Model Number DTMA1QQ |
Device Problems
Appropriate Term/Code Not Available (3191); Data Problem (3196)
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Patient Problems
Fall (1848); Limb Fracture (4518); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/23/2024 |
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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It was reported that the left ventricular (lv) lead exhibited high thresholds and capture could not be confirmed.It was noted that the patient fell and broke their arm.The patient reported that they felt that the cardiac resynchronization therapy defibrillator (crt-d) was "wonky" and was activating "more and harder" than normal.A device check was performed and it was observed that the left ventricular (lv) lead exhibited high thresholds and capture could not be confirmed.It was further noted that the crt-d interrogation report displayed question marks instead of the threshold value for an observation related to the device feature that automatically monitors pacing thresholds.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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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 by the patient that since the fall they feel like a ¿baby kicking me¿ that started in their back and has now moved to their chest.The patient noted that they can see the thumping.
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Search Alerts/Recalls
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