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Author Topic: Allergic Reaction  (Read 2201 times)
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dennis100
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« Reply #30 on: May 14, 2019, 01:13:49 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient saw his neurologist to assess his current epilepsy treatment plan. The patient was referred for vns placement and thus clinic notes were received for review. The patient indicated that they had previously had a pacemaker device that was later determined to be a vns generator. The patient indicated that their generator had been explanted due to pain at some point. X-rays were reviewed and it was confirmed that the lead of the patient's vns lead was still implanted, but the generator was no longer implanted. No additional relevant information has been received to date.
 
Event Description
It was reported through clinic notes that the patient's generator had been taken out. The patient said that he had an allergy to the device, that it didn't work and that it bothered him. The patient also could pick up the lead under the skin; the lead reportedly bothered him and he couldn't straighten his neck. The device history records of the patient's generator was reviewed. The generator passed final quality and functional specification tests prior to final release. No further relevant information has been received to date. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6463667
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dennis100
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« Reply #31 on: June 06, 2019, 02:22:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2017
Event Type  Injury   
Event Description
Patient underwent generator and lead removal due to allergic reaction and extrusion. Patient also experienced vocal cord paralysis, which the surgeon suspects to be related to the allergic reaction. Patient's voice could be barely heard the day after he was implanted. Patient's voice has not improved much since then. The generator was removed because "it literally came out" of patient's chest. Per caregiver, patient has been a good healer in the past and has had multiple procedures without incident. The incision sites did not heal and there was oozing at the sites. The lead wire was sticking out of his chest as well and, so the lead was removed. Per surgeon, the vocal cord paralysis was noted prior to generator removal. The leads were not manipulated at that surgery and were left in the chest. The allergic reaction was present in both the chest and neck sites. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7824665
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dennis100
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« Reply #32 on: July 11, 2019, 12:59:07 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient experienced itching of the left neck and left chest where the lead and generator were implanted. The patient was referred to a dermatologist. It was determined that the patient had chronic atopic dermatitis that was initially determined to be unrelated to vns. It was later reported that the itching was related to a metal allergy. The itching sensation caused the patient to scratch his neck and chest incision wounds, causing redness to the site. The patient underwent lead and generator explant surgery. The device history records were reviewed for the lead and generator and revealed that both devices were sterilized according to specifications prior to release for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7662834
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dennis100
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« Reply #33 on: July 11, 2019, 12:59:59 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/17/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient had her device removed due to an allergic reaction to the device. The patient states that she knows that the body can react to some of the items that are placed in the body and thinks that she may be reacting to it. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7685621
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