MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Disconnection (1171); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8709sc lot# (b)(4).Implanted: (b)(6) 2009.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4).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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Event Description
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Information was received from a consumer (con) via company representative (rep) regarding the patient receiving morphine (did not asked dosage/25 mg/ml) dilaudid (did not asked dosage/4 mg/ml) infusion pump.The indication for use was non-malignant pain, chronic low back pain, and failed back surgery syndrome.It was reported that at the normal replacement, they went to remove the sc connector from the 8709 and the cup inside the connector piece broken off and so they needed to replace the connector with 8578.There were assisted with back table prime volume and drips were seen so show the drug had been primed in both the pump and the new 8578 piece.The existing catheter was then connected to the new 8578/pump.
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Event Description
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Additional information was received from a company representative (rep) reporting that the patient was asked but unknown.The company representative said, ¿once the catheter piece broke off, it was removed and replaced with a pump segment.¿ the issue was resolved.The customer discarded the broken piece.The provided information was not confirmed with the healthcare provider.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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