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Author Topic: Deep brain stimulator - Stimloc  (Read 10190 times)
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dennis100
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« on: January 19, 2014, 10:34:04 PM »

Device Problem Deployment issue
Event Date 11/12/2009
Event Type  Injury  
Manufacturer Narrative
 
Event Description
The stimloc was attached to the patient's skull in the prescribed fashion with the locking plate and cap both clicked into place to hold the lead in the position. The surgical wound was closed/covered and the patient was repositioned and re-draped on the table. The stimloc cap was noted to have popped off the stimloc base. The surgeon was concerned that the lead may have withdrawn slightly from the target position within the brain. The hcp was unable to ascertain if the lead had migrated using x-rays taken prior to attachment of the lead to the extensions. A post operative computed axial tomography was planned. There was no patient injury associated with the event. 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=1560697
« Last Edit: November 08, 2014, 08:13:10 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 20, 2014, 04:57:10 AM »

Model Number 7428
Device Problems Migration of device or device component; Impedance issue
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient suddenly was not getting efficacy. Impedance measurements had been "weird" since the device was implanted. A ct scan was done and found that the lead had pulled all the way up to the skull level at the cap and stimloc. A revision was done; the lead and stimloc visually looked fine. The stimloc mechanism was still closed, but did not appear to be functioning. There didn't seem to be excessive pulling on the lead. The lead and stimloc were replaced. 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=1575814
« Last Edit: November 08, 2014, 08:11:59 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 25, 2014, 02:45:00 PM »

Model Number STIMLOC
Device Problem No Information
Event Date 08/30/2010
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that the blades of the driver had twisted upon screwing stimloc into the skull. The other drive was used in this bilateral case. Pt recovered without sequela. Additional information has been requested and will be made as follow up as it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1852077
« Last Edit: November 08, 2014, 08:11:29 AM by dennis100 » Logged
dennis100
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« Reply #3 on: January 25, 2014, 02:45:46 PM »

Model Number USED WITH 3387 & 3389
Event Date 07/16/2010
Event Type  Malfunction  
Event Description
The gate was engaged, but the electrode pulled back as the physician coiled extraneous wire underneath the scalp prior to closing, suggesting that the gate and cap were incompetent. In patient 1's case, this was not recognized until the postoperative mri the day after the first surgery. This necessitated another surgery, but no long-lasting ill effects. This happened again with patient 2 but fluoroscopy was used prior to closing so the situation was corrected. In both cases, the gate and cap were placed properly and were intact.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1835952
« Last Edit: November 08, 2014, 08:11:12 AM by dennis100 » Logged
dennis100
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« Reply #4 on: January 25, 2014, 02:46:53 PM »

Model Number LEADMVD
Device Problem Device operational issue
Event Date 07/23/2010
Event Type  Malfunction  
Event Description
It was reported that the support clip of the pt's stimloc system failed to adequately secure the lead. The physician used a silk tie to further secure the lead. There was no pt injury. The pt recovered without sequela. No further details were provided at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1816225
« Last Edit: November 08, 2014, 08:10:56 AM by dennis100 » Logged
dennis100
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« Reply #5 on: January 25, 2014, 02:47:36 PM »

Model Number STIMLOC
Device Problem Misconnection
Event Date 05/15/2010
Event Type  Malfunction  
Event Description
It was reported that it was impossible to insert the support clip of the stimloc to the base. The device was not "fully implanted" as the issue occurred intraoperatively. The device was replaced and the patient's outcome was "good".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1775786
« Last Edit: November 08, 2014, 08:10:40 AM by dennis100 » Logged
dennis100
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« Reply #6 on: January 25, 2014, 02:48:28 PM »

Model Number STIMLOC
Device Problem Break
Event Date 05/25/2010
Event Type  Malfunction  
Event Description
While implanted the stimloc bur hole cover, one of the screws broke. The distal part of the screw remained implanted in the patient's skull. The hcp used another screw and successfully implanted the stimloc. There was no patient injury associated with the event. The patient was ok afterward.

 
Manufacturer Narrative
(b)(4). (b)(4). The screw was returned to the manufacturer for analysis which is not complete as of the date of this report. A follow-up will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1735735
« Last Edit: November 08, 2014, 08:10:20 AM by dennis100 » Logged
dennis100
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« Reply #7 on: October 13, 2014, 03:44:13 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 08/13/2014
Event Type Injury
Manufacturer Narrative
Product id: 924256, lot# 082224713a, implanted: (b)(6) 2014, product type: accessory. (b)(4).

Event Description
It was reported the stimloc seemed to be closed properly and hold the lead, but the stimloc was actually defective and the lead pulled out. The plate that was supposed to hold the lead was defective. The patient¿s healthcare professional (hcp) noticed in a ct scan after lead implantation that the lead was too high from the target and they had to go back to the operating room to fix it. In order to make sure the lead was in the target the hcp had to use x-ray because they could not use the guide wire any more. To fixate the lead the hcp used a surgical plate because they did not want to change the existing stimloc. After the second stage, the lead seemed to be fine. There were no patient symptoms or complications associated with this event and the patient status at the time of this report was alive with no injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4054596
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dennis100
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« Reply #8 on: November 08, 2014, 08:10:01 AM »

Model Number 3387
Event Date 09/10/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 3389, serial# unknown, product type: lead; product id 3389, serial# unknown, product type: lead; product id 924256, lot# 082232413a, product type: accessory; product id 924256, lot# 082234013a, product type: accessory. (b)(4).

Event Description
It was reported during a procedure to place the deep brain stimulator (dbs) system when the doctor placed the stimloc, the window of the stimloc would not close properly so that the lead was not being secured in the stimloc and the lead seemed to move around still. The window of the stimloc itself didn¿t seem to lock properly in place. They could tell the lead moved when they worked with placing the cap on the stimloc. The doctor was concerned about replacing the stimloc as it would likely cause the lead to move further. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4135615
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dennis100
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« Reply #9 on: February 07, 2015, 11:26:49 AM »

Model Number NEU_UNKNOWN_LEAD
Event Date 12/17/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 924256, lot# 082200814a, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: accessory. (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 at the time of implant the ¿slide on the stimloc would not click into place. ¿ a replacement stimloc was used and ¿worked as it should¿ at the time of implant. It was noted the issue was resolved and ¿there were no other issues. ¿ there were ¿no¿ patient symptoms or complications associated with the event and the patient was alive with no injury at the time of report. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4396394
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dennis100
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« Reply #10 on: March 07, 2015, 03:58:17 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that a post-operative ct scan showed that the left lead moved superior by a few centimeters. The stimlock was reported to be the issue; not the lead. The original lead that was implanted was removed and a new lead was implanted in the left hemisphere at the original implant location. Once the lead was replaced the implantable neurostimulator (ins) was implanted in the left chest. The patient was alive with no injury.

Manufacturer Narrative
Product id 3389s-40, lot# va0rr28, implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4); product type extension product id 3389s-40, lot# va0rr28; product type lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4546652
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dennis100
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« Reply #11 on: June 08, 2015, 06:13:34 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3387s-40, lot# v951526, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va00v17, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported that the patient never had therapeutic effect. Imaging was done of the system and it was found that one side of the system had the lead superficial to where it should be located, approximately 0. 5 centimeters, and the other side was about 1 centimeter superficial to where it should be located. The leads were removed on (b)(6) 2015. When the leads were removed it was found that, even though the stimlock support was closed, they were still able to pull the leads out and thus were concerned there was an issue with the stimlock system. The patient was going to have a revision on (b)(6) 2015 to pull the stimlocks. The patient outcome was not yet available since a later surgery was scheduled, so additional information will be requested at the appropriate time. If additional information is received a supplemental report will be sent. Refer to manufacturing report #3004209178-2015-08784 as the patient had two inss and both leads had placement issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760127
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dennis100
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« Reply #12 on: June 08, 2015, 06:14:21 AM »

Model Number 3389S
Event Date 04/26/2015
Event Type Injury
Manufacturer Narrative
(b)(4). Device evaluation: analysis of the lead found the lead body was ¿stretched. ¿ analysis of the stimloc found no anomaly.

Event Description
It was reported that after being implanted with a deep brain stimulation (dbs) lead the day prior to report, the patient had ¿seizures during hospitalization¿ on the day of report. Ct imaging was performed to identify the issue and found that ¿lead displacement was the root cause. ¿ two days after initial report, the patient¿s lead was revised and the patient¿s physician reported the ¿stimloc was loose¿ and that this had ¿resulted in the lead displacement. ¿ both the stimloc and lead were replaced at that time. There were ¿no complaints¿ since the replacement. The patient was discharged and back home as of nine days after initial report and was to ¿start implantable neurostimulator (ins) in (b)(6) 2015. ¿ additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant products: product id neu_leadcap_acc, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type accessory; product id m924256a003, serial # (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type accessory. (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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4769128
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dennis100
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« Reply #13 on: June 08, 2015, 06:15:03 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_stimloc_acc, serial# unknown, product type: accessory. (b)(4).

Event Description
It was reported the parksinons¿ disease patient¿s stimloc device ¿caused a cerebral spinal fluid (csf) leak. ¿ the operating physician indicated ¿the location was between the chassis and skull and he used a biological protein gel to fill the gap during the surgery. ¿ the patient was noted to be ¿good after the surgery¿ with the stimloc remaining implanted. It was reported the stimloc has been had been inspected prior to use and there were no abnormalities found; however there was a package abnormality noted before opening. No further information was available regarding the event; additional information has been requested. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4795368
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« Reply #14 on: August 08, 2015, 08:50:42 AM »

Model Number 3389S-40
Event Date 06/14/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
During operation on (b)(6), the lead could not be completely fixated using a stim lock, which is an accessory of the device. Lead fixation could not be adequately performed; so a spare device was used to deal with the issue. There was a stim lock defect. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882995
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« Reply #15 on: August 08, 2015, 08:51:21 AM »

Model Number 37603
Event Date 06/29/2015
Event Type Injury
Event Description
It was reported there was lead migration. Surgical intervention was required as a result of the event and it was replaced with a new lead and new ¿stim¿ cap. The issue was resolved. The cause of the issue was determined ¿ the stimloc ¿pac-man¿ slipped and didn¿t lock in place which caused the lead to move. The patient didn¿t have tremor control and they had tremor in their right hand. Their status at the time of report was alive with no injury.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0urxw, explanted: (b)(6) 2015, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4919648
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dennis100
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« Reply #16 on: September 07, 2015, 06:10:10 AM »

Model Number 37603
Event Date 07/29/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# v902308, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6)2012, product type: extension. Product id: 3387s-40, lot# v688050, implanted: (b)(6) 2012, product type: lead. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

Event Description
A healthcare professional reported that on (b)(6) 2015 there was an infection at the stimlock and on (b)(6) 2015 there was an explant. It was unknown what had led to the event. A culture was taken. The issue was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5026115
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dennis100
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« Reply #17 on: September 07, 2015, 06:10:52 AM »

Model Number 37601
Event Type Injury
Event Description
A manufacturing representative reported the patient had the lead on their right side removed due to an infection. The lead had started to erode through the skin around the stimloc. Relevant patient history included parkinson¿s disease and movement disorders. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976779
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