MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

It was reported that during interrogation, prior to implant procedure, the implantable cardiac monitor displayed an error message while still in the box.The device was not implanted.

Manufacturer Narrative

Analysis of device image indicated that memory corruption occurred during the manufacturing process.Further testing was performed by reloading the product code and all tests results were normal, memory corruption could not be reproduced.A manufacturing anomaly may have occurred that resulted in the reported error message due to memory corruption.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7828397
• MDR Text Key: 118626825
• Report Number: 2017865-2018-12719
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000055844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2017865-10/11/19-001-C
• Patient Sequence Number: 1