FDA Adverse Event Death Summary report: N

DISPOSABLE CABLE EXTENSIONS

MDR report key: 21748602 · Received April 1, 2025

Report

Report Number
2017865-2025-39062
Event Type
Death
Date Received
April 1, 2025
Date of Event
March 11, 2025
Report Date
April 1, 2025
Manufacturer
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Product Code
DSA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT PASSED AWAY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2698538 DISPOSABLE CABLE EXTENSIONS CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 4051L 2400408

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Death