FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4210770
·
Received October 29, 2014
Report
- Report Number
- 2938836-2014-17240
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- September 23, 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
- FL, 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 DURING A ROUTINE FOLLOW UP, LOW, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. NO ANOMALIES WERE SEEN ON FLUOROSCOPY. PROGRAMMING CHANGE WAS MADE AND A SUCCESSFUL DFT WAS PERFORMED DURING DEVICE UPGRADE. THE PATIENT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692977 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |