Pages: 1 [2] 3 4  All   Go Down
Print
Author Topic: Deep brain stimulator - Short Circuit  (Read 51924 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #30 on: January 14, 2014, 10:37:14 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Unknown (for use when the device problem is not known)
Event Date 06/23/2008
Event Type  Malfunction 
Manufacturer Narrative
Short circuit.

 
Event Description
The patient experienced a loss of therapeutic effect, unrelated to a known incident or accident. The patient was seen by his hcp 3 days later who discovered a short on electrodes 2 and 3 (impedance not reported). The patient status was reported as 'unknown'; he was not able to withstand surgery. Additional information has been requested. A follow-up will be submitted if additional information becomes available.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172903
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #31 on: January 17, 2014, 08:02:46 PM »

Model Number 7428
Device Problems Replace; Other (for use when an appropriate device code cannot be identified)
Event Date 01/06/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported that the lead was replaced in early 2009, due to a short; it was unclear which lead was replaced. 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=1317777
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #32 on: January 17, 2014, 10:33:52 PM »

Model Number 7428
Device Problem Premature discharge of battery
Event Date 02/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the neurostimulator showed end of life even thought the programmed settings were within normal limits (no extra current was drawn from stimulator on purpose). The patient also experienced return of symptoms. Further troubleshooting was being considered to find out if there was a short circuit somewhere in the system causing premature battery depletion. No patient treatment or outcome was reported. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1349724
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #33 on: January 17, 2014, 10:37:04 PM »

Model Number 7426
Device Problem Device damaged prior to use
Event Date 08/15/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit. Analysis revealed the stimulator was functionally ok. Lead: multiple conductors wires were stretched; continually was acceptable. Extension: the majority of the extension body and outer insulation was twisted; the extension was functionally ok.

 
Event Description
It was reported the patient began having low voltage side effects at all contacts after a year of therapy. The physician suspected a short circuit between the leads. The problem was fixed by replacing the lead extender and battery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324319
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #34 on: January 18, 2014, 05:46:22 AM »

Model Number 7426
Device Problem Low impedance
Event Date 03/30/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
It was reported that the patient's deep brain stimulation system (dbs) had a possible short circuit. Upon connecting the leads to the implantable neurostimulator (ins), the physician noted that the 0 and 3 contacts had and impedance of <50 ohms. The system was disconnected and cleaned for possible fluids that may have created a short circuit. After cleaning the impedances for the 0 and 3, contacts remained low; however, all other contacts were within normal range. The device was not activated. Reprogramming of the device will be performed in a neurology clinic at a later date. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425041
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #35 on: January 19, 2014, 12:30:34 AM »

Model Number 7426
Device Problems Low impedance; Low battery
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
Bipolar impedances were 135 ohms on electrode combination 0-3, indicating a short. This was not a known device problem. The implantable neurostimulator was programmed to use electrodes 1-3. The patient was and still is receiving adequate stimulation. The implantable neurostimulator batteries were beginning to deplete. Please see mfr. Report # 3004209178-2009-03086.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1427352
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #36 on: January 19, 2014, 12:31:33 AM »

Model Number 37601
Device Problems High impedance; Replace
Event Date 01/28/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Final device analysis of the implantable neurostimulator revealed that there was no anomaly found - normal device function. Final device analysis of one extension revealed no significant anomalies; the extension was ok, but the insulation was melted/cut. Final device analysis of the second extension revealed a reliability non-conformance. There was a short between circuits (dry conditions). The connector area was intact; however, there was an intermittent short between circuits under the #2 connector. There was an intermittent short between the #2 and #3 conductors under the #2 connector. The cut ends of the #2 conductor were suspected to have shorted with the #3 conductor under the #2 connector.

 
Event Description
It was reported that the hardware was defective. The impedance was too high. There was no stimulation effect. The lead was replaced. The pt outcome was reported as ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409818
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #37 on: January 20, 2014, 01:47:55 AM »

Model Number 3387S LEAD
Event Date 12/15/2009
Event Type  Malfunction 
Event Description
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564723
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #38 on: January 20, 2014, 01:50:00 AM »

Model Number 37612
Device Problems Degraded; Low impedance; Electrical shorting
Event Date 01/01/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
The pt had to recharge frequently, for three hours every two days. Impedance for pair 1, 2 was 159 ohms and "out of regulation" messages were displayed. A short was confirmed. Ct revealed that one of the wires had "thinned" though it was not possible to determine if this was the cause of the short. It was possible to program around the short and the pt was receiving benefit. The device held charge at a more reasonable level; nothing was explanted or replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1565728
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #39 on: January 22, 2014, 02:53:47 AM »

Model Number 7426
Device Problems High impedance; Wire(s), breakage of; Electrical shorting
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4). This report is being submitted late due to a delay by a mfr employee. Training is in place.

 
Event Description
The pt reported jolting and pain in the faces. Impedance testing, x-rays and reprogramming were tried without success. It was reported that impedances were high and also that there were short circuits; it was determined that the lead was probably broken. The battery was also depleted, no longevity calculations were done; it was considered normal depletion. The system was replaced. The pt was reported to be doing much better.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614575
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #40 on: January 22, 2014, 08:28:14 AM »

Model Number 37601
Device Problems Bent; Low impedance
Event Date 02/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that during stage 2 implant, low impedances between 50-150 ohms were noted on 10 and 11 contacts and shorted at <40 ohms. An inspection of the lead revealed that the distal portion was bent. It may have been due to screwing on of the lead cap during stage 1, but was most likely caused in retrieving the lead under the skin during stage 2. Stage 2 implant proceeded as normal and patient was closed up. The patient did not turn stimulation on until 2 weeks following implant. The patient was seen on (b) (6) 2010, for initial programming. The device was interrogated and impedance readings confirmed the short between contacts 10 and 11. In the initial programming session all contacts were explored for their therapeutic benefit. Contacts 10 and 11 did have therapeutic benefit, however, the optimal configuration for most beneficial effects with minimal side effects was 8+, 9-. This initial programming session resulted in settings of 8+, 9-, 2. 0 volts, 90 micro amps, and 185 hz. The therapy impedance reading was 1617 ohms with 1. 237 micro amps. The patient and physician were satisfied with the results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637580
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #41 on: January 22, 2014, 08:51:23 AM »

Model Number 7426
Device Problems Premature discharge of battery; Communication or transmission issue; Electrical shorting
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced a loss of therapy efficacy. Approx 3 weeks later, the pt was seen in clinic. No telemetry could be established between the deep brain stimulator and the physician programmer. It was determined that there was a short in one of the electrode combinations. This combination was inadvertently programmed to be used in therapy, causing premature deep brain stimulator battery depletion. The neurostimulator was replaced. Afterward, the pt's therapy resumed to a satisfactory level.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614500
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #42 on: January 22, 2014, 08:52:04 AM »

Model Number 7428
Device Problems Premature discharge of battery; Electrical shorting
Event Date 01/12/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The battery reached end of life after two years and seven months of use. The expected life was 3. 5 years. The programming printouts were reviewed and the highest stimulation settings were one cathode per channel and in both channels: 2. 8v, 90mcs, 135hz. The ipg was replaced. It was then noticed that both of the extensions had short-circuited; they were also replaced. The removed extensions were thrown away and will not be returned for analysis. The pt outcome was reported as "resolved".

 
Manufacturer Narrative
(b) (4). Final device analysis was not available at the time of this report. A follow-up medwatch report will be sent when the analysis is complete and/or when add'l info is rec'd from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614478
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #43 on: January 23, 2014, 08:11:35 AM »

Model Number LEADMVD
Device Problems Dent in material; Electrical shorting
Event Date 03/09/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The deep brain stimulator lead was tested in saline solution prior to implant and was ok. When it was implanted, the hcp determined that there was a short between 2 of the electrodes. Impedances between all other electrode impedances were normal. The lead was explanted and examined. There was a dent in the lead at the top of the depth stop adaptor screw. The screw of the depth stop adapter may have damaged the lead. The longer screw of the new depth stop gave less tactile feedback than the old one and was more difficult to judge how much to tighten it. The hcp opened a second lead and implanted it. The second lead was normal and the case proceeded without further delays. The problem caused a delay of about 15 mins.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658524
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #44 on: January 25, 2014, 02:53:12 PM »

Model Number 7426
Device Problems Kinked; Impedance issue; Positioning Issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4): the device has been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
It was reported lead was explanted due to infection. It was later reported lead was damaged during re-implant. The electrode was damaged while inserting lead through stim loc burr hole cover. The lead was kinked or crimped after insertion and impedances were abnormal. Physician indicated this resulted from sequence of surgical technique and not a faulty electrode. All impedance readings displayed as short circuits. Physician replaced the 1st lead with a new one. The new lead was connected to the current extension and battery. All of the impedances tested within the normal range. The pt's system will be programmed in the next few weeks. There was no pt injury and pt recovered w/o sequela. Add'l info will be provided when it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1850865
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #45 on: January 25, 2014, 02:53:58 PM »

Model Number 37601
Device Problem Battery issue
Event Date 07/22/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient's device was replaced six months after implant due to end of service. Telemetry was performed on (b)(6) 2010 with the printout from the programmer showing the battery at 2. 85v. All impedances were less than 4000 ohms, except one combination used for therapy in the left hemisphere (pair 0,1) was less than 39 ohms. It was felt there was a short circuit issue and parameters were selected (pair 0,2) to give good symptom relief without use of pair 0,1. No further investigation of the lead was planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1814412
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #46 on: January 27, 2014, 02:40:36 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id 3387s-40 lot# v455827, implanted: 2010 (b)(6); product type lead product id 3387s-40 lot# v663231, implanted: 2011 (b)(6); product type lead product id 37092 lot# 249360004, implanted: 2010 (b)(6); product type accessory product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013 (b)(6); product type extension product id 37085-95, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

 
Event Description
The patient experienced a loss of stimulation and therapeutic effect. She had a loss of therapy since the ins was implanted. Impedance testing was done on (b)(6) 2013 and a short circuit was found on the left side of 55ohms. Premature battery depletion occurred, the battery only lasted 8 months. She was to undergo a battery change tomorrow, along with an extension change if the surgeon deemed necessary. It was clarified that the eos/eol message displayed. Eos was reached on (b)(6) 2013. The parameters were: left vim: 0+1-2-3- 4. 0v/150pw/120hz. Right vim: 0+1-2- 3. 3v/130pw/120hz. The second lead, 8-11 was not programmed 4. 45 months. The longevity calculation showed 7. 45 months and eos based on the 100ohms on the left side. Based off the printout of the patient¿s programmed setting the patient was really programmed with the following settings: left: 0+1-2-3- 4v/150pw/120hz. 56 ohms right: 8+9-10- 3. 3v/130pw/120hz. 1111ohms it was unknown when the short started, this was the first time looking at the settings. The (b)(6) 2013, interrogation reports showed: electrodes: 0/2 0/3 2/3 : 57ohms and 2/3 55ohms. The electrodes were tested at 0. 7v: c/11 8/11 9/11: 4500 and 5200 ohms. The left lead showed the short. It was unknown if the patient had a fall. The extension was going to be tested out first. The device printout also showed impedance measurements of 4549ohms with c/11, 9/11 4933ohms and 8/11 5188ohms. The company representative confirmed on (b)(4) 2013 that the ins and both extensions were replaced. Two out of the three short circuits were cleared. See manufacturer report # 3004209178-2013-21797 for the continued short circuit with the new devices.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497599
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #47 on: January 27, 2014, 03:24:46 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0511362v, implanted: (b)(6) 2005, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2013, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v095377, implanted: (b)(6) 2008, product type: lead; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

 
Event Description
It was reported that the healthcare professional explanted and replaced the left extension due to a shocking sensation experienced by the patient. It was noted that there was low impedance of 0<(>&<)>1 18 ohms. Diagnostics included impedance testing and x-rays. It was noted that the short circuit had been resolved and it should alleviate the patient¿s shocking sensation. The issue was not resolved. The patient¿s status was alive with no injury. Additional information received reported that the shocking was resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3514467
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #48 on: January 28, 2014, 09:00:49 AM »

Model Number 37601
Device Problem Low impedance
Event Date 11/22/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).

 
Manufacturer Narrative
Lead model 3389s-40, lot # v333260, implanted: (b)(6) 2009, explanted: na; lead model 3389s-40, lot # v276341, implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; extension model 37085-60, serial # (b)(4), implanted: (b)(6) 2009, explanted: na; programmer model 37642, serial # (b)(4). The initial mdr was filed as mfr report # 3007566237-2010-10148. Additional review indicated the correct manufacturing site was site (b)(4).

 
Event Description
Additional review determined that the previously reported event occurred in (b)(6).

 
Event Description
Additional information received from the hcp reported that the patient had increased amplitude by 0. 1 on each lead. Afterwards, the patient felt that his balance had become worse, he had increased in falls, and he generally did not feel well. It was noted that the patient had also recently reduced his medications. The patient had turned the device off at the request of his hcp. The patient then visited his hcp for an interrogation, which showed that contact pair 8-9 had an impedance of 32 ohms. Contact pair case 2 on had an impedance of 84 ohms. The hcp traced back the patient's records and saw that the short on contact pair 8-9 had existed since (b)(6) 2009. X-rays were taken on (b)(6) 2010 and (b)(6) 2010, but the leads appeared intact and there were no obvious breaks. The patient's voltage was reduced to its previous level, but no further reprogramming was done as the contact pairs with the low impedances were not used in the patient's programming. It was reported that the patient did not require hospitalization, and there was no patient injury.

 
Event Description
Impedance between contacts 8 and 9 was 35 ohms. Using case, 8 or case, 9 and voiding the 8, 9 combination in programming was discussed. It was unk if reprogramming addressed the pt's therapy needs.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937775
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #49 on: January 28, 2014, 09:02:27 AM »

Model Number 37612
Device Problem No Known Device Problem
Event Date 11/01/2010
Event Type  Malfunction 
Event Description
Received info, the pt and physician felt there was a loss of therapeutic stimulation once the battery was at 50-75% on a device implanted in 2009. Pt's neck tremor symptoms are returning, therefore, she now recharges every 2-3 days. The pt has very high settings in terms of amplitude and pulse width. Physician reported there may be a short on electrode 2 and 3 and 2 was essential for stimulation. Impedance readings were from 2582-5544 ohms. Pt is reported as suffering no injury. Add'l info has been requested and if received a f/u report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1950345
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #50 on: February 07, 2014, 12:25:14 AM »

Model Number 37602
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002,product type: lead. Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

 
Event Description
It was reported that there was a possible problem with the implantable neurostimulator (ins). It was noted that the implantable neurostimulator (ins) depletion was being reported as premature. It was noted the last visit in (b)(6) of 2013, both batteries were >2. 90. It was noted that on the date of report the right ins was 2. 95 and the left ins was 2. 63. It was further noted that the settings of the left ins were ¿strange¿ at 0- ,1-,2+,3+; ¿2. 0/90/180. ¿ it was noted that impedance was 1097 with a current of 1. 848. It was noted that a longevity calculation was run with a result of 5-6 years. It was further noted that this only took into account impedance and not configuration. Additionally, it was noted that when an impedance check was done the healthcare professional (hcp) received a message stating that the amplitude delivered might be lower than intended (or something like that) and the hcp should consider reducing the voltage or lowering number of active contacts. It was noted that it made no sense to the hcp. The hcp attempted re-measuring and planned to take a photo but every subsequent measurement went through fine without the error message. It was noted that the hcp did a full impedance check and no problems were found. It was noted that the manufacturer representative conducted another longevity check at the same settings with the result of 5. 46 years to elective replacement indicator (eri) and 5. 71 years to end of service (eos). The manufacturer representative would look at past records for higher settings that may have caused the issue or any impedance data reflecting low impedance or shorts in the past. It was noted that it may have been an intermittent short. It was not known if the patient had any symptoms return in the past. Additional information received reported that the manufacturer representative left a message for the hcp to give a call and discuss the patient settings and whether or not there were any other issues. It was noted that the manufacturer representative had not heard back from the hcp. It was noted that per manufacturer's device registration, the device was explanted (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595748
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #51 on: March 31, 2014, 04:48:56 AM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was a short. It was noted that there were low impedances, less than 50 ohms on 0<(>&<)>1 0<(>&<)>2 and 1<(>&<)>2. Action required as a result of the event was reprogramming. Impedance testing was done. The issue was not resolved and the cause of the issue was unknown. The right lead was reprogrammed to contacts not affected by the short circuit. The implantable neurostimulator (ins) was programmed with 3- <(>&<)> c+. The patient had tremor and modest tremor control with new settings. Patient was alive with no injury and had less than 50% therapy relief at the lead location. The lead impacted by the short was implanted in the right sub thalamic nucleus (stn). The patient had a new thalamic lead implanted in the right ventral intermediate nucleus (vim) to better control his tremor in the left hand on (b)(6) 2014. Surgery for the right vim was scheduled prior to onset of the short circuit in the right stn lead. Additional information received reported there were no additional interventions taken or planned. The patient was not yet programmed and would be programmed in about 3 weeks or so from (b)(6) 2014. Additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3653662
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #52 on: April 10, 2014, 05:28:30 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 3387s-40, lot# va0fbun, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0f26b, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension. (b)(4).

 
Event Description
It was reported that there were low, out of range impedances. The patient was seen on the date of this report for initial programmer. It was unknown when the short impedance had occurred. Post-operative impedance reading was not available. Patient denied any falls or traumas. It was noted that the site looked intact. Impedances were c8 727 ohms, c9 718 ohms, c10 721 ohms, c11 727 ohms, 8/9 813 ohms, 8/10 812 ohms, 8/11 36 ohms, 9/10 35 ohms, 9/11 812 ohms, 10/11 813 ohms. It was later reported that there was a short circuit on all contacts. Surgical intervention was required and surgery was scheduled for (b)(6) 2014. Diagnostic testing/troubleshooting included impedance testing. Patient was alive with no injury. No patient symptoms were reported. It was later reported that the caller was in the revision procedure. Impedances were taken at 1. 5v on (b)(6) 2014 and were in normal range. It was noted that in the operating room prior to closing the patient at the time of implant impedances were c8 903, c9 778, c10 728, c11 683 and 8/11 1162. The healthcare professional had tried to do initial programming the week prior to (b)(6) 2014 and had found a short. On (b)(6) 2014 c/8 and c/11 were at 535 ohms and 8/11 was 38. The patient was not currently programmed on that side. The patient had not fallen or hit their head. The healthcare professional planned to disconnect the right extension from the implantable neurostimulator (ins), reconnect and test impedances. If impedances were still the same they planned to disconnect the lead and extension to test the lead. Additional information received reported that the patient had undergone revision on (b)(6) 2014. Patient had a short on his right side. Impedances were c0 538 ohms, c3 538 ohms and 03 36 ohms. It was determined that the lead was functioning properly and had normal impedances when tested with screening cable. The extension was replaced and the right side was tested after replacing the extension and impedances were within normal range. The patient would be programmed for the first time on the right side in the next few weeks following the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3700820
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #53 on: April 10, 2014, 09:41:43 PM »

Model Number NEU_INS_STIMULATOR
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant products: product id neu_unknown_lead, product type: lead. Product id: neu_unknown_ext, product type: extension. (b)(4).

 
Event Description
It was reported that the healthcare professional had had a case where there was a short at the implantable neurostimulator (ins)/connector. It was noted that pretty much anytime you were able to reproduce some symptoms with palpation/movement then it usually meant a short. It was noted the healthcare professional usually saw them just distal to connector over and unfortunately would have replace the leads in those cases. Surgeon had placed connector higher into portion of the scalp/skullin order to mitigate risk of short on the lead. It was noted that sometimes the screws could be tightened too much and this could cause the issue. Additional information was requested but had not been received as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3697208
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #54 on: April 10, 2014, 09:42:24 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 3387-40, lot# j0527121v, implanted: (b)(6) 2005, product type: lead; product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3387s-40, lot# v006354, implanted: (b)(6) 2006, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead; product id 8840, serial# unknown, product type: programmer, physician. (b)(4).

 
Event Description
It was reported that there were low, out of range impedances. It was noted that the patient fell in (b)(6) 2013. Therapy impedance before fall was 1058 ohms, 58ua and was 123 ohms, 372 ua after the fall. It was noted that other than the short circuit the patient was getting a good therapeutic response. It was noted that the patient may not be a lead replacement candidate. The device was at elective replacement indicator (eri). Manufacturing representative was meeting with the patient and healthcare professional on the date of this report. Additional information received reported the patient was scheduled for surgical evaluation of (b)(6) 2014.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3698928
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #55 on: May 11, 2014, 05:59:50 PM »

Model Number 7428
Event Date 10/24/2013
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4). Analysis results were not available as of the date of this report. A follow up report will be submitted when analysis is complete.
Event Description
It was reported that the battery depletion was normal. It was noted that actions required as a result of the event was surgical intervention. It was noted that the standard surgery procedure to product to replace neurostimulator battery. It was noted that it was unknown if any diagnostic testing or troubleshooting performed. It was noted that the patient status at the time of this report was alive with no injury. Additional information received reported that on the monday prior to explant the therapy impedances were 706 and 944 and current 227 and 171. It was noted that impedance measurements on the left side showed that there was a shortcut between el1 and el3. It was noted that chronic stimulation they use on the left side 0-positive and 1-negative. It was noted that this resulted in chronic stimulation having effectively 2 negative electrodes. It was noted that el1 was intended and el3 was short with el1 which may explain why the battery was emptying relatively fast. It was noted that chronic stimulation they used 6. 1 volts, 130 hz, and 210 micros on both sides. It was noted that the battery current drained measured in the therapy measurement mode was for both sides about 200 microa, which was high and this was part of the explanation why the battery was empty in a relatively short period. It was noted that since the patient was receiving good effect when the stimulator worked they decided to implant a new battery despite the fact that there was a short circuit between the electrode contacts on the left side. It was noted that the next step was going to be to find out where the problem was and then try to do it by systematic elaborate non-invasive impedance measurements potentially followed by invasive trouble shooting if evidence of the non-invasive trouble shooting suggested that is what was needed. It was noted that the ¿lifted bond wire issue¿ was not at play in this situation.
Manufacturer Narrative
Final analysis of the stimulator revealed no significant anomaly. The battery was not in the new condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736853
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #56 on: May 11, 2014, 06:01:35 PM »

Model Number 7428
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
(b)(4).
Event Description
It was reported the battery had premature depletion. The battery was planned to be explanted (b)(6), 2014. It was unknown if there were any patient symptoms or complications associated with the event. Additional information reported the impedance values were within range. The voltage measured was 2. 6 volts and the capacity used was 40-85%. It was also noted with the patient¿s settings the device should not be depleted. It was confirmed that the patient had never experienced any kind of ¿shortcut¿ sensation during the study. Additional information reported that it was too early to say if the device was depleting faster than expected. The battery was about half way through the battery and it was possible it would reach its estimated longevity of 8 months. Additional information noted that the battery was now depleted and had a longevity of four months which was less than expected. Additional information noted that the patient was not doing well without their device and was to be explanted in a couple of days. Additional information reported that impedance measurements from the left side showed there was a shortcut between 1 and 3. In chronic stimulation they used left side 0 positive and 1 negative. It was noted this could explain why the battery emptied relatively fast. The battery current drain measured in therapy measurement mode was 200 microamps for both sides. It was noted this was high and part of the explanation on why the battery was emptied in a relatively short period. Due to the patient having had good effect when the stimulator worked, they planned to replace the battery and to investigate the short circuit at a later date. It was noted that due to the condition of the patient there was no time to perform systematic impedance measurements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3748635
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #57 on: May 11, 2014, 08:46:27 PM »

Model Number 37602
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40 lot# v700663, implanted: 2011 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v475781, implanted: 2010 (b)(6); product type lead product id 37602, serial# (b)(4), implanted: 2013 (b)(6); product type implantable neurostimulator product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).
Event Description
It was reported that the patient¿s primary cell devices had depleted and the healthcare professional wanted to switch the patient out to two rechargeable devices. There was an apparent short on combination 1 and 2 which had shown 7 ohms. Therapy impedance was 474 ohms. It was noted that combination 1, 2 was not used in the programming. It was further noted that the patient got almost 100% relief from her dystonia symptoms. Additional information received reported the implantable neurostimulator (ins) with the short had depleted somewhat faster than the other side. It was noted that impedance difference between left and right inss had accounted for that difference. Both inss were explanted and replaced with rechargeable devices on each side. The patient was doing well and receiving therapy. Reference manufacturers report number: 3004209178-2014-05889.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736583
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #58 on: June 07, 2014, 10:05:05 AM »

Model Number 37602
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported there was an end of service (eos) message. It was noted the implantable neurostimulator (ins) was at eos and defective. It was noted the settings or impedances were not known at the time of report. It was stated they did not know when the eos appeared. It was further reported the patient had a short in their system due to the use of the patient¿s glasses. It was noted the patient¿s system was implanted about 10 years prior to report and they had always worn a pair of glasses that had pressed right up against the lead/extension connection. It was noted they could see the damaged area through the skin. It was noted the system was checked and a short was evident. It was stated the patient would follow up with their surgeon and prepare for a revision procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800708
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59442


« Reply #59 on: June 07, 2014, 10:06:14 AM »

Model Number 37603
Event Type Injury Patient Outcome Required Intervention
Event Description
It was reported there was battery depletion. It was stated there was low impedances of 49 ohms on electrodes 2 and 3. It was stated a replacement surgery was required as a result. It was noted the issue was not resolved. It was noted they may have tried to program around the short. It was noted the patient¿s device was at end of service (eos). It was stated the patient¿s status at the time of report was alive with no injury. It was noted no patient symptoms occurred. It was noted the device was at eos and impedances showed a short circuit on contacts that were utilized on 3 and 2. It was noted the device was replaced. It was further reported the date the eos was seen was on (b)(6) 2014. It was noted the patient did not know when the message began. It was stated the patient had used contact 3 and 2 with 5. 2v for therapy control. It was noted the patient received therapy after the generator change.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3821427
Logged
Pages: 1 [2] 3 4  All   Go Up
Print
Jump to: