MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Pumping Stopped (1503); Vibration (1674); Insufficient Information (3190)
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Patient Problem
Discomfort (2330)
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Event Date 04/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 provider (hcp) via a company representative regarding a patient receiving lioresal (2000 mcg/ml at 400 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.It was reported that the patient had no therapy from the pump.The doctor had adjusted the concentration of the drug as well as changed the infusion rate to get therapy, but it was unsuccessful.A dye study of the catheter was performed on (b)(6) 2021 and it was determined that the catheter was working properly.There was no blockage in the catheter.The patient had also felt a vibration from the pump every 3-4 minutes starting on (b)(6) 2021.The vibration could not be felt externally by the patient¿s caretakers or hcps.The pump was replaced due to a possible pump malfunction.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The issue was not resolved at the time of the report.It was noted that after the pump was explanted, it was dropped twice from 4 feet by the circulator attempting to put the pump in a biohazard bag.
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Event Description
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Additional information was received from a company representative via the return paperwork which indicated that the reason for product return was ¿pre-mature motor stall¿.
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Manufacturer Narrative
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H3 ¿ analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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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Manufacturer Narrative
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The returned device passed all testing in the laboratory and no anomalies were identified.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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