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

Model Number DM3500

Device Problems Premature Elective Replacement Indicator (1483); Data Problem (3196)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented remotely via merlin.Net transmission.Review of the battery data revealed the implantable cardiac monitor exhibited a diagnostics anomaly.The device exhibited an incorrect low battery longevity due to the device being subject to cold weather.The issue was resolved the following days and the battery gauge showed a normal reading.The patient's device will continue to be monitored.No patient consequences were reported.

Event Description

New information received noted that programming changes were made and eri status was successfully cleared.

• 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: 7579213
• MDR Text Key: 110398299
• Report Number: 2017865-2018-08453
• Device Sequence Number: 1
• Product Code: MXC
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000051767
• Other Device ID Number: 05415067027320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• 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 Age: 33 YR