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Author Topic: Deep brain stimulator - Short Circuit  (Read 54190 times)
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dennis100
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« on: November 05, 2013, 11:53:24 PM »

Model Number IPGNEURO
Device Problem Electrical shorting
Event Type  Malfunction  
Event Description

It was reported a dbs patient being treated for (b)(6) disease had been having the leads "short circuit". The therapy had worked well in mitigating the symptoms until the issue with the leads. The patient was scheduled to undergo surgery over thanksgiving.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1950335
« Last Edit: December 05, 2014, 11:52:06 PM by dennis100 » Logged
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« Reply #1 on: November 05, 2013, 11:53:50 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Additional information was received from the physician that reported there was a short circuit between contact 0 and 2, which caused the actual stimulation field around contact 1 to become narrower. The patient was reprogrammed from contact 2+ to 3+, but symptoms remained unchanged. During follow up, it was determined that the patient's symptoms were not related to the short circuit.
 
Manufacturer Narrative

 
Manufacturer Narrative

Product id: neu_unknown_lead, serial# unknown, product type: lead. Product id: neu_unknown_lead, serial# unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. D: patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 3. The patient had bilateral stimulation of the internal globus pallidus (gpi), and had a short circuit on the left side with electrodes 0-2. The patient experienced eyelid opening apraxia and neck dyskinesia. Impedance measurements were less than 50 ohms. Initial polarity settings were 1-2+, altered to 1-3+ with no change in symptoms. The cause of the short circuit was not identified. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860923

« Last Edit: February 04, 2014, 03:07:53 AM by dennis100 » Logged
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« Reply #2 on: November 05, 2013, 11:54:11 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Malfunction  
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 2. The patient had bilateral stimulation of the subthalamic nucleus (stn). The left lead had a short circuit with electrodes 0-3. Impedance measurements were less than 50 ohms. During the 5 years before the short circuit was identified, the patient experienced wearing off of therapeutic effect and freezing and propulsive gait during the off phase of medication, causing him to visit the hospital. Gait freezing may have resulted from a limited potential field due to the 2 anodes being involved in the short circuit. The patient also exhibited marked dysarthria and drooling. The patient's left implant delivered bipolar stimulation using contact 1 as a cathode and contact 3 as an anode. Therapy impedance was 794 ohms. Examination of system impedance revealed a short between contacts 3 and 0. Contact 0 was 6. 5mm under the midcommissural plane, suggesting a location in the ventral area of the stn. Altering the electrode setting to a unipolar stimulation using contacts 1 and 2 as cathodes led to the subjective alleviation of freezing and propulsion, but the sense of wearing off was not subjectively altered. These findings suggested that a short circuit between contacts 3 and 0 unexpectedly had limited the spread of the therapeutic potential field around contact 1. Short circuits were not suggested in radiographic examinations and were associated with no open circuits in a unipolar configuration. The cause of the short circuit was not identified.
 
Manufacturer Narrative

Product id: neu_unknown_lead, serial#: unknown, product type: lead; product id: neu_unknown_lead, serial#: unknown, product type: lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator: model 7424 or 7426 and lead model: 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860888

« Last Edit: February 04, 2014, 03:09:50 AM by dennis100 » Logged
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« Reply #3 on: November 05, 2013, 11:54:35 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4).
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Jns112073. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impendence at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients (8. 9% of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits (2. 5%) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case 1. The patient had bilateral stimulation of the subthalamic nucleaus (stn). The patient had a short circuit on the right side with electrodes 2-3. Symptoms included "wearing off" and dyskinesia. Impedance measurements were less than 50 ohms. Initial polarity settings were 1-2+, altered to 1-case+ with no change. There was no open circuit. Cause of the short circuit was not identified.
 
Manufacturer Narrative

Product id neu_unknown_lead, serial# unknown, product type lead; product id neu_unknown_lead, serial# unknown, product type lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
Event Description

Additional information was received from the physician that reported the stimulation field around contact 1 became 'narrower. ' the patient was reprogrammed to not use contacts 2 and 3, but the patient's symptoms remained the same. It was also reported that the patient developed an infection at the bur hole of the cranium and the lead was explanted in (b)(6) 2012. The patient's symptoms were gradually aggravated and the dbs lead was reimplanted (b)(6) 2012. The patient's symptoms were noticeably alleviated by stimulation using contact 2 instead of contact 1.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860758

« Last Edit: February 04, 2014, 03:10:18 AM by dennis100 » Logged
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« Reply #4 on: November 05, 2013, 11:54:59 PM »

Model Number NEU_INS_STIMULATOR
Event Date 08/07/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Additional information was received from the physician that reported the contacts that had short circuited were not used for the patient's stimulation. The patient's symptoms were due mainly to the positioning of the lead and it was noted there was no causal relationship between the short circuit and the patient's symptoms.
 
Event Description

Literature: samura, k. , miyagi, y. , okamoto, t. , hayami, t. , kishimoto, j. , katano, m. , kamikaseda, k. Short circuit in deep brain stimulation. J. Neurosurg. 2012;117(5):955-961. Doi: 10. 3171/2012. 8. Summary: the authors undertook this study to investigate the incidence, cause, and clinical influence of short circuits in patients treated with deep brain stimulation (dbs). After the incidental identification of a short circuit during routine follow-up, the authors initiated a policy at their institution of routinely evaluating both therapeutic impedance and system impedance at every outpatient dbs follow-up visit, irrespective of the presence of symptoms suggesting possible system malfunction. This study represents a report of their findings after 1 year of this policy. Implanted dbs leads exhibiting short circuits were identified in 7 patients ((b)(4) of the patients seen for outpatient follow-up examinations during the 12-month study period). The mean duration from dbs lead implantation to the discovery of the short circuit was 64. 7 months. The symptoms revealing short circuits included the wearing off of therapeutic effect, apraxia of eyelid opening, or dysarthria in 6 patients with parkinson disease (pd), and dystonia deterioration in 1 patient with generalized dystonia. All dbs leads with short circuits had been anchored to the cranium using titanium miniplate s. Altering electrode settings resulted in clinical improvement in the 2 pd cases in which patients had specific symptoms of short circuits ((b)(4)) but not in the other 4 cases. The patient with dystonia underwent repositioning and replacement of a lead because the previous lead was located too anteriorly, but did not experience symptom improvement. In contrast to the sudden loss of clinical efficacy of dbs caused by an open circuit, short circuits may arise due to a gradual decrease in impedance, causing the insidious development of neurological symptoms via limited or extended potential fields as well as shortened battery longevity. The incidence of short circuits in dbs may be higher than previously thought, especially in cases in which dbs leads are anchored with miniplates. The circuit impedance of dbs should be routinely checked, even after a long history of dbs therapy, especially in cases of miniplate anchoring. Reported event: case (b)(4). The patient had bilateral stimulation of the internal globus pallidus (gpi), and had a short circuit on the left side with electrodes 0-2. Impedance measurements were less than 50 ohms. The patient experienced dystonia deterioration. Initial polarity settings were 1-3+ altered to 1-3+ with no change in symptoms. An mri revealed that the lead was located in too anterolateral a position, suggesting stimulation of the globus pallidus externus. The lead was replaced and repositioned in the gpi with moderate alleviation of the patient's dystonia. The cause of the short circuit was not identified.
 
Manufacturer Narrative

(b)(4).
 
Manufacturer Narrative

Product id neu_unknown_lead, serial # unknown, product type lead; product id neu_unknown_lead, serial # unknown, product type lead. The actual event dates were not provided. This date is based on the date of publication of the article. Patients were implanted with implantable neurostimulator model 7424 or 7426 and lead model 3387 or 3389. It was unknown which models this particular patient was implanted with. (b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2861892
« Last Edit: February 04, 2014, 03:11:23 AM by dennis100 » Logged
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« Reply #5 on: November 06, 2013, 11:47:04 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 #6 on: November 07, 2013, 08:34:23 PM »

Type of device: pulse generator
extension kit (left)
extension kit (right)
lead
lead, deep brain stimulator
Device brand name:    
Activia PC
Activa PC
Device manufacturer's name:    
Medtronic Neuromodulation
Date of this report: 12/22/2009
(mm/dd/yyyy)    

Describe the event or problem: Stereotactic placement of bilateral sub-thalamic nuclear DBS leads with micro-electrical recordings was completed. Placement of Activa PC generator and extension kits was done 1 week later. Approximately 2 months later our facility received a call from the provider office to report a short circuit with the impedance off. Configuration of programming changed so that those 2 circuits are not being used. This is the 3rd such problem our facility has seen in the past 6 months.

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=55851


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« Reply #7 on: December 06, 2013, 01:22:42 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 3387s-40, lot# v635198, implanted: (b)(6) 2011, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

 
Event Description
It was reported that low impedances of 8 ohms were measured on electrodes 0 and 1. It was noted the patient was having implantable neurostimulator (ins) replacement surgery and was receiving benefit from stimulation without side effect. The reporter stated the patient¿s healthcare professional decided not to troubleshoot the electrode and extension. Additional information received reported the cause of the short circuit was not determined. It was noted the date of the ins replacement surgery was (b)(6) 2013. 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=3446395
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« Reply #8 on: January 03, 2014, 12:34:34 AM »

Model Number 3387
Device Problems Replace; Tears, rips, holes in device, device material; Wire(s), breakage of
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Preliminary device analysis results were not available at the time of this report. A follow-up report will be sent when product eval is complete.

 
Event Description
The rep reported that during the stage ii implant procedure, when the temporary cover was removed from each dbs lead, the number zero contact was compromised and lead wires were exposed. With difficulty, the physician connected both compromised leads to the extension; impedance readings in recovery were acceptable. The system was activated and the pt initially did well. A few months later, when therapy benefit stopped, a system check showed high impedance readings from the right-side components and a short circuit was detected from left-side components. Both leads were replaced and were returned to the mfr for analysis for suspected wire breakage. See mfr report number 6000153200701223.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=929864
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« Reply #9 on: January 03, 2014, 06:59:42 PM »

Model Number 7482
Device Problems Device remains implanted; Wire(s), breakage of
Event Type  Malfunction   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
Patient reported to the mfr on (b)(6) 2006 they were diagnosed with open wire (extension), as shown by x-ray exam. The patient provided additional information to the mfr on (b)(4) 2007 regarding symptoms that included rigidity, difficulty walking, and tightness felt over the battery for the past two months. The patient also indicated they were scheduled for follow up with the hcp during (b)(6) 2007 for an internal system check because the physician is concerned that an open or short circuit is possible. The date x-ray films were obtained and prior date of consult with the physician was not reported. No report of device explantation has been received. The product was implanted in (b)(6) 2006. It is unknown if both extension products were affected. Additional information has been requested from the hcp. See mfr report number 2649622-2007-00177.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2999653
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« Reply #10 on: January 05, 2014, 02:02:51 PM »

Model Number 3389
Device Problems Unknown (for use when the device problem is not known); Implant, reprogramming of
Event Date 10/11/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The manufacturer representative reported a problem with impedances; therapy impedances around 600-700 with current of 200ua which indicate a short. The device was programmed around this particular pair of electrodes that had a high current reading. Refer to medwatch report #6000153200704304.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962078
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« Reply #11 on: January 05, 2014, 02:04:22 PM »

Model Number 3387
Device Problems Device remains implanted; Low impedance; Implant, reprogramming of
Event Date 10/25/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported the patient experienced intermittent right leg cramping. Dystonia, dyskinesia and pain. Further investigation revealed a short circuit depleted the neurostimulator prematurely. Impedances on electrodes 0 and 1 were 59 ohms. The neurostimulator and one extension were replaced; impedances still indicated a short circuit (58 ohms and 301 ua). The representative programmed around the electrodes, using electrodes 2 and 3 instead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=971917
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« Reply #12 on: January 05, 2014, 02:05:28 PM »

Model Number 3389
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 11/20/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported, impedances >2000 ohms on all or some of the unipolar pairs. The pt is implanted bilaterally. The hcp used the same neurostimulator on different sides of the body which gave the hcp different battery readings and different problems. On the left side impedance readings indicated a short circuit; the right side appeared more normal. The caller also reported impedances <250 ohms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=969294
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« Reply #13 on: January 08, 2014, 04:04:00 PM »

Model Number 3387IES
Device Problems Device remains implanted; Low impedance
Event Date 08/27/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that during ins replacement impedance readings indicated that there was a short circuit, noting low impedance and high amplitude. The combination of 0 and 1 had an impedance <50 ohms and when 3 was removed the impedance was <50 ohms. The hcp noted that he was going to replace the pt's ins despite that there was a short circuit. The hcp understood the situation, but continued with the ins replacement. It appeared that the short was present before the replacement surgery. The short appears to be at the connection of the dbs lead and the extension. The patient did not experience any symptoms as a result of this event. Add'l information has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=919951
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« Reply #14 on: January 08, 2014, 04:04:48 PM »

Model Number 7426
Device Problems Shock, electrical; Device remains implanted; Implant, reprogramming of
Event Date 07/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The mfr rep reported the patient complained of bilateral intermittent shocking, up to 75 times a day, in various locations throughout the body. Troubleshooting was performed. The mfr suggested shutting off the device for a few days to see if the shocking subsided. The patient was turned off on a friday. The shocking/jolting sensations decreased to 3 or 4 times a day. The patient was reprogrammed the following monday and the device was turned back on. The patient stated the shocking/jolting sensation occurred less often. The hcp stated the patient is experiencing shocking less than five times a day. X-ray films looked good. Device interrogation suggested a possible short. The patient will be scheduled for more detailed x-rays. Refer to medwatch report #3004209178-2007-02884.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=910592
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« Reply #15 on: January 08, 2014, 04:05:37 PM »

Model Number 7426
Device Problems Circuit Failure; Replace; Improper or incorrect procedure or method; Implant, reprogramming of; Device Issue
Event Date 10/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient had required emergency replacement surgery; the dbs system was replaced for "equipment failure" (details were not provided), the spouse had indicated that the patient experienced "additional trauma" from the event; no symptoms were reported. The hcp had indicated to the representative that one lead had migrated; "the dbs lead pulled out (moved 10-20mm), which could have been activity related" (no details or dates were given). The representative had been present for initial programming; no issues were noted and the patient had indicated that symptoms improved. The representative followed-up with the physician; subsequent reprogramming had occurred "for a month or so" by the hcp (dates were not reported). The representative indicated there had been an open circuit. Impedance readings had revealed a "short" and the lead was replaced, it was unknown why the ipg was also replaced. The user facility had disposed of explanted product, the devices would not be returned for analysis. The patient outcome had initially been good with no subsequent change in status reported. Refer to mfr reports #6000153-2007-02723 and 6000153--2008-00930.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1004046
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« Reply #16 on: January 09, 2014, 09:23:49 AM »

Model Number 3389
Device Problems Circuit Failure; Device remains implanted
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The representative reported a problem with delivery of dbs therapy (exact event date unk); there had been a loss of therapeutic benefit, whether stimulation was turned off or on. It was unk if the patient had suffered a fall or other trauma; results of x-ray exam had revealed the left-sided lead had fractured wires with impedance readings greater than 2000 ohms on all or some unipolar pairs. The connection point between the left-sided and extension appeared to have slipped (dislodged), downward from the neck area. The right-sided lead had an apparent short-circuit between electrode numbers zero and three; impedance readings showed less than 250 ohms. Options of reprogramming stimulation therapy and surgical revision would be considered. Additional information has been requested from the physician. Refer to mfr report #6000153200800170.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979278
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« Reply #17 on: January 09, 2014, 01:57:14 PM »

Model Number 3389S
Device Problems Electrode contact(s), problem with; Material frayed; High impedance; Insulation, detached; Device remains implanted; Repair; Tears, rips, holes in device, device material
Event Date 04/22/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the number three electrode contact had appeared frayed or damaged after removal of the accessory lead cap cover during the case. Exposed wires seen in the area contacted by the cap and the distal tip material had appeared stretched. The lead had separated easily from the temporary cap during the stage ii procedure; the surgeon had followed manufacturer instructions for use. The lead damage had been attributed to use of the temporary lead cap. The lead was subsequently inserted into the extension and the system connected after the surgeon cut-off the #3 contact in order to attach the extension and connect the system. Post-operative impedance readings obtained showed all unipolar electrode pairs were between 830 and 840 ohms, at 37 to 39 usec and a short circuit was suspected. Add'l impedance data obtained at 3v, showed values in the mid-500 range. No pt symptoms or injury was reported.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1052528
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« Reply #18 on: January 09, 2014, 05:08:18 PM »

Model Number 7482
Device Problem Low impedance
Event Date 05/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient experienced a loss of therapeutic effects. X-rays showed a possible short circuit in the extension (date not reported). Impedances were less than 50 ohms on electrodes 2 and 3. The device was not reprogrammed due to side effects (not specified). The hcp planned to remove the extension. 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=1058565
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dennis100
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« Reply #19 on: January 09, 2014, 05:09:12 PM »

CRIMINAL
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« Reply #20 on: January 12, 2014, 05:19:24 PM »

Model Number 3387
Device Problems Device remains implanted; Low impedance; Implant, reprogramming of
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that the pt had a buzzing sensation on top of her head, on the left side of her face, and around her nose area. Sometimes, it increased in sensation. There was no known accident or incident related to the buzzing, but it was approx 2 months after a new neurostimulator was implanted on the right side and also around the time of a known lead short on 0-3. The hcp programmed around the short, but the buzzing continued. Palpation did cause the stimulation to change. Palpation also resulted in changes in sensation, when the stimulation was turned off. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1021227
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« Reply #21 on: January 12, 2014, 05:21:06 PM »

Model Number 3389
Device Problems Lead(s), breakage of; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: tabbal/safety and efficacy of subthalamic nucleus deep brain stimulation performed with limited intraoperative mapping for treatment of parkinson's disease 2007/61/3/119-27. This single-center study implanted 110 patients with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for the treatment of parkinson's disease. The objective of the study was to establish the safety and efficacy of bilateral stn-dbs performed during an expedient procedure with limited intraoperative mapping. The investigators used t2-weighted magnetic resonance imaging guidance to target the stn. Adverse events are reported. One pt required a lead replacement due to a short-circuit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019681

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« Reply #22 on: January 13, 2014, 02:36:10 AM »

Model Number 3389S
Device Problems Circuit Failure; Electrode contact(s), problem with; Device remains implanted; Tears, rips, holes in device, device material; Low impedance
Event Date 04/15/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that the number three electrode contact had appeared frayed or damaged after removal of the accessory lead cap cover during the case. The lead had separated easily from the temporary cap during the stage ii procedure; the surgeon had followed mfr instructions for use. The lead damage had been attributed to use of the temporary lead cap. The lead was subsequently inserted into the extension and the system connected. Post-operative impedance readings obtained showed all unipolar electrode pairs were between 830 and 840 ohms, at 37 to 39 usec. Add'l impedance data obtained at 3v, showed values in the mid- 500 range, and a short circuit was suspected. No pt symptoms or injury was reported. Add'l info has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047656
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« Reply #23 on: January 13, 2014, 09:38:09 AM »

Device Problem Low impedance
Event Date 03/28/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported intraoperative impedance readings did not match post-operative results. Impedance readings of <250 ohms were reported. Post-operative results indicated a short with connections 1 and 2 only; however, an impedance test showed these connections were fine. No pt symptoms were reported. The device was programmed around the "shorted" connection. The pt had good stimulation results without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034892
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« Reply #24 on: January 13, 2014, 10:16:39 AM »

Model Number 3387
Device Problems Circuit Failure; Pipette, failure to aspirate
Event Date 04/01/2008
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that subsequent to programming using electrode number three, impedance readings were <250 ohms, and an open (short) circuit was suspected. No pt symptoms were reported. Additional info has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1036117
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« Reply #25 on: January 14, 2014, 01:09:17 PM »

Model Number 7428
Device Problems High impedance; Other (for use when an appropriate device code cannot be identified)
Event Date 06/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt never had therapeutic effect after a new lead and extension implant. The lead was placed in the ventral intermediate thalamus. Bipolar impedances on electrode combinations 4-6, 5-7, and 6-7 were 3620 ohms and less than 15 microamperes. The hcp planned on opening the extension-lead site (and extension-implantable neurostimulator site if needed) to take apart, clean the connections and recheck impedances. The hcp later reported that a fluid short was diagnosed. A follow-up report will be submitted if additional info becomes available.

 
Manufacturer Narrative
Evaluation results: it is unk where the fluid short occurred. Fluid short.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1074720
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« Reply #26 on: January 14, 2014, 01:09:47 PM »

Model Number 7426
Device Problems Lead(s), breakage of; Replace; Wire(s), breakage of; Low battery
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
Lead and/or extension breakage was reported. The lead and/or extension was "shorting out". The battery was depleted.

 
Manufacturer Narrative
The neurostimulator, lead and extension were returned for analysis. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083469
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« Reply #27 on: January 14, 2014, 01:10:14 PM »

Model Number 7426
Device Problems Low impedance; Implant, reprogramming of
Event Date 07/31/2008
Event Type  Malfunction 
Event Description
After battery replacement, an impedance of 50 ohms and current of 575 microamperes was discovered, indicating a short circuit. The hcp was able to program around the short. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147379
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« Reply #28 on: January 14, 2014, 08:17:26 PM »

Model Number 7426
Device Problems Premature discharge of battery; Replace
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis revealed no significant anomalies of the implantable pulse generator. The epoxy bond between the hybrid circuit and the battery terminal was broken. The electrical connections were intact; there was no impact to device performance. There were no electrical anomalies with the hybrid circuit that would cause a premature depletion. The implantable neurostimulator battery was found to be depleted. The difference between the actual battery life and the expected battery life may be related to the breached depression in the insulation on the extension to the #0 and #1 conductors.

 
Event Description
The patient felt the stimulation from the deep brain stimulator was unstable. The hcp suspected a short in the extension or early battery depletion. Prior to replacement, the hcp checked impedances because he suspected damage of the lead or extension (results not reported). The pulse generator and the extension were explanted and replaced. Intraoperatively there was no evidence of a short in the extension. The lead remained implanted. The hcp reported the pt outcome as 'recovered'.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1091506
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« Reply #29 on: January 14, 2014, 08:17:58 PM »

Model Number 7428
Device Problems Premature discharge of battery; Replace; Low impedance
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient's dbs device was reading unexpectedly low battery voltages. Impedance readings were <250 ohms. A short circuit was suspected. The patient had reportedly fell. Battery replacement and lead/extensions revision were being considered. The patient was seen by their following physician two weeks later. The patient was scheduled for battery replacement 2008. The leads and extensions would be checked during the replacement procedure to see if they needed to be revised as well. No patient symptoms were reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216287
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