MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Discomfort (2330); Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that their interstim does not help, and they want the implant removed.The patient stated they were more unhealthy when they got their device.The patient reported, since they lost weight, the device sticks out and causes discomfort.
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Manufacturer Narrative
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Event date is not known.Please see for approximate date range, if applicable.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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