Model Number 419688 |
Device Problems
Low Sensing Threshold (2575); Human-Device Interface Problem (2949)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: dtba1d1 icd, implanted: (b)(6) 2016.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 had significant decrease in function.Reprogramming was done, and the lead remain in use.The patient is a participant in the (b)(6) registry.No 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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