Model Number DTBA1D1 |
Device Problems
Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 02/13/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced a potentially inappropriate shock.Upon review it was noted that there was right atria l (ra) lead and right ventricular (rv) lead oversensing, ra lead undersensing and potential electromagnetic interference from the cardiac resynchronization therapy defibrillator (crt-d). the ra lead, rv lead and crt-d remain in use. no further patient complications have been reported as a result of this event.
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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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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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It was further reported that the patient received radiofrequency kyphoplasty (rfk) which was identified as the cause of the confirmed electromagnetic interference which lead to the inappropriate shocks.
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Search Alerts/Recalls
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