MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Type  malfunction  

Event Description

It was reported that a patient presented remotely with inadequate anti-tachycardia pacing noted for a patient ventricular tachycardia, resulting in a sustained arrhythmia.Corrective programming changes were made.No adverse patient consequences were reported.

• Brand Name: GALLANT DR
• Type of Device: NO MATCH
• 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: 17453707
• MDR Text Key: 320337782
• Report Number: 2017865-2023-37459
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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 Expiration Date: 04/30/2024
• Device Model Number: CDDRA500Q
• Device Lot Number: P000145964
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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: OPTISUREMRI; TENDRILLEADS
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 132 KG