Concomitant medical products: product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Product id: 977a275, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 11-sep-2023, udi#: (b)(4) ; product id: 977a275, serial/lot #: (b)(4), ubd: 16-oct-2023, udi#: (b)(4) ; product id: 977a275, serial/lot #: (b)(4), ubd: 27-sep-2023, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 27-sep-2023, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 16-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported a lead kit issue.It was reported that during the same surgical procedure, 5 kits were found with missing contents that included stylets with the white cap, anchor removal tool, and the anchor.Factors that may have led or contributed to the issue were unknown.No actions were taken to resolve the issue.The issue was resolved.
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