MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Electromagnetic Interference (1194); Failure to Deliver Energy (1211)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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B3: event date is not known.Please see b5 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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Event Description
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Information was received from a patient regarding an implantable neurostimulator (ins).The patient reported that their ins turned off after they walked through a security screener at walmart.The patient stated that they could feel themselves "going downhill really fast," so they made an appointment with their healthcare provider (hcp) and the hcp turned the ins back on.After the ins was turned on, the patient stated that the ins took it's time but they eventually got back to normal.The patient's relevant medical history included that the last time they spoke with their neurologist they were told that the stimulation was turned up to its maximum, and if the stimulation was increased the patient would run the risk of getting a stroke.For that reason, the patient has not had their stimulation increased.
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Search Alerts/Recalls
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