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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problems Cognitive Changes (2551); Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported the patient had a refill on (b)(6) 2022 and the expected residual volume and actual residual volume were 0.9cc in difference.It was reported they had changed the dose from 2000 mcg/day to 4000 mcg/day and the patient had tolerated it well.It was reported the pump dosing was increased by 4% on (b)(6) 2023 and the new dose was 1560 mcg/day from 1499 mcg/day.It was reported the patient had a refill on (b)(6) 2023 with no change in concentration or dose.It was reported there was a significant difference in the reservoir volume with an expected residual volume of 3.9 cc versus an actual residual volume of 12 cc.It was reported the patient did not have any symptoms at this time.It was reported the patient presented to the hospital from (b)(6) 2023.It was reported the pump was interrogated and then aspirated.It was reported the difference between the expected and actual residual volume was approximately 3.8 cc.It was reported the pump was reprogrammed with the accurate volume and no changes were made to the dosing.Itwas reported on (b)(6) 2023 the patient presented to the emergency department (ed) and had reported that their pump was "making a noise" that was continuous in nature.It was reported on (b)(6) 2023 the patient called their clinic and expressed the same pump concerns and was redirected to the ed where the pump was interrogated again.It was reported the expected residual volume was 6.3 cc and the actual residual volume was 11 cc.It was reported the patient underwent a side port aspiration and had positive return.It was reported a catheter dye study was performed and there was no discontinuity or extravasation noted and no catheter issues were noted.It was reported on (b)(6) 2023 the pump was removed and a new 20 ml pump was placed.

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

Upon further review, this information is related to the information pertaining to regulatory report # 3004209178-2023-03426.Please refer to this file going forward.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

It was reported that on (b)(6) 2023, for the patient's normal refill, they expected 3.9ml from the reservoir and aspirated 12ml.The rep reported on (b)(6) 2023 the patient went to the emergency room and they accessed the pump expecting there would be 19ml and got back 16ml.The rep stated that they were concerned with the patient having seizures and altered mental status at that time.Technical services reviewed the possibility that the pump reservoir was not aspirated entirely at that time.Technical services inquired if any bubbles had been seen.The hcp did not have the details.The rep stated that today, 2023-mar-01, they expected 6.3ml from the reservoir and pulled back 11ml.The rep stated that there were no alarms in the logs.The hcp stated that the patient also reported hearing some whirling or "some type of weird noise" yesterday, 2023-feb-28, coming from the pump.Technical services reviewed that the pump does make noise at it turns its wheels.The hcp said it was more so than usual, but he did not hear it.The hcp stated that the patient's spams were at baseline, but there was no itching or bad spasticity.The hcp stated that at the patient's last pump repl acement, there was some catheter discontinuity and they had to revise the catheter so he did not rule out that there may be a partial catheter kink or occlusion currently happening.The hcp would be doing diagnostic testing on the catheter and possibly replace the pump and the catheter depending on the findings.Additional information received on 2023-mar-07 from a healthcare provider (hcp) reported the previously mentioned volume discrepancies and that the catheter port study showed no catheter breaks/extravasation and imaging showed no kinks.Additional information received reported the pump was replaced.The catheter aspirated fine as well.

Manufacturer Narrative

H3: the pump was returned and analysis identified a propellant anomaly.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

Ananlysis determined that there was a propellant anomaly.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: 16678132
• MDR Text Key: 312677232
• Report Number: 3004209178-2023-04533
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Female