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

Model Number DM3500

Device Problems Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported that a symptom episode, was due to the patient pressing the symptom button on their app.It was unable to see the egm, it looked like baseline wander on an ecg.The total episode shows the device sensing appropriately for the first minute and few seconds.Then there was a noise event, and the device goes into noise mode.It remains in noise mode for the remainder of the episode.It was estimated that they pressed the button for few minutes after collapsing.It was believed that the patient may have had seizure like activity.The device did not trigger any episodes during this symptom episode.The patient was seen on (b)(6) 2022, in clinic and programming changes were made to help prevent noise mode or make it easier for the device to come out of noise mode.The programmer was displaying n/a where the heart rate should be displaying.There were also no markers and no intervals being displayed.Different sensitivity options were attempt and this happened at each one.The heart rate was unable to show up on the screen, it was believed to be loss of electrode contact.This would be consistent with the signal on the symptom episode.The patient condition was stable.

• 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: 15365785
• MDR Text Key: 305587248
• Report Number: 2017865-2022-22453
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000116846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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