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

Model Number CDDRA500Q

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Event Description

Related manufacturing reference number: (b)(4).It was reported that the patient presented remotely on (b)(6) 2022.It was noted that the patient exhibited seven ventricular tachyarrhythmia episodes that were determined to be consistent with heart failure by the cardiac monitoring company.No shock therapy was delivered.It was noted by the cardiac monitoring company that the device was functioning normally.On (b)(6) 2022, the patient's wife called emergency services after the patient became non-responsive.It was noted that the previous night, the patient had difficulty breathing.When emergency services arrived, it was noted the patient was in cardiac arrest.Emergency services attempted to resuscitate the patient but the patient passed away on (b)(6) 2022.The patient's causes of death were cardiac arrest, ischemic cardiomyopathy and cardiac tachyarrhythmia.There was an allegation that the implantable cardioverter defibrillator (icd) contributed to the patient's death.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.A technical services investigation was unable to be performed due to lack of data.

• 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: 18833293
• MDR Text Key: 336833834
• Report Number: 2017865-2024-34035
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CDDRA500Q
• Device Lot Number: S000081436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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: 2088TC/52 TENDRIL STSLEADS
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG