Model Number DTPA2QQ |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 04/08/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient continued to receive defibrillation shocks after a magnet was placed over the cardiac resynchronization therapy defibrillator (crt-d) to suspend tachyarrhythmia therapies.The patient was also noted to be experiencing abdominal spasms, possibly from phrenic nerve stimulation from the left ventricular (lv) lead.The crt-d and lv lead 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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Continuation of d10: 5076-45 lead implanted (b)(6) 2022; 6935m55 lead implanted (b)(6) 2022.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 died the same day.It was noted that the patient was in hospice care for a non-cardiac health condition.Prior to the death, the patient was transported to the emergency department.When they arrived at the emergency department a magnet was already placed over the device and the device was in suspended mode.All device therapies were programmed off at the emergency department.
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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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Search Alerts/Recalls
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