MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; Pulse generator, permanent, implantable

Model Number CD2357-40Q

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

During testing in the laboratory, the device was found to have premature battery depletion.Interrogation of the device revealed the device was at the elective replacement indicator (eri) when received.A longevity calculation was performed and the battery depletion was premature based on the device usage.The device image indicated normal current drain during the implant period and no high current drain sources were found throughout bench and environmental stress testing.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.The battery analysis by the manufacturer found the battery was normal.The cause of premature battery depletion could not be determined.

Event Description

This report is to advise of an event observed during analysis.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: Pulse generator, permanent, implantable
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19111293
• MDR Text Key: 340865276
• Report Number: 2017865-2024-38433
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: (01)05414734508094(10)A000031266(17)181031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Model Number: CD2357-40Q
• Device Lot Number: A000031266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2016
• 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