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

Model Number 8637-20

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dyspnea (1816); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2021

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient receiving unknown drug via an implanted infusion pump.It was reported the patient was in the icu because the pain pump overdosed the patient this past wednesday.

Manufacturer Narrative

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 received from a consumer reported the patient was receiving morphine, fentanyl, and baclofen via an implantable pump.It was reported the patient went to the er because of a fall and had an mri.The customer received a call at 11 pm reporting that the patient had an opioid overdose and was given narcan that they responded to.It was noted the only source of opioids was the pain pump.The customer was concerned about the integrity of the pump.It was noted the patient went to see the managing hcp for a refill a couple weeks ago and they pulled out what was expected from the pump and the pump logs showed the expected stall and recovery.Caller reported the only explanation they can think of is the pump might have had a slight backflow when it was stalled and then delivered a bit more medication once it recovered leading to the overdose.Caller reported the hcp that gave the patient narcan said since the patient responded to it right away then the only thing they can think of is the overdose being related to the pump.Pss reviewed functionality of pump and mri compatibility.Caller expressed concerns for future mri's.Caller stated patient's previous pump did not give this issue when patient had an mri.Pss reviewed they can request for a rep present at mri scan to check on pump and redirected to hcp for further questions.

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.

Event Description

Additional information received from a manufacture representative reported the patient fell and hit their head on (b)(6) 2021.An ambulance brought the patient to the hospital.The patient had been having dementia issue the became severe in early on (b)(6) and affected their balance.On (b)(6) 2021, the patient had an mri and at 11pm the patient was having difficulty breathing and seemed to be having a seizure.The patient was brought to the icu and given a narcan drip, which they responded to.The patient was still getting narcan on (b)(6) 2021.The hcp reduced the pump 50% on (b)(6) 2021, as the patient had an opioid overdose.The patient was doing a lot better and was aware and communicating.They were hopeful the patient would get out of the icu on (b)(6) 2021.Information was received from multiple sources (manufacturer representative, friend/family member) regarding a patient who was receiving unknown drug via an implantable pump for non-malignant pain.It was reported that the patient went to the emergency room (er) because of a fall and had an magnetic resonance imaging (mri).It was reported that the patient had an opioid overdose, narcan was administered which they responded to.The patient stated their only source of opioids was the pain pump.The patient was concerned about the integrity of the pump.

• 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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12983524
• MDR Text Key: 282104672
• Report Number: 3004209178-2021-18431
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2022
• Date Device Manufactured: 07/28/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female