Catalog Number LR-EVN-13.0-RL |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 12/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The pma/510(k) # - k141148.Device - the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of investigation.
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Event Description
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It was reported that during the course of the lead extraction procedure, a small bleed occurred in a minor branch of the innominate vein.Intervention was required in the form of a chest drain and both leads were extracted successfully.According to the initial reporter, after putting the drain in and continuing with the lead extraction, "patient is fine." the leads had been implanted for over 17 years.No additional patient consequences were reported.
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Event Description
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See additional mfr narrative for the investigation of this event.
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Manufacturer Narrative
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Pma/510(k) # - k141148.Investigation summary: the affected product was not returned for this complaint and therefore a physical investigation could not be performed.The instructions for use was reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium'.This complaint event is a known failure mode and will be monitored and trended through the complaint handling and post market processes.A device history record review was performed including the manufacturing and quality control records.All steps were documented per procedure by trained personnel and there were no signs to indicate that a nonconforming device was released to the field.This complaint could only be confirmed through customer testimony.
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Search Alerts/Recalls
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