MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Seroma (2069); Insufficient Information (4580)
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Event Date 04/11/2023 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver unknown morphine with a concentration of "2" and a dose of "0.489" and bupivacaine with a concentration of "6" and an unknown dose.It was reported that, during a replacement surgery on (b)(6) 2023 for normal elective replacement indicator (eri)/end of service (eos), the physician incised the pump pocket.Upon opening the pump pocket, the physician remarked that the smell was "horrible".There was a very pungent smell and grayish fluid in the pump pocket.The pump pocket was swabbed/cultured for testing.The physician irrigated the pump pocket and spinal pocket copiously with normal saline and a betadine rinse.There were no external factors known that may have led or contributed to the issue.The pump and catheter were explanted on (b)(6) 2023.A possible implant would occur on a future date.Additional information received indicated that the culture of the pump pocket came back negative.The doctor planned to monitor incision healing and go back for a replacement at an unknown date.As of (b)(6) 2023, the replacement surgery had not been scheduled yet.At the time of this report, the issue was resolved and the patient status was "alive-no injury".The patient's weight and medical history were asked but were unknown.
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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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