FDA Adverse Event
Injury
Summary report: N
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 23441379
·
Received October 31, 2025
Report
- Report Number
- 2017865-2025-1003856
- Event Type
- Injury
- Date Received
- October 31, 2025
- Date of Event
- October 8, 2025
- Report Date
- January 29, 2026
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVY
- UDI-DI
- 05414734507325
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: PLEASE RETRACT THIS REPORT 2017865-2025-1003856, THE SAME ISSUE WAS PREVIOUSLY REPORTED AS 2017865-2025-1003023.
Description of Event or Problem · 0
IT WAS REPORTED A PATIENT PRESENTED WITH CARDIAC PERFORATION, CONFIRMED VIA ECHOCARDIOGRAPH. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND THE PATIENT WAS STABLE.
Description of Event or Problem · 0
IT WAS REPORTED A PATIENT PRESENTED WITH CARDIAC PERFORATION, CONFIRMED VIA ECHOCARDIOGRAPH. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AFTER DRAINAGE INTERVENTION, AND THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2299020 | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LDA210Q/58 | A000169070 | 05414734507325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention | ATRIAL LEAD| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) |