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

Model Number CD3357-40C

Device Problem Over-Sensing (1438)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported the patient presented with an implantable cardioverter defibrillator (icd) that exhibited post-paced t-wave oversensing (pptwos).No changes or intervention was reported.The patient condition is unknown.

Event Description

Additional information received indicates the patient presented in clinic where the issue was discovered.Programming changes were performed.The patient was in stable condition.

• 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: 19003841
• MDR Text Key: 338907209
• Report Number: 2017865-2024-37215
• 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: Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: CD3357-40C
• Device Lot Number: A000020869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2016
• 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: TENDRIL
• Patient Age: 71 YR
• Patient Sex: Female