Investigation of this event is pending and a supplemental report will be sent upon its completion.Continuation of d10: ddpa2d4 icd implanted (b)(6) 2021 407652 lead implanted (b)(6) 2014 6935m6 lead implanted (b)(6) 2014, additional products: d1: heartware ventricular assist system ¿ battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-jan-2023 /serial#: (b)(6), udi#: (b)(4), d9: no h3: no h4: mfg date: 24-jan-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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