MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Discomfort (2330); Electric Shock (2554)
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Event Date 04/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.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 urge incontinence, urinary/bowel dysfunction.It was reported that they have had a shock sensation 2 or 3 times since the implant.Patient stated they feel a little sting here and there, like a little static shock inside their body.Patient mentioned they have an appointment with the medtronic representative on monday 29th-apr- 2024 in their hcp office.The patient was redirected to their healthcare provider to further address the issue.Patient declined device education, stating they knew how to use the equipment.
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Event Description
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Additional information was received from the manufacture representative.They reported that the follow up email sent to them was the first that they have heard of this issue.The steps taken were they discussed the issue with the patient and hcp.They agreed to re-program the patient and/or turn device off to determine if caused by stimulation.The issue was resolved.
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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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