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

Model Number DM2102

Device Problems Failure to Capture (1081); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/22/2018

Event Type  Injury  

Event Description

The device was not recording cardiac rhythm episodes and went into back-up mode.The device was explanted and replaced.The patient was stable.Further information regarding the implant date was unavailable.

Manufacturer Narrative

Upon receipt, communication could not be established between the device and the programmer because the battery was depleted.Since no communication could be established, the device image and episode data was unable to be retrieved.The device was tested with automatic test equipment (ate) which revealed normal device characteristics.The device¿s implant date is unknown; therefore, the longevity estimation could not be performed.The cause of the battery depletion is undetermined.The reported event of the device in hardware back-up mode was not confirmed in the laboratory.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7293505
• MDR Text Key: 100834354
• Report Number: 2017865-2018-02972
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: DM2102
• Device Catalogue Number: DM2102
• Device Lot Number: 4436722
• Other Device ID Number: 05414734502573
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention