FDA Adverse Event
Malfunction
Summary report: N
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 13690894
·
Received March 8, 2022
Report
- Report Number
- 2017865-2022-04592
- Event Type
- Malfunction
- Date Received
- March 8, 2022
- Report Date
- March 8, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVY
- UDI-DI
- 05414734507332
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: SECTION H6 FAILURE TO CAPTURE A070101-000 SHOULD HAVE BEEN ADDED.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-04589. IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED OVERSENSING NOISE AND HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) AND ATRIAL LEAD. HIGH DEFIBRILLATION IMPEDANCE AND AN INAPPROPRIATE SHOCK WAS ALSO REVEALED ON THE RV LEAD. CHEST X-RAY REVEALED DISLODGEMENT DUE TO TWIDDLING ON THE RV AND ATRIAL LEAD. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313109 | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LDA210Q/65 | A000111381 | 05414734507332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | FORTIFY ASSURA DR ICD. |