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

Model Number DM3500

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

Rn called tech services to report a patient who presented via merlin.Net device transmission with a 5-hour af episode.Upon review of the egm, tse discussed the episode was falsely triggered due to frequent pvcs the patient was experiencing.The patient will continue to be monitored, and rn and physician will discuss possible medication adjustment.

Event Description

It was reported that the patient presented remotely via merlin.Net transmission with atrial fibrillation (af) episode.Upon interrogation, the af episode was falsely triggered due to premature ventricular contractions (pvcs).Possible medication adjustment was discussed.The patient will be monitored.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8904610
• MDR Text Key: 154708689
• Report Number: 2938836-2019-12510
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000049563
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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