Model Number 97714 |
Device Problems
Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Burning Sensation (2146)
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Event Date 05/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient with an implantable neurostimulator (ins) for the treatment of via a manufacturer representative.It was reported that since the ins was implanted, the pocket site has remained inflamed.It was reported that the patient felt a burning sensation coming from the ins in the pocket.It was also reported that the ins was overdischarged and had been dead for 4 months.The ins was explanted on (b)(6) 2019 and replaced with a new ins, which was implanted on right flank instead of the left.No further complications are anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from the manufacturer representative (rep) reported that the cause of the ins heating up inside of the pocket was not determined.There were no further complications reported or anticipated.
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Event Description
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The caller (manufacturer representative) stated the patient had an infection which caused the healthcare professional to move the pocket site in (b)(6) 2019.
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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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Search Alerts/Recalls
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