Model Number 439888 |
Device Problem
Failure to Capture (1081)
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Patient Problem
Heart Block (4444)
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Event Date 01/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: w4tr01 crt-p, implanted: (b)(6) 2021.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 left ventricular (lv) lead was not capturing causing the patient to experience atrioventricular block the lead was reprogrammed and remains in use.The patient is a participant in a 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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Concomitant medical products: w4tr01 crt-p, implanted: (b)(6) 2021.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 left ventricular (lv) lead was not capturing causing the patient to experience atrioventricular block the lead was reprogrammed and remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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