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

Model Number DM3500

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

It was reported that the implantable cardiac monitor (icm) exhibited premature battery depletion prior to procedure.The icm was not used.There were no patient involvement.

Manufacturer Narrative

The reported event of premature discharge of battery could not be confirmed.The device was received in normal working conditions with battery voltage above elective replacement indicator (eri).Analysis performed, indicated normal device functionality.At a maximum shelf storage time of 18 months, longevity is reduced by approximately 5 months.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.Performed dhr review to ensure that each manufacturing and inspection operation was performed.The product passed all quality control tests prior to its distribution.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15313428
• MDR Text Key: 300793908
• Report Number: 2017865-2022-21749
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000081843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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