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

Model Number CD3357-40C

Device Problems Failure to Charge (1085); Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 05/14/2021

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

Related manufacturer reference number: 2017865-2021-21228.It was reported the patient presented remotely.Upon review of the transmission, it was observed the right ventricular lead had low defibrillation impedance.The system was tested in clinic to see normal values, but programming changes were completed to address the impedance value.A year later, the patient presented in clinic having received shock therapy that failed to treat the arrhythmia.The arrhythmia self terminated moments later.An alert was observed for possible lead damage.No further intervention had been completed.The patient was stable.

Event Description

New information received indicated the device was explanted and the right ventricular lead was capped and both replaced on (b)(6) 2021.No reported patient consequences.

• 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
• MDR Report Key: 11967994
• MDR Text Key: 255170468
• Report Number: 2017865-2021-21229
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000040644
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION; DURATA STS OPTIM ACTIVE FIXATION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100