MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION CONFIRM RX; DETECTOR AND ALARM, ARRHYTHMIA

Model Number DM3500

Device Problem No Display/Image (1183)

Patient Problem Dizziness (2194)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

According to the patient's history and physical by the physician's assistant, he "was found to have a one minute 'pause' by ambucor alert at 12:45 am for about 60 seconds.He was sleeping at time of event and denies position change as far as he is aware although he was sleeping.He does admit to prior syncope, but none at time of his alert on our monitor and did not have this during his hospital admit.He denies any syncope but admits to occasional lightheadedness which correlates to sinus rhythm with normal rate at time of symptoms on loop monitoring.I personally reviewed the tracings of his sjm confirm rx icm device.I personally called the sjm rep.Who came in today and reports he was not able to reproduce any signal loss with manipulation of device." the cardiologist reviewed the tracings as well and advised explant of sjm device and re-implant of mdt linq recorder.If he has recurrent events on mdt device, plan for permanent pacemaker.The patient then underwent removal of the confirm loop recorder, and had implant of a medtronic linq.There were no complications.

• Brand Name: CONFIRM RX
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7730965
• MDR Text Key: 115443186
• Report Number: 7730965
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 253