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

Model Number CD3357-40Q

Device Problems Pacing Problem (1439); Environmental Compatibility Problem (2929)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited an inappropriate rate increase.Further information was requested but was unavailable at this time.

Event Description

New information notes the issue was discovered by a hospital device technician.Prior to the magnetic resonance imaging (mri) scan, the implant was programmed as ordered by the physician orders to voo mode without the presence of a field representative.The mri scan was conducted in an off-label mri environment.The issue resolved.No further action was required.The patient was stable before, during and after the incident.*(voo mode induces sequential asynchronous ventricular pacing, without inhibition by intrinsic events.).

• 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: 18839733
• MDR Text Key: 336924401
• Report Number: 2017865-2024-34154
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: CD3357-40Q
• Device Lot Number: A000115176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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
• Treatment: DURATA LEAD RIGHT VENTRICULAR LEAD; QUICK FLEX LEAD; TENDRIL ST OPTIM LEAD
• Patient Age: 86 YR
• Patient Sex: Female