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

Model Number DM3500

Device Problem Data Problem (3196)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

It was reported that during interrogation prior to the procedure, the implantable cardiac monitor (icm) exhibited an error message.The icm was replaced and the procedure continued with new icm on (b)(6) 2022.No patient involved reported.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Reported event of software anomaly was confirmed.The device was received for analysis.Analysis of device image indicated memory corruption which is consistent with an anomalous integrated circuit.No other anomalies were found.

• 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: 15499965
• MDR Text Key: 301095372
• Report Number: 2017865-2022-39643
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000146443
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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