Model Number 37612 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Breast Cancer (1759); Erythema (1840); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
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Event Date 04/17/2021 |
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 multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that there was intense heating of the ins during the charging session.The patient had pain and swelling of the breast, which led to an explant of the system.An activa pc implantable neurostimulator (ins) was implanted on the right side.A biopsy showed a 10 cm mass on the left breast and it was determined the patient developed grade 2 invasive breast carcinoma of the nonspecific type around the site of the implant.The issue was not resolved at the time of the report.Additional information was received indicating there was a history of breast cancer within the family but not a direct history as it was a distant aunt.It was stated that intense heating of the ins during recharging session was suspected to have speeded the development of the breast cancer.
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that there was intense heating of the ins during the charging session.The patient had pain, discomfort, redness, and swelling of the breast, which led to an explant of the system.An activa pc implantable neurostimulator (ins) was implanted on the right side so that the patient could still receive therapeutic benefit.A biopsy showed a 10 cm mass on the left breast and it was determined the patient developed grade 2 invasive breast carcinoma of the nonspecific type around the site of the implant.The issue was not resolved at the time of the report.
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Manufacturer Narrative
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B5: corrected event description to include report of redness and discomfort.H6: corrected to include report of redness and discomfort, in addition to the previously reported codes.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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