MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
Event Type
malfunction
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving an unspecified medication(s) of unspecified concentration(s) at unspecified dose rate(s) via an implantable pump.It was reported that the physician was concerned that the synchromed pump had a premature battery life. the pump was having to be replaced after 4 years and the physician wanted an explanation. pump failure having occurred prematurely was further indicated. regarding factors that may have led or contributed to the issue, it was noted that the physician was using morphine, bupivacaine, and clonidine, and further stated was using all the time and only noticed the premature malfunction of the pump having only 4 years of life. the patient was due for a revision on (b)(6) 2023 for pump failure. the issue was not resolved as of on (b)(6) 2021.
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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.
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Manufacturer Narrative
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H1 correction: the type of reportable event was changed from previously being a reportable malfunction to now a reportable serious injury.H6 correction: the previously applied annex f / imf code f26 has been replaced with f1905.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.
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Event Description
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Additional information was received from a company representative.The pump is scheduled for replacement on (b)(6) 2023.The pump is to be returned to the manufacturer for analysis.
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Search Alerts/Recalls
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