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

Model Number 8637-40

Device Problems Kinked (1339); Unstable (1667); Material Integrity Problem (2978)

Patient Problem Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving morphine (5 mg/ml at 0.668 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2018 the patient was scheduled for a pocket revision because her pump was flipped at her last refill.Upon opening the pocket, it was observed that the majority of the catheter was tangled and twisted to the point that it could not be reused.The catheter was cut at the spine.The tip was observed to be at the same level as implant and flow was observed at the catheter in the spine.The tangled and twisted section of the catheter was removed; a new piece of catheter was attached to the remaining spinal segment; and the revised catheter was attached to the pump.It was noted that the patient must have been flipping the pump for quite some time.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the patient was flipping pump.The issue was resolved.The patient status was reported as ¿alive ¿ injury¿.It was noted that the hcp had no further information regarding the event.No further complications were reported/anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7361027
• MDR Text Key: 103137258
• Report Number: 3004209178-2018-05510
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• 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: 03/21/2018
• Date Device Manufactured: 01/25/2017
• 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: 68 YR