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

Model Number 8637-20

Device Problem Positioning Problem (3009)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-feb-2018, 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 (500 mcg/ml at 75 mcg/day) via an implanted pump.It was reported that the patient¿s catheter was replaced to place the catheter tip at a new location due to reported lack of effect with initial catheter.There was no known environmental, external, or patient factors that may have led or contributed to the issue.The diagnostics/troubleshooting performed was noted to be that a new pump trial was performed, and the patient reported improved pain relief.During the procedure, the catheter was removed, and a new catheter was implanted.The pump was also replaced at the time of surgery.The issue was noted to be resolved and it was indicated that the hcp had no further information to provide regarding the event.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10817257
• MDR Text Key: 215573287
• Report Number: 3004209178-2020-19675
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• 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: 11/05/2020
• Date Device Manufactured: 12/22/2015
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR