FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 23406265
·
Received October 28, 2025
Report
- Report Number
- 2017865-2025-1003561
- Event Type
- Injury
- Date Received
- October 28, 2025
- Date of Event
- October 10, 2025
- Report Date
- November 6, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVY
- UDI-DI
- 05414734502818
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: H10.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003560. IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH MIGRATION DUE TO TWIDDLERS AND THE RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH DISLODGEMENT DUE TO TWIDDLERS. THE ICD AND LEAD WERE EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2025. POST-PROCEDURE THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1551922 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 7120Q/58 | A000169027 | 05414734502818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |