MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40QC

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661); Decreased Sensitivity (2534)

Patient Problem Ventricular Tachycardia (2132)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that an alert for ventricular tachycardia/ventricular fibrillation in 24 hours and non-sustained episode were seen on a remote transmission.Further review of the stored egms indicated ventricular undersensing during vt and oversensing on the secure sense far-field vector.The r-wave sensing has been declining since earlier this year.There was no allegation of lead or device malfunction.However, the issues indicated to be on the device as there was intermittent failure to sense ventricular tachycardia (vt) with asynchronous pacing.Low r-wave amplitude, unsuccessful antitachycardia pacing (atp) therapy and undersensing vt (predominantly post-paced) were also observed on the device.Programming changes were recommended.However, the device was explanted, the lead was capped, and the whole system was replaced on (b)(6) 2019.The patient recovered and was discharged.Related manufacturer reference number: 2938836-2019-12394.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9000785
• MDR Text Key: 157774457
• Report Number: 2938836-2019-13446
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2019

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: 07/31/2019
• Device Model Number: CD3361-40QC
• Device Lot Number: P000048141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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 STS
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 90