FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4884751
·
Received July 1, 2015
Report
- Report Number
- 2938836-2015-27654
- Event Type
- Malfunction
- Date Received
- July 1, 2015
- Date of Event
- May 28, 2015
- Report Date
- May 28, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED UNDER FLUOROSCOPY DURING NORMAL PACE GENERATOR CHANGE OUT. PATIENT WAS ASYMPTOMATIC. THE LEAD WAS TESTED WITH NORMAL ELECTRICAL FUNCTION AND NO ANOMALIES. THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427456 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1580/60 | 0002184655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |