Model Number 419588 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 during the implant attempt, the parameters on the left ventricular lead were not satisfactory.The lead was not used and a new lead was implanted in another target vein.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The full lead was returned, analyzed, and no anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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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