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

Model Number DM3500

Device Problem Computer System Security Problem (2899)

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

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 implantable devices using bluetooth low energy for communication may be vulnerable to cyber-attach.

Manufacturer Narrative

A cybersecurity vulnerability investigation of a bluetooth system was performed by a research group as part of a cybersecurity quorum and information was reviewed for possible vulnerabilities.An internal investigation was initiated and is currently being performed to determine if there are any cybersecurity vulnerabilities involving abbott¿s bluetooth system.An investigation is being performed due to the bluetooth system being used in our insertable cardiac monitor system.Currently, there is no known cybersecurity vulnerability involving our devices.Upon review, the insertable cardiac monitor should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction or caused a serious event.If new information is received confirming a vulnerability, then a regulatory report will be submitted at that time.

• 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
• MDR Report Key: 9795891
• MDR Text Key: 182287624
• Report Number: 2017865-2020-03157
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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