Continuation of d10: product id: 8780, serial# (b)(4), product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2023, explanted: (b)(6) 2023, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 17-oct-2024, udi#: (b)(4) ; product id: 8780, serial/lot #: (b)(4), ubd: 22-sep-2024, udi#: (b)(4).H3 ¿ analysis of catheter & guidewire (b)(4) found ¿catheter body ¿ damage occurred to catheter body and guidewire during implant procedure¿.Analysis of guidewire (b)(4) found ¿damage occurred to guidewire during implant procedure¿.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (.5 mg/ml at minimum rate) via an implanted pump.The patient¿s medical history was chronic pain.The indication for pump use was non-malignant pain.It was reported that during the implant procedure, when the hcp was pulling the stylet out of the spinal segment of the catheter, she was unable to pull it out/it was very difficult to pull out.The hcp tried to push the stylet back in and pull back, however, it was still very difficult, so she decided she wanted a new segment, and the entire spinal segment of the catheter was then replaced.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.Catheter (b)(4) with its guidewire and the guidewire for implanted catheter (b)(4) were returned for analysis.
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