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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 09/05/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: catheter.Product id: 8709sc, serial# (b)(4) , implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving unknown drug via an implanted pump.It was reported the patient had felt sick since monday, (b)(6) 2016 and thought it was the flu.Patient noted that the sickness had not gotten any better.The patient reported some weight loss and the device was sticking out.Patient is not sure if it's from the weight gain but doesn't think so.The patient was having pain in their stomach every time the patient stand up.Additional information was received from a consumer indicating that the patients pump was removed 7 months after implantation.It was reported that the patient got sick and could not drink properly for over a week.It was reported that the catheter remained implanted.The catheter was reported as resulting in a seroma on the patients back.It was noted that surgery was performed on the developed seroma.No further complications have been reported as a result of this 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7230427
• MDR Text Key: 98671519
• Report Number: 3004209178-2018-01720
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2016
• Date Device Manufactured: 12/07/2015
• 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