbs in the same patient. We assessed the effects of dbs in 13 cases of pd, immediately after (30 min) stimulation and during chronic stimulation (weeks or months). Patients fell into two groups. The first (n= 7) responded to both gpi and stn stimulation equally. The second group (n= 6) was preferentially stimulated with only one target (stn = 5, gpi = 1). There was a good reduction in levodopa treatment following surgery. Most patients remained were chronically treated with bilateral stimulation of both targets. We conclude that dbs of stn and gpi was effective, with most patients treated chronically with both targets stimulated. Reported events: one patient experienced a hemorrhagic episode requiring surgical evacuation due to an arteriovenous malformation, which had not been detected during diagnostic neuroradiologic evaluation. The reporter stated that the patient suffered permanent right hemiparesis. One patient did not have correct positioning of electrodes on one side according to a postoperative mri. The reporter stated that the patient experienced somnolence, indifferentism, and a psychiatric disorder which were related to the wrong positioning of the left subthalamic electrode. It was noted that the electrode was repositioned later with the disappearance of these symptoms. Eight (8 ) patients experienced permanent weak phonation directly related to activation of deep brain stimulation (dbs). It was noted that these dbs related side effects were fundamentally linked to dbs of the subthalamic nucleus (stn), especially in patients with monopolar stimulation. The reporter stated that the side effects were not increased with simultaneous stimulation of both the stn and the globus pallidus internus (gpi). 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=3493031
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« Reply #58 on: December 09, 2013, 06:01:46 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/24/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
The actual date of death was not provided. This date is based on the date of publication of the article. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant products: product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387-40, lot# unknown, product type lead; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator. (b)(4).

 
Event Description
Li, d. , cao, c. , zhang, j. , zhan, s. , chen, s. , sun, b. Subthalamic nucleus deep brain stimulation for parkinson's disease: 8 yearsof follow-up. Translational neurodegeneration. 2013;2(1):11. Doi: 10. 1186/2047-9158-2-11. Summary: the short-term benefits of bilateral stimulation of the subthalamic nucleus (stn) in patients with advanced parkinson¿s disease (pd) are well documented, but long-term benefits are still uncertain. The aim of this study is to evaluate the outcome of 8 years of bilateral stn stimulation to pd patients. In this study, 31 consecutive pd patients were treated with bilateral stn stimulation. Their functional status was measured using the activities of daily living section of the unified parkinson¿s disease rating scale (updrs-adl) at drug on (with medication) and drug off (without medication) states preoperatively and at 1, 5, and 8 years postoperatively. In addition, levodopa equivalent doses and stimulation parameters were also assessed. After 8 years of stn stimulation, the updrs-adl scores were improved by 4% at drug off status (p > 0. 05) and 22% at drug on status (p <(><<)> 0. 05) compared with baseline; the levodopa daily doses were reduced by 28% = (p <(><<)> 0. 05) compared with baseline; the stimulation voltage and pulse width w ere not changed, but the stimulation frequency was decreased remarkably compared with the 5 years of follow-up. Adverse events were observed in 6 patients, including misplacement of the electrode and skin erosion requiring further surgery. All events were resolved without permanent sequelae. 2 patients died of aspiration pneumonia 6 and 7 years after surgery. The marked improvement in updrs-adl scores were still observed after 8 years of bilateral stn stimulation with medication. Reported events: two patients had skin erosion in pocket site. The stimulators were repositioned. All events were resolved without permanent sequelae. Four patients had malposition of the electrodes, which was revealed by ineffectiveness of stimulation and mri. The electrodes were adjusted to alleviate the symptoms. All events were resolved without permanent sequelae. One patient died of aspiration pneumonia due to swallow disorders 6 years after surgery. One patient died of aspiration pneumonia due to swallow disorders 7 years after surgery. Unidentified number of patients developed axial symptoms suchas swallow, speech and gait disorders. As a result, the stimulation was reduced further to improve balance and speech functions, especially in some bradykinesia or rigidity dominated patients. 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=3202457
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« Reply #59 on: December 09, 2013, 06:04:35 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/01/2011
Event Type  Death   Patient Outcome  Death
Event Description
Servello, d. , sassi, m. , pacchetti, c. , mancini, f. , gaeta, m. , ricci, c. , menghetti, c. , porta, m. Hemorrhagic and repositioning risk factors related to intraoperative multitrack microrecording on a large series of patients treated for deep brain stimulation. Neurosurgery quarterly. 2011;21(3):194-198. Summary: we analyzed this complication in relation to simultaneous multitrack microrecording (mer) as observed in our experience. The possible contribution of mer to the precision of the dbs procedure was also evaluated. From october 1996 to january 2010, 532 consecutive procedures were performed at the unit of functional neurosurgery, division of neurosurgery irccs galeazzi in milan, and at the institution of besta irccs in milan by 2 of the authors (d. S. And m. S. ), on a total number of 272 patients. Findings: ischaemic/hemorrhagic complications were documented in 9 patients (1. 6%), and 5 of them presented with a neurological syndrome. Overall mortality was 3 patients (1. 1%), and was correlated with intracranial hemorrhage in 1 patient. Repositioning of incorrectly positioned electrodes was deemed necessary in 26 procedures (4. 9%) on 23 patients (8. 4%). Conclusions: although no consistent association was documented between the use of simultaneous intraoperative multitrack mer and hemorrhage, a statistically significant association was recorded between an incorrect positioning of the definitive leads, as reported in the postoperative magnetic resonance imaging controls or at the intraoperative computed tomographic (ct) scans, and the lack of "intraoperativemer". Dbs proves to be a safe and effective procedure even for novel indications. In our experience, no association was found between hemorrhagic risk and simultaneous multitrack mer. Reported event: 1 patient presented with a decreased level of consciousness;a left-sided frontal intraparenchymal hematoma of 2 cm m aximum diameter was reported at the postoperative mri checkup, whereas the immediate postoperative ct scan of the brain was normal. Hematuria was subsequently reported, and multiorgan failure together with acute renal insufficiency lead to the patient¿s death 1 month after surgery, whereas neuroradiologic checkups documented a progressive "readsorption" of the hematoma. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Concomitant product: product type lead. (b)(4).

 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that death was correlated with intracranial hemorrhage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3207205
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