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Model Number 3389S-40 |
Device Problems
Shipping Damage or Problem (1570); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/13/2019 |
Event Type
malfunction
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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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Event Description
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Information was received from a healthcare provider (hcp), via a manufacturing representative (rep), regarding a patient with an implantable neurostimulator (ins).It was reported that when the surgeon inspected the lead prior to implant they noticed a difference in the connection of the contact to the plastic.There appeared to be a slight film around the edge.The lead was set aside and the surgeon proceeded with a different lead that looked normal/as expected when inspected.No environmental, external, patient factors were reported to contribute to the event.The issue was resolved at the time of the report.No patient symptoms or further complications were reported as a result of this event.
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Manufacturer Narrative
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Analysis of the implantable lead (lot #va1xfy5) revealed that there were no anomalies with the lead.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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