MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Device Alarm System (1012); Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2021 |
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 consumer regarding a patient receiving hydromorphone at 5.2 mg/day via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that last night about 6 pm his pump started alarming; it stopped alarming about midnight; and it had not alarmed since.The patient described the critical alarm.He stated that he had not had an mri lately and he had tried to call his doctor but had not heard back from them yet.Additional information was received from the consumer indicated that they continued to hear the alarm.It was reported that the logs were checked and no errors were found in the logs.It was noted that the alarm sounded like a backup car, a busy phone to a lot of different odd alarms that are not similar to the pump alarms.Additional information was received from the device manufacturer indicated that the patient reported seeing code 8476 on their ptm and the pump had been alarming.The pump was interrogated and even though the patient reported hearing an audible alarm on (b)(6) 2021 there were no events from that date.A stall was seen on the logs from (b)(6) 2021 and recovery, another stall on (b)(6) 2021 that lasted until (b)(6) 2021.The pump recovered on (b)(6) 2021 but stalled again today (b)(6) 2021.The caller states the patient will be managed with oral medication and have the pump replaced in the next two weeks.The pump was updated to min rate mode today in the event it recovers on its own again.
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Manufacturer Narrative
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H3: analysis of the pump revealed pump motor gear train anomaly; corrosion and or wear and or lubrication; stall due to shaft bearing.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 received indicated that the pump was replaced.
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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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