MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM3500

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

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

Event Type  Injury  

Event Description

It was reported during in clinic follow up that the insertable cardiac monitor (icm) could not be interrogated via inductive means.Premature battery depletion was suspected.The device was explanted and successfully replaced.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported event of premature discharge of battery could not be confirmed.The reported event of failure to interrogate was confirmed.The device was received with no telemetry at eos (end of service).Analysis performed on the session records indicated device performed normally.The implant duration meets 75% longevity indicating normal battery depletion.Device stored session records constantly, contributing to a faster battery depletion.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: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17720459
• MDR Text Key: 323086332
• Report Number: 2017865-2023-42717
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Model Number: DM3500
• Device Lot Number: S000084394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 61 KG