FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 4153569
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16344
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 18, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THA DURING LV LEAD REPLACEMENT DUE TO LOSS OF CAPTURE, FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS ON RV LEAD. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631460 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |