ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUAL-PURPOSE DUO-DECAPOLAR (20 ELECTRODES),; CATHETER, STEERABLE
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Model Number 401932 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)
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Event Date 08/15/2018 |
Event Type
Death
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer reference number: 9680001-2018-00129, 9680001-2019-00004, 3005334138-2019-00020, 3005334138-2019-00021, 3005334138-2019-00022, 3005334138-2019-00023.Following an ablation procedure, the patient experienced a cerebral infarction and expired.During the procedure the patient was anticoagulated with heparin and the act monitoring was made in 30-minute intervals.After the procedure the patient did not wake up from anesthesia and subsequently expired.There were no performance issue with the device.Further information has been requested regarding the cva.
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Event Description
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Following an ablation procedure, the patient experienced a myocardial infarction and expired.During the procedure the patient was anticoagulated with eparine and the act monitoring was made in 30-minute intervals.After the procedure, the patient did not wake up from anesthesia and heart enzymes and heart catheterization confirmed the myocardial infarction.The patient subsequently expired.No further information is available at this time.
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Search Alerts/Recalls
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