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 |