(b)(4).Device was not implanted or explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing location: (b)(4).Manufacturing date: 18-jan-2017.Expiration date: 31-oct-2021.Part #: 298.801.01s, lot#: p242593 (sterile) - 1.7mm cable with crimp 750mm -sterile.Quantity 240.Inspection sheet for incoming final inspection meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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