MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37601 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Discomfort (2330); Insufficient Information (4580)
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Event Date 03/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that right after the second implant, the patient got an infection, and the doctor moved the implantable neurostimulator ins from the belly to the shoulder *see related reported event pe 705831781 infection (2020)*. the patient said that when implanted in the stomach, there was a long lead, and when the doctor moved the ins to the shoulder, they wrapped the excess leads around the device and had been that way for 3 years now, but it is much more uncomfortable.The patient wondered why the leads couldn't just be coiled separately and placed together on top of each other.The patient service specialist reviewed it was the doctor's discretion on how they have to do it. when leads were placed around the device, one side caused the wires to arc out on each side of the device which just took up more space and was to the touch, and they could feel the ridges and each time they had done this it was a little sore.The patient said that 'by wrapping a wire around another electrical device you create induction in the coiling'.The patient was scheduled to have the implant removed.
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Search Alerts/Recalls
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