MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Pumping Stopped (1503)
|
Patient Problems
Underdose (2542); Insufficient Information (4580)
|
Event Date 11/09/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a foreign consumer via a manufacturer representative regarding a patient receiving intrathecal hydromorphone 1900.0 mcg/ml at 1055.5 mcg/day, marcaine 2250.0 mcg/ml at 1249.9 mcg/day, and baclofen 500.0 mcg/ml at 277.76 mcg/day via an implantable pump.It was reported that a motor stall occurred and did not recover for 48 hours.Logs confirmed that a motor stall occurred on (b)(6) 2020 at 22:08.The patient was in the hospital to monitor underdose symptoms.On (b)(6) 2020, the patient¿s intrathecal medication was updated to hydromorphone 1750.0 mcg/ml at 987.6 mcg/day (conflicting information stated morphine 1750.0 mcg/ml at 987.6 mcg/day), marcaine 2000.0 mcg/ml at 1128.6 mcg/day , and baclofen 500.0 mcg/ml at 282.16 mcg/day.Pump replacement was planned but had not yet been scheduled.The issue was not resolved.The patient's status was alive - no injury.Environmental/external/patient factors that may have led or contributed to the issue included the drugs inside the pump being ¿morphine, baclofen, and marcaine¿.The patient did not have an mri scan and was not exposed to any strong electromagnetic interference (emi).Information regarding the patient¿s weight, medical history, and other medications was unavailable.
|
|
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
|
Additional information received confirmed that the intrathecal medication was hydromorphone, not morphine.Specific symptoms experienced were unknown.Replacement had not been scheduled yet (as of 2020-nov-15) as the doctor was first going to check the catheter to determine if an all system replacement was needed or only the pump.
|
|
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
|
Additional information was received.The new pump was implanted and everything was okay.
|
|
Event Description
|
Additional information received clarified that the patient was monitored in the hospital before starting underdose symptoms, but ended up experiencing underdose symptoms after being released from the hospital because they didn't take their oral medication, which was reportedly not related to the device.Additional information then received on (b)(6) 2020 indicated that the pump was replaced that day and would be returned for analysis.
|
|
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.
|
|
Manufacturer Narrative
|
H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Destructive analysis identified residue in the motor gear train.Analysis identified wearing on the upper shaft of gear number one.Medtronic developed a design change to reduce motor shaft wear and received regulatory approval for the change.Medtronic began distributing pumps with this design change in august 2017.H6: fdm/annex b updated to b01.Fdr/annex c updated to c07.Fdc/annex d updated to d1103.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.
|
|
Search Alerts/Recalls
|
|
|