FDA Adverse Event
Malfunction
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 3791130
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10395
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- February 26, 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
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC AFTER RECEIVING A VIBRATORY ALERT. HIGH, OUT OF RANGE AND LOW, OUT OF RANGE HV LEAD IMPEDANCE WAS OBSERVED. NO ISSUES WERE SEEN WITH PROVOCATIVE TESTING. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269235 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |