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Author Topic: Deep brain stimulator - Stroke  (Read 29757 times)
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dennis100
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« Reply #60 on: April 19, 2015, 02:54:22 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7495lz51, serial# (b)(4) implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: extension. Product id: neu_unknown_lead, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
It was reported that the system was explanted due to an infection on (b)(6) 2015. Additional information indicated that the patient had a stroke and the deep brain stimulator system was explanted. No problems had existed with the deep brain stimulator technology or therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4580173
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dennis100
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« Reply #61 on: June 08, 2015, 06:54:07 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had a seven year history of parkinsonism complicated by high dose use of entacapone and levodopa. The patient's implant of the system in the subthalamic nucleus was complicated by right frontal hemorrhagic stroke with bi-frontal injury evident on ct. The stroke resulted in left sided paresis and cognitive dysfunction amplified by two seizures. The patient was treated at ucsf. The patient was doing well with isolated control of parkinsonism and their health care professional (hcp) was monitoring their cognition.

Manufacturer Narrative
Concomitant products: product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708640, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead; product id 3389s-28, lot # va0gxxs, implanted: (b)(6) 2014, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755853
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dennis100
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« Reply #62 on: June 08, 2015, 06:54:48 AM »

Model Number 3387S-40
Event Date 04/20/2010
Event Type Injury
Event Description
It was reported the patient had a mini stroke and subsequent "bleen" when the lead was 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.

Manufacturer Narrative
Product id: 37601, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: neu_ptm_prog, serial# unknown, product type: programmer. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762603
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dennis100
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« Reply #63 on: July 15, 2015, 11:36:54 PM »

Model Number 3387S-40
Event Date 06/10/2015
Event Type Injury
Event Description
It was reported that there was an intracranial bleed that had occurred during the procedure for the lead implant. The lead was left in place when the patient had started showing signs of stroke and the case was aborted. Hospitalization was required. X-rays were done. A computerized tomography (ct) revealed a large bleed. The patient had signs of weakness on the contra lateral side and some facial drooping. The patient was admitted to the intensive care unit and at no point was surgical intervention planned. The patient was alive with injury. The intracranial bleed was 3cm in diameter. Patient symptoms at the lead location included headache, stroke, loss of reflexes and paralysis. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id neu_unknown_ext, serial# unknown, product type: extension, product id neu _ins_stimulator, serial# unknown, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4875535
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dennis100
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« Reply #64 on: July 15, 2015, 11:37:36 PM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3389s-40, lot# va05216, implanted: 2015 (b)(6); product type lead product id 3389s-40, lot# va05216, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4).

Event Description
It was reported that the patient had three epileptic or transient ischemic attack (tia) episodes in the last two months since the interstim device was on. The patient referred to tia as ¿mini strokes¿. Further follow-up is being conducted to obtain information. If additional information is received, a follow-up report will be sent. Information unrelated to this event was included in a several separate pes. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4871395
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dennis100
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« Reply #65 on: July 15, 2015, 11:38:31 PM »

Model Number NEU_INS_STIMULATOR
Event Type Death
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, implanted: (b)(6) 2012 product type: lead. Product id: neu_ins_stimulator, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4) product type; programmer, patient. Product id: 3387s-40, lot# v989563, implanted: (b)(6) 2012 product type: lead. Product id: 37085-60, serial# (b)(4) product type: extension. Product id: 3387s-40, lot# v911924, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4) product type: extension. (b)(4).

Event Description
It was reported that the patient was having two implantable neurostimulators (inss) placed in (b)(4) 2013. They had gone in and placed the 1st one, the patient had begun to bleed but had recovered from that. They had gone back in to revise the 2nd one and the patient had a bleed at the tip of the lead and had suffered a stroke a few hours later. The patient never recovered from the stroke. The patient died on (b)(6) 2013. The cause of death was not device related but had occurred during the procedure implant. Reference manufacturer¿s report number: 3007566237-2012-02621, for patient's similar issues that were experienced in (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872134
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dennis100
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« Reply #66 on: August 08, 2015, 10:08:20 AM »

Model Number 37602
Event Date 06/08/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0343947v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported that the patient had a mini stroke. The patient had a computerized axial tomography (cat) scan was done and it was believed to be related to the device along with the mini stroke. The patient had a doctor appointment scheduled on the day following the date of this report. There was also a bulging on the right side of the head where the wire was behind the ear. Further follow-up is being conducted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4908657
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dennis100
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« Reply #67 on: August 08, 2015, 10:08:54 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the patient had a stroke and was going to have an mri. 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. Refer to manufacturer report #3004209178-2015-13997.

Manufacturer Narrative
Concomitant products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387s-40, lot# v822991, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# va0cl8j, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. 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=4936198
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dennis100
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« Reply #68 on: September 07, 2015, 08:00:16 AM »

Model Number 7426
Event Date 12/01/2004
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2004, product type: implantable neurostimulator. Product id: 3387-40, lot# j0428226v , implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 3387-40, lot# j0444274v, implanted: (b)(6) 2004, product type: lead. (b)(4).

Event Description
The consumer reported that few months after his 2004 bilateral implant, he got an infection under the skin and the left lead had to be pulled out. They waited 2-3 months for the infection to clear and they were putting in a new lead but they had to stop surgery. The patient had a stroke and brain bleed. He also had to go to rehab to learn how to walk again. The left lead was put in at a later time but the patient still suffered from migraines and headaches. The patient was indicated for movement disorders. No further information was provided. 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=4994759
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dennis100
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« Reply #69 on: September 07, 2015, 08:01:12 AM »

Model Number 7426
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative
Product id 7482a51, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 3387s-40, lot# v255260, implanted: 2009 (b)(6); product type lead. (b)(4).
Manufacturer Narrative
(b)(4).

Event Description
Additional information from the consumer noted that the patient had an ocular stroke and was blind in one eye. The patient did not know what led to it, she woke up in the morning and she could not see. The patient did a study on 2015 (b)(6) where the events were first noted. The indication for use is essential tremor. No further information was provided.

Event Description
It was reported that the patient had a stroke approximately one year prior ((b)(6) 2014). No interventions, diagnostics, 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=4960698
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dennis100
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« Reply #70 on: September 07, 2015, 08:01:57 AM »

Model Number 37612
Event Date 07/15/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), implanted:(b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v015069, implanted:(b)(6) 2007, product type: lead. Product id: 748240, serial# (b)(4), implanted:(b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v021705, implanted:(b)(6) 2007, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative that there was a ¿patient with a stroke. ¿ it was later stated that the patient had been admitted to the hospital on (b)(6) 2015 with ¿stroke like symptoms¿ and they wanted the company representative to come and check the device to rule that out as a possible problem. Therapy impedance was checked and all values were within normal range. In addition, the battery had been in full time use since the previous (b)(6), and the patient reportedly charged their battery every other day and kept it above the 50% range. No interventions/actions were noted to have been taken to resolve the issue, but it was unknown if the issue had resolved. It remained unknown what led to the event or how the issue was identified. Further follow-up for diagnostics, actions/interventions, and patient outcome is being conducted. If additional information is received, a follow-up report will be sent. Indications for use: parkinsons dual movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4966301
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dennis100
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« Reply #71 on: September 07, 2015, 08:03:10 AM »

Model Number 37602
Device Problem No Known Device Problem
Event Date 07/08/2015
Event Type Death
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted:(b)(6) 2014, product type: implantable neurostimulator. Product id: 3389s-40, lot# v079662m implanted:(b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted:(b)(6) 2008, product type: extension. Product id: 3389s-40, lot# v079662, implanted:(b)(6) 2008, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted:(b)(6) 2008, product type: extension. (b)(4).

Event Description
The healthcare provider (hcp) reported that the patient had an unrelated hip surgery on (b)(6) 2015, after which the patient suffered a stroke overnight. Her indications for use were parkinson¿s dual and movement disorders. The hospital was considering moving her to hospice. The hcp did not know if the stroke had anything to do with the therapy and noted there was a risk of stroke with all surgery. The hcp was calling in because the patient¿s implantable neurostimulators (ins) were turned off for the surgery and needed someone to turn stimulation back on. The patient¿s family did not know how to work the programmer and the hcp could not be responsible for it. A manufacturer representative (rep) later reported that the patient was seen and she may have turned the inss on herself after the surgery. She apparently had her programmer with her at the time and when the rep went to turn them back on, they were already on. It was unclear if the stroke was device or therapy related and the patient outcome was not reported, so additional information was requested. If additional information is received a supplemental report will be sent. Refer to manufacturing report #(b)(4) as the patient had two inss.

Event Description
Additional information received from a health care provider (hcp) reported the patient did not have an mri, instead they had two brain ct scans done. Both ct scans came back negative for stroke. The patient's neurologist reviewed the ct scans again and said the scans showed a stroke. The cause of the stroke was not determined, but the patient had surgery and the hcp felt that was a risk factor. No actions or interventions were taken. The patient had a fatal stroke and there was nothing that could be done. The patient was put on dnr/hospice and they passed away on (b)(6) 2015.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976801
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dennis100
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« Reply #72 on: September 07, 2015, 08:03:56 AM »

Model Number 37602
Event Date 07/17/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3389s-40, lot# v062134, implanted: (b)(6) 2007, product type: lead. (b)(4).

Event Description
The consumer reported that the patient had a ¿clot¿ near where the stimulator was located. The patient suffered a stroke and was now completely paralyzed. The patient had a feeding tube because they could not swallow and could not speak. The patient¿s wife had turned the device off and stated it would not be turned on again. The results of any diagnostic testing were not provided and the patient¿s ultimate outcome remains unconfirmed. Follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indication for use: parkinsons dual <(>&<)> movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976978
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