The event date is estimated to be (b)(6) 2019.The results/method and conclusion codes along with the investigation results will be provided in the final report.Concomitant medical products and therapy dates: model: 3660, scs ipg, therapy date: (b)(6) 2019.Model: 3156 (x2), scs leads, therapy date: (b)(6) 2019.Model: 3186, scs lead, therapy date: (b)(6) 2019.Model: 3341 (x2), scs extensions, therapy date: (b)(6) 2019.Model: 3383, scs extension, therapy date: (b)(6) 2019.
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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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