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

Model Number ABBOTT ICD

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)

Patient Problem Arrhythmia (1721)

Event Date 01/24/2023

Event Type  Injury  

Event Description

It was reported the patient presented remotely via merlin.Net.Review of the transmission revealed the implantable cardioverter defibrillator (icd) had withheld high voltage therapy for ventricular tachycardia (vt) after incorrectly discriminating it as supraventricular tachycardia (svt).Programming changes were implemented.The patient condition was unknown.

• Brand Name: ABBOTT ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16588094
• MDR Text Key: 311735411
• Report Number: 2017865-2023-14358
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABBOTT ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention