MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; NO MATCH

Model Number CD3357-40C

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

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

Event Date 12/22/2023

Event Type  Injury  

Event Description

It was reported that a patient presented in-clinic with an unspecified issue noted on the patient's implantable cardioverter defibrillator.The device was explanted and replaced on 22 dec 2023.The patient was stable throughout.

Event Description

New information received notes that the patient's device had migrated from its originally implanted position.This was the reason for the surgical intervention.

Manufacturer Narrative

The reported event of device migration could not be confirmed in the lab.Electrical, longevity, and visual analysis was normal with no anomalies found.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: NO MATCH
• 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: 18490106
• MDR Text Key: 332601843
• Report Number: 2017865-2024-00915
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CD3357-40C
• Device Lot Number: A000080044
• 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: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• 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
• Treatment: LEFT VENTRICULAR LEAD.; RIATA.; TENDRIL SDX.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male