FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 4153702
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16432
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- December 14, 2013
- 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
- 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 THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP. REVIEW OF THE EGMS SHOWED A VF EPISODE, AND NOISE IN THE RV CHANNEL AND IN THE ATRIAL CHANNEL. POSSIBLE EXTERNAL SOURCE WAS DISCUSSED. THE PHYSICIAN WILL FOLLOW UP WITH THE PATIENT IN ONE MONTH. NO ADVERSE CONSEQUENCES TO THE PATIENT AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631745 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |