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Author Topic: Deep brain stimulator - Protrude/Extrude  (Read 11885 times)
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dennis100
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« on: February 06, 2014, 10:52:36 PM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0ak26, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va08uvg, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s implantable neurostimulator (ins) was protruding through the skin and the pocket needed to be revised. The reporter stated that had not yet been any diagnostic testing or troubleshooting performed, but there would be in the future. It was noted that the ins was still implanted and remained in service. The patient status was noted to be alive without injury. Additional information received reported that the patient's pocket was revised on (b)(6) 2014. It was noted that the impedances were obtained before and after the surgery and all of the values were "normal. " it was further noted that the cause of the protrusion was not determined. It was noted that the pocket appeared "normal" and there was no evidence that anything was wrong with the exception of the patient's complaints. The patient outcome was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3602103
« Last Edit: August 08, 2015, 07:55:54 AM by dennis100 » Logged
dennis100
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« Reply #1 on: April 10, 2014, 05:20:32 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was uncomfortable with the high profile stimlocs protruding on his head. Due to this and the ¿older button,¿ the doctor removed both for a more comfortable feel for the patient. The leads were left in place. At the time of the report the patient was alive with no injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679883
« Last Edit: January 10, 2015, 04:12:42 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 10, 2015, 04:13:20 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that on (b)(6) 2013, the patient ¿presented to his local hospital with an infected chest incision¿ and device pocket. The patient was transferred to another hospital where he received ¿intravenous antibiotics and treatment¿ and had his ¿chest implantable neurostimulator (ins) removed. ¿ then, during a follow-up visit on (b)(6) 2014, it was found the patient¿s extension was ¿protruding behind his left ear. ¿ additionally, it was noted the right burr hole was ¿reddened and weeping¿ at that time. The patient reported that had been ¿going on a few weeks¿ prior to the follow-up visit. The patient was administered additional antibiotics at that time and was admitted to the hospital as a result. The following day, the patient¿s system hardware was revised and the patient was again administered intravenous antibiotics and their ¿home course was completed. ¿ however, it was reported that on (b)(6) 2014, the patient¿s incisions were notably ¿still not healing¿ and their remaining system hardware was removed as a result. There was notably ¿no alleged product issue¿ with the explanted devices. The patient was alive with no injury at the time of report. The patient¿s infection had reportedly ¿resolved¿ at the time of report. The patient was implanted with a full, new system four days after initial report and was receiving effective therapy as of 22 days after initial report. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_ext, lot# serial# unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: extension. Product id: neu_unknown_ext, lot# serial# unknown, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: extension. Product id: 3389-40, lot# 0207343315, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead. Product id: 3389-40, lot# 0207314831, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330618
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dennis100
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« Reply #3 on: January 10, 2015, 08:23:43 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0k331, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
It was reported that on monday prior to the date of this report the patient had hit one of his generators with his car door and it had become exposed. A picture was taken and you could see the generator protruding through the skin. The generator was explanted on monday prior to the date of this report. No diagnostic testing or troubleshooting was done. The issue was not resolved. The patient was alive with no injury. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted. Reference manufacturer¿s report number: 3004209178-2014-22812.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4307687
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dennis100
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« Reply #4 on: March 07, 2015, 03:49:27 AM »

Model Number 37601
Event Date 10/15/2014
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0l1c8, implanted: 2014 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0l1c8, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension. (b)(4).

Event Description
It was reported the patient presented to the emergency room after sustaining a fall outside their home which resulted in wound dehiscence and exposed stimulator and extensions. The stimulator and extensions were immediately removed and replaced. The etiology was the stimulator pocket and was noted as not related to the device, therapy, or implant procedure. The event resulted in in-patient hospitalization and required surgical intervention. The event was considered resolved without sequelae.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4508511
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dennis100
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« Reply #5 on: March 07, 2015, 03:50:10 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient had their deep brain stimulator installed in 2012 and after discovering an exposed wire had the present unit installed on (b)(6) 2013. The patient¿s neck had been bothering him for a couple of months so the healthcare professional had checked it and discovered the wire was exposed. The exposed wire was discovered 8 months after implant. A replacement was done on (b)(6) 2013. They had to rewire everything and the healthcare professional was playing it safe because they were afraid there might be an infection. No infection was reported that was just the reasoning for doing everything except the leads. The patient¿s last visit to the healthcare professional was on (b)(6) 2013 and they had not followed up with the patient since the event. The patient had not had concerns with their device or therapy.

Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4526333
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dennis100
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« Reply #6 on: March 07, 2015, 03:50:54 AM »

Model Number 37602
Event Date 01/27/2015
Event Type Injury
Event Description
It was reported that it appeared that a lead wire had worked itself to the surface of the patient¿s scalp. The reporter noticed it the morning of the report and there was a spot on the patient¿s head that had not healed. On the day of the report the scab peeled away and the lead wire could be seen. Follow-up information received from the healthcare provider (hcp) reported that there was an exposed wire at the top. The cause of the event was determined and not device related. The lead, extension, and implantable neurostimulator (ins) were all explanted. The patient recovered without permanent impairment and would be re-evaluated to see if she should be re-implanted.

Manufacturer Narrative
Concomitant product: product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type extension; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4520919
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dennis100
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« Reply #7 on: April 19, 2015, 01:15:06 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Product id neu_unknown_lead, lot# unknown; product type lead. (b)(4).

Event Description
It was reported that the patient was admitted and their right deep brain stimulation (dbs) system was explanted. The implantable neurostimulator (ins), lead, and extension were removed. The reason for removal of the system was infection of the lead. The lead had also eroded and protruded through the patient¿s skin. It was also noted that the ins looked like it was ¿at the start of infection. ¿ it was unknown if perioperative antibiotics were administered or when the infection began. The type of organism was also unknown, and it was unknown if the infection resolved. Follow up had been performed and additional information could not be obtained at the time of this report. Should any additional information be received, a supplemental report will be filed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4614023
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« Reply #8 on: April 19, 2015, 01:15:48 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id neu_unknown_ext, serial # unknown, implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v281324, implanted: (b)(6) 2010, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v255260, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported the lead/extension connection behind the patient¿s ear was eroding through the skin. The patient¿s entire system was being removed. Once healed, the patient would have another system implanted. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4645081
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dennis100
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« Reply #9 on: April 19, 2015, 01:16:39 AM »

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

Event Description
It was reported that there was erosion of the system through the patient¿s skin. An infection was also noted. The surgeon decided to remove the left side system once "it had been seen" during the removal of the right system [see note below]. The reporter was unsure if the patient was going to be implanted with a replacement system. Refer to manufacturer¿s report number 3004209178-2015-05329 for information pertaining to the patient¿s other system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4628672
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dennis100
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« Reply #10 on: April 19, 2015, 01:17:14 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that there was erosion of the system through the patient¿s skin, particularly the right lead and extension. An infection was also noted. The entire right side system was explanted as a result. The reporter was unsure if the patient was going to be implanted with a replacement system.

Manufacturer Narrative
Product id 3387-40, lot# b0477657k, implanted: 2007 (b)(6), explanted: 2015 (b)(6); product type lead product id neu_unknown_ext; product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4628596
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dennis100
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« Reply #11 on: April 19, 2015, 01:17:58 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the lead wire was rigid and it caused the patient¿s neck to be sore and stiff. There was pain in the neck at the extension location. It had been progressively getting worse since (b)(6) 2014 when the patient had gotten the implant. The patient¿s extensions were too tight. There was a lead/extension issue, it was too tight from the lead connection down to the clavicle. No action was required as a result of the event. In (b)(6) 2015 the healthcare professional had done a revision, they had gone in to pull the lead wire up and they had pulled some of the extension wires up in the neck to see if that would loosen the wires to give the patient more slack or loosen the wires, but that had not worked and the patient had a bundle of lead wire protruding under the skin above the clavicle. The patient had a buckled wire around the clavicle. The patient was very thin so he scared easily. The patient had stated that the design for a lead that would not cause scar tissue should be a ¿requirement. ¿ the healthcare professional had told the patient that because he was very thin and had little subcutaneous fat the wires had not ¿skude¿ under the skin as well. The healthcare professional also told the patient that the manufacturer needed to coat the extension with nano technology in order to fix the problem. The current extension wire formed scarring which lead to pulling and pain in the neck. Patients with a lot of fat had not experienced the issue but others do. This was becoming a common problem. The cause of the event was determine and was device related. The healthcare professional thought the coating applied to the wire, all of the wires got scarring then tended to cause pulling unless the patient had a lot of fat which acted as a lubricant. The patient had not recovered, symptoms/issue was ongoing. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0hyjm, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4613200
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« Reply #12 on: April 19, 2015, 01:18:50 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 64002, lot# n386022, implanted: 2013 (b)(6); product type adapter product id 37642, serial# (b)(4); product type programmer, patient product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v553427, implanted: 2010 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v550216, implanted: 2010 (b)(6); product type lead. (b)(4).

Event Description
It was reported that there was an infection. The patient had had the device for a year and it was removed due to bacteria on her skin which had caused an infection. The healthcare professional had done testing for (b)(6) and 3 other cultures which had all come back negative. Infectious disease was running tests as well. For the past 6-7 months prior to the date of this report it had been getting sore and on the right side there was blood gathering but no drainage. The patient felt like they were being cut from the inside. The battery was still functioning and stimulation was at 4. 0v. Eventually on (b)(6) 2015 the implantable neurostimulator (ins) had broken through the skin and the patient was seeing a clear yellow fluid with no pus or odor. The patient had called the healthcare professional the following day. On friday (b)(6) 2015 there was more drainage, the patient had pressed on it and took an alcohol pad and saw pus and some green stuff as she cleaned the dead skin off and then she saw the battery tip. The patient was taken to the emergency room via ambulance where they drew some blood and took out the ins on (b)(6) 2015. The patient was on antibiotics for 4-7 days and medication for dystonia. The patient doubted that it was an infection and prior to the device coming out it had been shifting and had gone in to her arm pit. The patient had not had any fevers, had not felt sick or had night sweats and felt the battery fluid was leaking out of the ins. The patient had had lab work done in (b)(6) prior to the date of this report and everything was fine. The patient stated that ¿all of a sudden this clear yellow fluid was coming from the battery started leaking out and it ate her skin. ¿ the patient was getting electrical surges in her head which would happen a couple of times a day. The patient was scheduled to see their healthcare professional on (b)(6) 2015. The healthcare professional stated the bacteria on the skin had caused all the issues. The patient stated that she had had the battery for 4 years and worked in a hospital and never had this happened before. The patient could feel the battery shifting and one day there was sweat on shirt and here the battery had opened a clear yellow odorless. The patient believed the battery was faulty. The past month prior to the date of this report had been terrible, the patient could not work, drive, or watch tv. The patient stated that the ins ate through her skin and was all taken out. Components involved were ins, extension and pocket adaptor. The ins protruded the skin. No troubleshooting was done. The action taken was explant. It was device related, they suspected there was increased bulk by adding the pocket adaptor which pushed the ins into the skin leading to breakdown. Patient outcome was unknown. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577485
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dennis100
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« Reply #13 on: April 19, 2015, 01:19:30 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# va0jhdm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0p59t, implanted: 2015 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension (b)(4).

Event Description
It was reported, the patient had a shocking or jolting sensation. The patient¿s right extension was poking through the skin and was shocking the patient. A right side extension revision was done on 2015 (b)(6). The patient left the hospital being programmed to 1v and had no adverse events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587396
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« Reply #14 on: April 19, 2015, 01:20:15 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that six months prior to this report the patient had a revision surgery to correct a ¿bowstring cord¿ problem in their neck. The implantable neurostimulator (ins) was initially implanted in the patient¿s chest and the revision was done to relocate the ins to the abdomen and add two extensions. For the past two months the problem had reoccurred and appeared to be worse than before. The patient had a loss of therapeutic effect, their therapy was in decline, and they were not getting any therapy benefit. At the time of this report the ins was on and the patient had not had any falls or trauma. The wires in the patient¿s neck were pulling and tugging again and they had become very tight. The patient stated it felt like the wire shifted and was pulling in the same area of the neck again. The patient had pain in their shoulder, chest, and neck especially after waking in the morning. The patient¿s pain and discomfort was moderate, but it was increasing on the side where the wire was running to the ins. The patient had been stretching their neck and that seemed to help take the strain off of the cord a little, but it was very painful to do it. The patient stated they had no idea if they were damaging the cord, units, or implants while stretching their neck. The patient had noticed indentations in their head and a bulge where one of the caps and wires was coming loose from the skull. The patient noticed they had swelling in their chest where the old ins and there was a bunching of wire in their abdomen by the ins. The patient had lost 10-15 pounds and they stated that may account for the noticeable signs in their head and stomach. Overall the ins was doing its job and functioned well and the patient felt the benefits outweighed the negatives. The patient¿s healthcare professional (hcp) did not see anything concerning and they thought the scarring around the extension was contributing to the discomfort. The patient¿s main concern was that if the wire continued to stretch, would it cause problems with the vein or artery that crossed their neck or would it pull on the leads in their brain. Almost two weeks later, the patient reported that their ins was not working correctly and there appeared to be a partial or total failure. The patient programmer was not picking up anything and the recharger was sporadic at picking up a signal. The patient was not sure if this was related to the extreme pulling in their neck or the bunching of wires in their abdomen near the ins. The patient was not feeling as much of the benefits and they were concerned that a wire might be loose and the programmer was inoperable. The patient was not able to turn the ins off since the programmer was not recognizing or reading the ins and it did not show any signs of an ins being present. The recharger had been able to connect to the ins just fine at times and had shown the ins was charging and functioning. The patient knew the ins was on as they were feeling some benefit. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, the event will be updated.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0gh58, implanted: (b)(6) 2014, product type: lead. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014,product type: extension. Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4596445
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« Reply #15 on: April 19, 2015, 01:21:04 AM »

Model Number 37602
Event Date 04/18/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 338902836, lot# b9993681k, implanted: (b)(6) 2000, product type: lead. Product id: 338902836, lot# b9992982k, implanted: (b)(6) 2000, product type: lead. (b)(4).

Event Description
It was reported the left stimulator was visible and the wound was open. After the surgery a crust formed on the wound and when it fell off there was an open wound in which the stimulator was visible. The patient did not contact their physician at the time. The patient was hospitalized and the stimulator was explanted and not replaced. The event was related to the procedure and the outcome was ongoing. If additional information is received on outcome, a follow-up report will be sent. Refer to manufacturer report # 3004209178-2015-04537 it was unknown which stimulator was explanted and replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4591605
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« Reply #16 on: May 09, 2015, 12:11:15 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant: product id 37085-60, serial# (b)(4), implanted: 2012-(b)(6), product type extension. Product id 37085-60, serial# (b)(4), implanted: 2012-(b)(6), product type extension. Product id 3387s-40, lot# v875201, implanted: 2012-(b)(6), product type lead. Product id 3387s-40, lot# v857736, implanted: 2012-(b)(6), product type lead. (b)(4).

Event Description
It was reported that the implantable neurostimulator (ins) started bulging out and the patient had to have a revision in 2013. There was no problem with the ins, only a problem with its placement. The ins started bulging out again and another revision was performed in (b)(6) 2013. The patient outcome was not reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4689091
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« Reply #17 on: May 09, 2015, 12:11:56 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0juzg, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0juzg, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va0juzg, implanted: (b)(6) 2014, product type: lead; product id 3389s-40, lot# va0juzg, implanted: (b)(6) 2014, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported the patient had dehiscence along both cranial incisions, their leads were exposed and there were signs of wound infection. The patient had cranial incision breakdown and the primary location of the infection was the right and left cranial incision. Perioperative antibiotics had been administered and there had been no mention of meningitis. The surgeon decided to explant the patient¿s entire system. The patient had no additional complications. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4693900
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« Reply #18 on: June 08, 2015, 05:47:18 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0p7r6, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0nh9u, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the lead/extension connection had eroded through the skin. An explant was required as a result of the event and the products would be replaced in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755206
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« Reply #19 on: June 08, 2015, 05:48:03 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3 387s-40, lot# va09wvk, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 3387s-40, lot# va09wvk, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
It was reported that there was an extension that eroded through the skin. The manufacturer representative (rep) stated the surgeon was planning on removing the whole system the day of the report. The tissue was going to be cultured even though the area didn't look infected and a new system would be implanted in three months if everything went as planned. It was later reported that the patient was doing fine.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4766252
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« Reply #20 on: June 08, 2015, 05:48:44 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported that a short time after implant, while the patient was showering, the implantable neurostimulator (ins) fell out of the pocket right into her hand with blood all over. She was rushed into a second surgery to anchor down the ins and it was sutured down to the chest wall. The patient outcome was not reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v011075, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755339
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« Reply #21 on: August 08, 2015, 07:54:58 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension. Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead. Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead. Product id: 7426, serial# (b)(4), product type: implantable neurostimulator. Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead. (b)(4).

Event Description
It was reported that around 2011 the patient had bumped his head where the deep brain stimulator was located. The patient had a scuff there that had seemed to heal but a short time later had become red and sore. The patient saw a physician assistant for the redness and soreness and they were going to keep an eye on it to see if it healed. The wound went back and forth from healing to not healing so the physician assistant sent the patient to doctor. The doctor had seemed concerned and they opened up the wound in an attempt to heal the infection and then re-stitched it closed and the patient was put on a very strong antibiotic in hopes of the wound healing. The wound did not heal as they had hoped and the wires were exposed the next time the patient had seen the doctor and the infection was not healed. The doctor then made the decision to remove the left device due to the infection. The skin where the implant was located was very thin with poor blood supply and he thought that contributed to the fact that they could not get the infection and wound to heal properly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4928804
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« Reply #22 on: August 08, 2015, 07:56:48 AM »

Model Number 37612
Event Date 06/26/2015
Event Type Injury
Event Description
It was reported the patient experienced dehiscence with their implantable neurostimulator (ins). It was further reported there was an infection of the wound. A revision procedure was performed due to the dehiscence. It was noted the patient¿s sister ¿thought the dehiscence was due to the stimulator that warmed the tissue and burned it. ¿ the patient¿s ins was ¿placed under muscle in a thin patient¿ and otherwise ¿charged with good performance. ¿ additional information has been requested regarding the patient¿s outcome; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4922684
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« Reply #23 on: August 08, 2015, 07:57:30 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2015 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0j3u3, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0e81e, implanted: 2014 (b)(6); product type lead. (b)(4).

Event Description
It was reported that the patient¿s extensions eroded through her skin at the lead location. Impedance testing was performed and the extensions were replaced. The issue was resolved, but the cause was not determined. The patient was alive with no injury at the time of the report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4899150
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« Reply #24 on: August 08, 2015, 07:58:32 AM »

Model Number 37612
Event Date 06/09/2015
Event Type Injury
Manufacturer Narrative
Final analysis of one of the leads with lot v014246 revealed the outer insulation was breached 33 centimeters from the distal end. Analysis of the other lead with lot v014246 revealed no significant anomalies. The lead body was cut through and segmented. Final analysis of extension (b)(4) revealed no significant anomalies.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v014246, implanted:(b)(6) 2007, product type: lead. Product id: 64002, lot# n318565, implanted: (b)(6) 2012, product type: adapter. Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted:(b)(6) 2007, explanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, explanted:(b)(6) 2015, product type: extension. Product id: neu_burrholecap, product type: accessory. Product id: neu_burrholering, product type: accessory. Product id: 3550-29, product type: accessory. Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead. Product id: neu_stimloc_acc, 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 there was protrusion of the right extension on the head near the ear due to lead explant. The right lead was explanted and detached from the extension left at the time of lead explant. Upon inspection in the emergency room inflammation and infection was noted for the extension. The type of infection was unknown. The event required a hospital emergency room visit which resulted in admission. A cat scan was performed and swelling over the extensions was noted. The entire system was explanted as an intervention. The event was recovered with sequelae.

Manufacturer Narrative
Previously the event was noted as a malfunction. Supplemental has been sent to update to serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889156
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« Reply #25 on: August 08, 2015, 08:00:07 AM »

Model Number 37601
Event Date 02/23/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 64002, lot# 0208153843, product type: adapter. Product id: neu_unknown_lead, lot# unknown, explanted: (b)(6) 2015, product type: lead. Product id: neu_unknown_ext, serial# unknown, explanted: (b)(6) 2015, product type: extension. (b)(4).

Event Description
It was reported that the patient had a dermatology surgery on (b)(6) 2015 and since that surgery the lead wire had gone out of scar. During a follow up visit on (b)(6) 2015 the healthcare professional had observed that the lead wire was visible, there was exteriorization of the wire. Patient experienced no symptoms, no inflammation. Examination was done on (b)(6) 2015 and the neurological exam was normal; patient required in patient hospitalization, emergency room visit, urgent care visit and an unscheduled clinic visit. The entire system was explanted and was not replaced. The issue was resolved, patient was alive with no injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4952249
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« Reply #26 on: September 07, 2015, 06:17:51 AM »

Model Number 37601
Event Type Injury
Event Description
The health care provider (hcp) reported via the company representative that the extension/lead connection was eroding through the skin. A surgical revision was performed on (b)(6), 2015 during which they replaced boots on the connectors and irrigated. It was noted that ¿everything [was] normal following surgery¿ as of the after the revision. The doctors were going to monitor the patient and if the issue developed again they would possibly remove the system. Indications for use: parkinsons dual <(>&<)> movement disorders.

Manufacturer Narrative
Concomitant medical devices: product id: 37642, serial# (b)(4), implanted: (b)(6) 2014, product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jqf9, implanted: (b)(6) 2014, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0jqyg, implanted: (b)(6) 2014, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4965148
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« Reply #27 on: September 07, 2015, 06:18:32 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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« Reply #28 on: September 07, 2015, 06:19:12 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 8840, product type: programmer, physician. Product id: 3387s-40, lot# v605118, implanted: (b)(6)2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6)2014, product type: extension. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
A manufacturing representative reported the patient¿s lead and extension connection eroded through their skin. The patient had symptoms of itching. Relevant medical history included parkinson¿s disease and movement disorders. The extension and lead connection was surgically buried to resolve the erosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976919
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« Reply #29 on: September 07, 2015, 06:19:59 AM »

Model Number 37601
Event Date 07/01/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v475602, implanted: (b)(6) 2010, product type: lead. Product id 3387s-40, lot# v475602, implanted: (b)(6) 2010, product type: lead. Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id neu_ptm_prog, product type: programmer, patient. (b)(4).

Event Description
A consumer reported the patient had a suspected infection. The reporter could see the white wire coming through the patient¿s skin down the side of their head and about two inches down they could see ¿puss or something¿ that looked very sore. The implantable neurostimulator (ins) site looked fine and it was the lead site that looked sore. The infection was not confirmed since the patient had not seen their health care provider (hcp). The patient had tried contact their hcp. The patient¿s indication for use was parkinson¿s dual and movement disorders. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4977035
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« Reply #30 on: September 07, 2015, 06:21:10 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v015431, implanted: (b)(6) 2007, product type: lead. Product id: 3387s-40, lot# v015431, implanted: (b)(6) 2007, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
A manufacturing representative reported the patient's implantable neurostimulator (ins) and extensions were going to be removed because the pocket was too small and the ins was breaking through the skin. The ins and extensions were to be removed to reduce the possibility of infection. The leads were capped and left implanted. The patient's indication for use is parkinson's dual.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4996828
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« Reply #31 on: September 07, 2015, 06:21:52 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/27/2015
Event Type Injury
Event Description
The company representative (rep) reported that the device was implanted due to parkinson's disease. The lead joint was found exposed on july 28th. The physician suspected its rejection. It was noted pre-operative that a package abnormality was found before opening. The device was inspected prior to use, no abnormality was found. The leads were replaced on july 31st. No fever and infection indication. No adverse event reported for the results of the lead replacement. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0gnkg, explanted: (b)(6) 2015, product type: lead. (b)(4) china. Device analysis for lead va0gnkg revealed no anomaly found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5018222
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« Reply #32 on: September 07, 2015, 06:22:36 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Product id: 7482-51, serial# (b)(4), product type: extension. Product id: 7482-51, serial# (b)(4), product type: extension. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative (rep) that the implantable neurostimulator (ins) and extensions were migrating through the patient's skin wall. The migration has been so great that the corner where the extensions go into the header block were visible on the outside of the patient. There was some infection at the site where the skin was broken. The patient was extremely thin, which led to this event. This has happened before to the patient and it was thought there has been a long standing infection. Pre and post op impedance tests were performed. The surgeon resected the infected skin and implanted the ins deeper under the small amount of remaining breast tissue. The infection required long term antibiotics, surgical wound. The issue was resolved at the time of the report. The hcp has no further information for the device manufacturer. The relevant medical history included parkinson's disease and low body weight. 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=5027730
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« Reply #33 on: September 07, 2015, 06:23:20 AM »

Model Number 7426
Event Type Death
Event Description
The consumer reported the patient had an infection and the wire in his chest came through. The patient also had an infection in his brain. The infection occurred the first of march. The physician removed the implant. The patient died on (b)(6) 2015 as a result of the infection. Relevant medical history includes parkinsons dual.

Manufacturer Narrative
Concomitant products: product id 748251, serial # (b)(4), implanted: (b)(6) 2002, product type extension; product id 3387-40, lot # l83936, implanted: (b)(6) 2002, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2002, product type extension; product id 3387-40, lot # l83936, implanted: (b)(6) 2002, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5039766
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