MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Date 04/02/2012 |
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 around (b)(6) of 2012 they had a fever in the middle of the night and had a seizure.At that time, the patient noticed that the left-side ins (implanted in their chest) was very swollen, so they went to clinic to have the left-side ins checked.At the clinic, the patient learned that their symptoms were due to an infection of the left-side ins implant site.As a result, the patient stated that the left-side ins was replaced.However, after the new ins was implanted, the incision site was not healing up well (the patient figured it was due to weakened tissue from having multiple incisions in the same spot).Thus, the ins was replaced again and implanted in the patient's abdomen, and this time it was replaced with a rechargeable ins.The patient stated that their skin seemed to heal up after the rechargeable ins was implanted in their abdomen.Refer to manufacturer report 2182207-2022-01737 for related device.
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