Model Number 429888 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Stimulation (1412); Hiccups (1899); Palpitations (2467)
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Event Date 12/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient was experiencing "palpitations and a hiccup feeling" during a echocardiogram at a routine in-clinic device check.It was further reported that the left ventricular (lv) lead exhibited diaphragmatic stimulation.The lead was reprogrammed and remains in use.The patient is a participant in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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