MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problems
Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/05/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a consumer (con) via a company representative (rep) regarding a patient who was receiving baclofen with a concentration of 1250 mcg/ml, and morphine with a concentration of 5.0 via implantable pump.It was reported that the patient's pump reservoir was empty.The hospital is supplementing oral medication.There were no known external factors.The alarm was silenced, and drugs were changed to minimum rate.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The rep reported that the pump was ran empty due to the patient being in the hospital and not being able to visit the office for a refill.The doctor has considered potentially removing the pump.The pump is still empty at this time at the time of the report.The patient is still in the hospital, and they are supplementing oral medication.
|
|
Search Alerts/Recalls
|
|
|