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Author Topic: Allergic Reaction  (Read 1799 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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