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 03/01/2019

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 during implant procedure, the insertable cardiac monitor exhibited error message.The device was not implanted and replaced.No patient symptom was reported.

Manufacturer Narrative

The reported event of an error message was confirmed by the lab, the pre elective indicator (pre-eri) flag was triggered due to exposure to cold temperature resulting in the error message.The device was located in (b)(6) and local temperature was below freezing at the time.Further testing was performed by clearing the pre eri flag and all test results were normal.Longevity assessments were within normal range of operation with appropriate longevity.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8423314
• MDR Text Key: 138899231
• Report Number: 2017865-2019-03873
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000059680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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