Model Number 0295 |
Device Problems
Pocket Stimulation (1463); Defective Device (2588)
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Patient Problems
Device Overstimulation of Tissue (1991); Perforation (2001)
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Event Date 03/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that the patient with this right ventricular (rv) lead experienced diaphragmatic stimulation.In addition, the physician also suspected possible lead perforation.The lead was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the perforation as reported patient code cannot be confirmed by product analysis but was assigned cause which is known inherent risk of device, based on the field report.The muscle or pocket stimulation allegations were not confirmed by product analysis but were assigned cause which is known inherent risk of device, based on the field report.During analysis several abrasions were noted on the lead in an area on the lead which should have been located within the heart while implanted.The abrasions are consistent with some type of crushing damage.This damage will be addressed with new lines of code.
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Event Description
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It was reported that the patient with this right ventricular (rv) lead experienced diaphragmatic stimulation.In addition, the physician also suspected possible lead perforation.The lead was explanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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