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

Model Number 8637-40

Device Problems Fluid Leak (1250); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 03/07/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (40 mg/ml at 9. 009 mg/day) via an implanted pump. It was reported that the patient was placed on the surgery schedule today suffering possible withdrawal type symptoms and pain following the pump replacement procedure a few weeks ago. After opening the pump incision, the catheter was found to still be securely connected to the pump. The catheter was then disconnected from the pump, and it was discovered that there was no backflow. The hcp explored further and followed the catheter into the tissues to discover a small mass of granulated damp powder believed to possibly be the medication from the pump. He then decided to replace the catheter. The proximal end of the existing catheter including the cap all the way to the butterfly anchor was removed. He then opened a new catheter and proceeded to make a needle entry at interspace l2/l1. He guided the new catheter posterior to interspace t8/t9 and then secured it with an injection anchor. Substantial backflow was noted. Lastly, he located the old catheter at the butterfly anchor and folded it over and tied it off. There was no backflow before or after tying it off. The new catheter was tunneled around to the pump and connected before closing all incisions. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be the recent pump replacement procedure. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Concomitant products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2003, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 10-apr-2005, udi#: (b)(4). 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: 13861500
• MDR Text Key: 287688465
• Report Number: 3004209178-2022-03604
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 03/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/23/2022 Patient Sequence Number: 1