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

Model Number 8637-20

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978); Positioning Problem (3009)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted infusion pump.The pump was used to deliver unknown morphine 10mg/ml at 1mg/day.It was reported that, during an initial implant procedure, the stylet broke through the tip of the catheter.The physician was attempting to place the catheter intrathecally and felt that he was getting resistance.When he pulled the catheter out, the stylet was sticking out of the side of the tip of the catheter.It was unknown when the stylet broke through the catheter tip; it was noticed after the physician attempted insertion.It was noted that the spinal segment of a new catheter was used for the spinal part of the implant.The pump segment and anchor were used from catheter serial number hg7jquy15.The cause of the stylet sticking out of the catheter tip was unknown.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.In regards to diagnostics/troubleshooting performed, there were none; the physician used a new catheter.At the time of this report, the issue was resolved and the patient status was "alive-no injury".The patient's weight and medical history were asked but were unknown.

Manufacturer Narrative

Continuation of d10: product id 8780, serial# (b)(6), implanted:(b)(6) 2024, product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 21-nov-2025, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18949890
• MDR Text Key: 339151838
• Report Number: 3004209178-2024-07499
• 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: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Date Device Manufactured: 02/06/2024
• 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 H11...."
• Patient Age: 77 YR
• Patient Sex: Female