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

Model Number 8637-20

Device Problems Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)

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

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8709, lot# j0056604r, implanted:(b)(6) 2000, explanted:(b)(6) 2022, and product type: catheter.Product id 8578, serial# (b)(4), implanted:(b)(6) 2009, explanted: (b)(6) 2022, and product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), and udi#: (b)(4).Product id: 8578, serial/lot #: (b)(4), ubd: (b)(6) 2010, and udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving infumorph (25 mg/ml at 6.2 mg/day) via an implanted pump.It was reported that the patient was having a pump replacement procedure for end of battery life.During the procedure, the hcp noted no csf (cerebrospinal fluid) flow through the catheter access port and no flow of csf after cutting the catheter.The pump volumes had been correct, and no patient symptoms had been reported.There was a strange black colored substance around the collar of the pump connector after removing the existing catheter from the pump connector.There were no known environmental, external, or patient factors that may have led or contributed to the issue aside from the catheter being (b)(6).A new catheter was implanted, and the issue was noted to be resolved.Following the procedure, the infumorph dose was reduced to 3.1 mg/day.

• 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: 13719152
• MDR Text Key: 286918989
• Report Number: 3004209178-2022-03071
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• 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: 03/07/2022
• Date Device Manufactured: 07/21/2015
• 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
• Patient Age: 69 YR
• Patient Sex: Male