MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40

Device Problem Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

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.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-01016.It was reported that the patient presented for revision of the right ventricular lead due to noise, and low defibrillation impedance measurements.During the procedure there was, and shorted output stage detection (sosd) alert was triggered on the implantable cardioverter defibrillator.The lead and device were both explanted and replaced.The patient tolerated the procedure well without complication.

Manufacturer Narrative

Sosd was confirmed in the device image.Out of range defibrillation impedance (hvli) was confirmed on the bench.The cause of the sosd and hvli anomaly was found to be due to a shorted output transistor.

• Brand Name: FORTIFY VR, U1.6 DF1 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: 9633384
• MDR Text Key: 176490064
• Report Number: 2017865-2020-01017
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• 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: 06/22/2020

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: 08/31/2014
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: 3967100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RIATA ST OPTIM LEAD; RIATA ST OPTIM LEAD