FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4221110
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17475
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- August 11, 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
- TX, 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 THAT DURING A ROUTINE GENERATOR CHANGE-OUT, AN ALERT FOR LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. OVERSENSING DUE TO ELECTROSURGERY, AND AN OUTPUT ANOMALY WERE OBSERVED. THE LEAD WAS CAPPED AND REPLACED. PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702415 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1590/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | (B)(4),(B)(4),(B)(4),(B)(4) |