FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 4153614
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16314
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 2, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT INCREASES IN HIGH VOLTAGE LEAD IMPEDANCE AND PACING LEAD IMPEDANCES WERE OBSERVED. HIGH CAPTURE THRESHOLD, POOR SENSING, AND FRACTURE WERE ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED DURING DEVICE CHANGEOUT DUE TO NORMAL ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631629 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |