FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3903702
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12812
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN HOSPITAL FOR A DEVICE CHANGE OUT DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WILL BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE REVIEW OF THE X-RAY PROVIDED TO ST. JUDE MEDICAL, THE CONDUCTORS DO NOT APPEAR TO BE EXTERNALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380298 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |