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

Model Number 8637-40

Device Problems Kinked (1339); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacture representative (rep) via a healthcare provider (hcp) regarding a patient receiving unknown drug via an implanted pump.It was reported the patient had a catheter revision and pump replacement on (b)(6) 2017.It was noted the cause of the pump and catheter replacement was that they tried to do a dye study, but were unable to push anything through the catheter.It was mentioned a catheter kink was found during revision which had caused back pressure to the pump and resulted in the pump as well as the catheter being replaced.The issue was resolved once the pump and catheter were replaced.The rep noted they still had the pump and catheter in their procession and was going to be sending it back.The patient's weight was not known.

Manufacturer Narrative

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7238697
• MDR Text Key: 98961959
• Report Number: 3004209178-2018-02007
• 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,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• 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: 06/25/2018
• Date Device Manufactured: 09/30/2016
• 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: 31 YR