MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-nov-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving morphine (1 mg/ml at an unknown dose) via an implanted pump.The indication for pump use was not provided.On (b)(6) 2018, during the implant procedure, the catheter got stuck in the needle hub and the stylet poked through the end of the catheter.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the needle was placed at a steep angle to gain access to the intrathecal space.The catheter started advancing caudal.The physician then removed the needle to pull the catheter back out to reposition when he could not pull the catheter out of the needle hub and noticed the stylet poking through the catheter at the end of the needle.The catheter was not implanted.Instead, a new catheter was grabbed/used and the next needle placement was much more shallow than the first.The issue was resolved.It was indicated that the hcp had no further information to provide regarding the event.No patient symptoms were reported.The patient status was reported as ¿alive ¿ no injury¿.No further complications were reported/anticipated.
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Manufacturer Narrative
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H3: analysis of the catheter revealed catheter body damage occurred to catheter body and or guidwire 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.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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