MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Energy Output Problem (1431); No Device Output (1435)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/14/2024 |
Event Type
Injury
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Manufacturer Narrative
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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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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 patient stated they had their system removed on valentine's day by hcp at (b)(6).When asked, patient said that the complete system was removed.Patient would like to have their handset wiped.Warm transferred to healthcare it.Outbound call was made to patient after reviewing previous call.When asked, patient said that the reason for the device being removed is because the therapy wasn't working and stated that when tried to turn therapy off, it wasn't turning therapy off and same issue when trying to turn therapy back on.Patient said that it was turned off about a year before it was removed.Patient said that was replaced with an [other manufacturer] system.Patient service specialist documented information given during the call.
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Search Alerts/Recalls
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