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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received form a healthcare provider via a company representative regarding a patient receiving dialudid 0.2mg/ml at 0.44997mg/day and bupivacaine 7mg/ml at 15.7490mg/day via an implantable pump.It was reported that the volume was different then the expected at refill and loss of therapy effectiveness.There were no environmental, external or patient factors that may have led or contributed to the issue disclosed to the reporter.The diagnostics and troubleshooting performed was pumpogram was performed 01-jul-2022 by the physician demonstrating epidural locations of the distal catheter tip.The actions and interventions taken to resolve the issue was catheter revision surgery to be scheduled to place the catheter in the intrathecal space.The pump infusion rate set to minimum rate of 0.00961mg/ day.Surgical intervention did not occur but was planned.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 17-dec-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) via a company representative reported that a dye study was attempted on (b)(6) 2022 but the hcp was unsuccessful in aspirating the catheter, so the dye study was not completed.It was also indicated that the catheter had been placed in the epidural space by the hcp.There were no external factors that may have contributed to the issue.Surgery occurred today to revise the catheter.The catheter was explanted and replaced with new catheter in intrathecal space.Cerebrospinal fluid (csf) flow was observed at the placement of new catheter.The event was resolved.

Manufacturer Narrative

Continuation of d10: product id 8780 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: 14975112
• MDR Text Key: 295600608
• Report Number: 3004209178-2022-08689
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Date Device Manufactured: 01/29/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male