FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 4153706
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16533
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 23, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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 PROPHYLACTIC FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS CAPPED AND REPLACED DURING DEVICE CHANGE OUT FOR NORMAL ERI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631655 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |