MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM2102

Device Problems Failure to Capture (1081); Failure to Sense (1559)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that during implant procedure, the implantable cardiac monitor exhibited loss of capture.The physician attempted a different position but was unsuccessful.The device was no longer used and replaced.No patient symptoms were reported.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).Final analysis found an anomalous hybrid which resulted in a sensing anomaly.

Event Description

Corrected information the implantable cardiac monitor exhibited loss of sensing and not loss of capture.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4560290
• MDR Text Key: 20367258
• Report Number: 2017865-2015-02373
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• PMA/PMN Number: K081365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: DM2102
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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