MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2020 |
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 professional (hcp) via a manufacturer¿s representative (rep) regarding the implantable drug infusion device.The drug being delivered was 500 mcg/ml baclofen (unknown) at 49.96 mcg/day.It was reported that the patient missed their refills and the pump has been empty for over a month now.The hcp would like to move forward with pump replacement since they don't feel comfortable filling the pump again.The rep wanted to review options to silence the alarm.It was reviewed that there were options to do permanent shutdown or to program pump into thinking it has reservoir volume in order to silence it.The rep discussed with the hcp and decided they will program pump with water as the drug, 40 ml reservoir volume, minimum rate and put notes to indicate pump is empty but updating to silence alarm.The patient has been on orals and they will schedule a replacement in the near future.Troubleshooting was unable to be performed, none needed at this time the patient was redirected to their healthcare provider to further address the issue.
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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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