Model number/catalog number: sc-8416-70, serial number: (b)(4), batch/lot number: 21355313, model/catalog description: artisan mri paddle lead 70 cm.Model number/catalog number: sc-1160, serial number: (b)(4), batch/lot number: 357495, model/catalog description: spectra wavewriter ipg kit.The explanted devices were not returned to bsn as they were kept by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices were found to be satisfactory.
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