MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2357-40C

Device Problem Under-Sensing (1661)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2020

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 the implantable cardioverter defibrillator exhibited undersensing resulting in non-sustained right ventricular oversensing.Further information was requested however, was not provided.

Event Description

New information received stated that additional non-sustained ventricular oversensing episodes caused by undersensing on the implantable cardioverter defibrillator were observed remotely on (b)(6), 2021.Programming changes were recommended.There were no patient symptoms reported.Further information was requested but were not provided.

• Brand Name: FORTIFY ASSURA DR ICD, US
• 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: 11181593
• MDR Text Key: 227214818
• Report Number: 2017865-2021-02241
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• 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: 02/10/2021

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: 09/30/2016
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: 4796219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR