FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3781943
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-09963
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- February 24, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED DURING FOLLOW-UP, A FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS ON THE LEAD. NO ELECTRICAL ANOMALIES WERE OBSERVED. THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259398 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |