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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Pain (1994); Depression (2361); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was receiving bupivacaine (unknown concentration or dose) and dilaudid (hydromorphone) (unknown concentration or dose) via an implantable pump for non-malignant pain.It was reported that the patient had a mri (magnetic resonance imaging) on (b)(6) 2022 that was not related to the medtronic device/therapy.The patient stated that the mri almost "roasted me, my insides felt like they were on fire".The patient stated that the pump turned off due to the mri and did not turn back on for "468 hours".The patient stated that they went through withdrawal, depression, mania, and still felt like their insides were on fire.The patient noted that their healthcare provider was aware of their pump being off for so long.The patient stated that per the report, the pump supposedly restarted on thursday (b)(6) 2022; however, was not feeling any pain relief.The patient stated that they were supposed to meet with the doctor's pump nurse today (b)(6) 2022) for a pump reading to ensure it was working as programmed but the pump nurse did not show up.The patient noted that they are hard of hearing and was not aware if the pump was alarming. .

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 the patient who was calling to ask about damage to the pump if it had been stalled for ¿464 hours¿.The patient then reported that a week ago at their last refill they removed over 20 ml instead of the expected 4 ml.

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 consumer reporting they had a catheter dye study completed on (b)(6) 2023 and it was commented that the dye went down, but dye would not go up.The consumer was redirected to their healthcare provider to further address the issue at next appointment of the results of the dye study.Additional information was received from a healthcare provider (hcp) via a company representative (rep) reporting that the hcp stated the dye was coming out of the end of the catheter and only going down (not up).The rep was notified of the catheter dye study results on the day of the dye study, (b)(6) 2023.The patient had reported periods of not having efficacy.There were no pump logs that showed that anything was wrong with the pump.The pump was not alarming and there had been no issues at his refill appointments.The cause of the dye only going down, not up, was not reported to the rep.No additional information was reported.

Manufacturer Narrative

Continuation of d10: product id 8780, serial# (b)(6), implanted: (b)(6) 2021: product type catheter.Product id 8782, serial# (b)(6), implanted: (b)(6) 2021: product type catheter.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.

• 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: 15407731
• MDR Text Key: 306165429
• Report Number: 3004209178-2022-11700
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 01/23/2023
• Supplement Dates FDA Received: 09/15/2022; 02/20/2023
• Date Device Manufactured: 09/13/2021
• 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 Age: 66 YR
• Patient Sex: Male