MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 7425 |
Device Problems
Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
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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 patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated that if they do not turn stimulation off after a while, it twists up their back and they can barely walk.Patient noted the stimulation is supposed to be for their legs.Patient noted that where they live has strong electrical pulses and they think the electrical pulses turn the stimulation on.Patient noted one time they had to go to the er because it hurt so bad, and they were able to turn the stimulation off with a magnet.Patient noted that the doctor told them that the manufacturer tried calling the patient several times but gave up because there was no answer, and the patient does not have a voicemail.The patient was redirected to their healthcare provider to further address the issue.
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Search Alerts/Recalls
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