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

Model Number CD2357-40Q

Device Problems Failure to Capture (1081); High impedance (1291); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow up.Upon interrogation it was noted that the implantable cardioverter defibrillator (icd) was exhibiting high defibrillation impedance, high pacing impedance, decreased p-wave amplitude sensing and high capture thresholds that resulted in failure to capture.The icd was explanted and new icd was implanted.The patient was in stable condition.

Manufacturer Narrative

The reported event of impedance and sensing anomaly was confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.Interrogation of the device revealed the device was above the elective replacement indicator (eri) when received.Visual inspection of the device did not reveal any anomaly that could contribute to the reported event.During testing, the failure was lost and could not be reproduced.The cause of the reported event could not be determined.

• 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: 18472053
• MDR Text Key: 332373707
• Report Number: 2017865-2024-00683
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: CD2357-40Q
• Device Lot Number: S000079459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• 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.; TENDRIL STS.
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 64 KG