FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 4030766
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14726
- Event Type
- Injury
- Date Received
- August 22, 2014
- Date of Event
- July 22, 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
- IT
- 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 FOLLOW UP, INTERROGATION OF THE DEVICE REVEALED EPISODES VF DUE TO NOISE ON THE VENTRICULAR CHANNEL. HIGH, OUT RANGE PACING LEAD IMPEDANCE WAS ALSO OBSERVED. THE LEAD WAS DIAGNOSTICALLY IMAGED AND NOTED TO BE NORMAL. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509704 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |