MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pocket Erosion (2013); Discomfort (2330)
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Event Date 02/20/2024 |
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.
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Event Description
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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction it was reported that the patient had a device site infection.This issue was resolved.Antibiotics were required and the device was removed.The battery was breaking through the skin.Both the battery and the lead were explanted as a single using directly from the pocket site.
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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that after the procedure the patient had signs and symptoms concerning for infection at the surgical site (tenderness, sore, redness, weeping).Cultures were collected.The patient was treated with antibiotics but failed to improve.The site worsened, progressing to dehiscence of the wound, and the device had to be removed.The surgeon noted concerns for infection and inflammatory process.It has been noted the patient had an allergy to nickel.This device is reportedly nickel-free, but the surgical team noted a concern for possible allergic reaction.
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Manufacturer Narrative
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E4: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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