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Author Topic: Deep brain stimulator - Protrude/Extrude  (Read 11883 times)
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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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