MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving an unknown drug, of an unknown concentration at an unknown dose rate via an implantable pump for unknown indications for use.It was reported that the pump was in reset mode and could not be updated.¿ it was noted that the pump started in minimum flow rate and they could not start the normal infusion again.A service code 101, service code 87, and service code 97 were displayed via the healthcare provider's clinician programmer tablet.¿ it was being considered that the code 101 and 87 seemed to indicate the pump encountered a problem, and that the code 97 indicates a low reservoir was reached.Checking and correcting the volume of the reservoir if a refill was performed was being considered.¿ checking that the low reservoir volume is set (default of 2 ml) and then updating the pump was also being considered.¿ if that did not resolve the issue, then attempting to activate the patient boluses and trying to update was considered and if the update is possible then remembering to disable the patient activated dose feature was reviewed.¿ additional information was later received from the company representative on 2021-sep-21.¿ it was noted that the healthcare provider could solve the problem with the model 8840 clinician programmer before the company representative was able to contact them.Regarding why the hcp was unable to update the pump with the clinician programmer tablet, it was being considered that it could possibly be due to either the user had to re-confirm the low reservoir volume or because of some pending changes that were requiring confirmation.¿ it was also being considered that another cause could be due to a memory error of the pump (fa921), and that this could be resolved by activating the patient's personal therapy manager, updating the pump, and then again disabling the ptm to update a second time the pump.¿ it was reviewed that using the model 8840 clinician programmer would be an alternative.

Event Description

Additional information was received from a foreign healthcare provider via a company representative.It was reported that the physician had decided to update the pump with the model 8840 programmer.The patient and pump serial number were clarified.The pump was administering morphine with concentration 5.0 mg/ml at a dose rate of 0.0387 mg/day as of (b)(6) 2021.As of (b)(6) 2021 the pump administered morphine with concentration 10 mg/ml at a dose rate of 2.101 mg/day.The low reservoir alarm was set at 2.0 ml and elective replacement indicator as of (b)(6) 2021 was 45 months.

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

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 from a foreign healthcare provider via a company representative.The patient¿s gender was clarified.The patient¿s age and weight at the time of the event was unavailable.The implant date of the pump was unknown.The cause of the event/pump reset was undetermined.It was noted that the patient did not experience any symptoms related to the event.The patient was further noted as having died due to cancer.The death was indicated as not having been related to the pump or therapy.The date of death was unknown.

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 via a company representative.The company representative was unable to confirm if the reset occurred while updating with the clinician programmer.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12529852
• MDR Text Key: 273379609
• Report Number: 2182207-2021-01656
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 12/06/2021; 12/17/2021; 12/22/2021
• Supplement Dates FDA Received: 12/17/2021; 12/21/2021; 12/22/2021
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female