MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Electromagnetic Interference (1194); Failure to Interrogate (1332); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/17/2024 |
Event Type
malfunction
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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 healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the device was not responding to messages.Tss reviewed the ins battery and asked if the patient had noticed any changes in their symptoms; the patient hadn't noticed any changes.The caller noted the patient had an mri scan 3¿4 months ago and everything was working fine at that point.Troubleshooting performed during call: ensured they were using the correct app, ensured communicator is not plugged in, and repositioned communicator over ins multiple times.Tss also suggested they try turning external equipment off and then back on.Issue not resolved during call; recommended pt follow-up w/ hcp.
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