Manufacturer report numbers 1627487-2024-07533, 1627487-2024-07534, 1627487-2024-07535.It was reported that due to ineffective stimulation, surgical intervention to address the issue took place for explant of three leads.One was able to be removed, one was found to be fractured on fluro and was left intact in situ, and the third was fractured while being removed and a fragment remains in situ for possible surgical removal at a future time.
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Correction: section h6- the medical device problem code should have been a0401-break rather than 1261 - material fragmentation.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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