FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3801364
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10977
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- February 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED VIA MERLIN.NET TRANSMISSION WITH NON-SUSTAINED LEAD NOISE AND A NON-SUSTAINED VENTRICULAR FIBRILLATION EPISODE. RV LEAD NOISE WAS SUSPECTED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND THE DEFIB PORTION REMAINS ACTIVE. PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278463 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7011/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |