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

Model Number DM2100

Device Problem Reset Problem (3019)

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

Event Date 06/14/2017

Event Type  malfunction  

Event Description

It was reported that the device was in hardware backup mode.No further information is available.

Event Description

New information received indicated that the patient was ok and no adverse consequences.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6720238
• MDR Text Key: 80252453
• Report Number: 2017865-2017-05806
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K081365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2017
• 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