MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40Q

Device Problems Intermittent Capture (1080); Over-Sensing (1438); Insufficient Information (3190); Data Problem (3196); Interrogation Problem (4017)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that the patient presented for a procedure.During the procedure, the implantable cardioverter-defibrillator (icd) exhibited intermittent capture, oversensing sensing noise, an a unspecified set screw anomaly.The icd was also unable to be interrogated by the programmer and was resulting in an error message.The physician opted to explant and replace the icd, a new device was successfully implanted.There was no patient consequences.Further information was requested but not received.

Manufacturer Narrative

The reported event of sensing, interrogation, programmer error message, and set screw anomalies anomaly could not be confirmed in the lab.The device was returned for analysis.Interrogation of the device revealed the device was above the elective replacement indicator when received.Electricidal analysis was normal and no anomaly was detected.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 12919234
• MDR Text Key: 281665874
• Report Number: 2017865-2021-38230
• 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: 12/30/2021

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: 01/31/2023
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000105012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2021
• 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 Age: 60 YR
• Patient Sex: Male