FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4153671
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16323
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 7, 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
- 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 DEVICE REPLACEMENT, EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD WAS CAPPED AND A PORTION WAS CUT DUE TO THE SET SCREW COULD NOT BE SCREW OUT FROM THE DEVICE. THE LEAD WAS REPLACED. THE PATIENT WAS GOOD AFTER THE EVENT AND THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632244 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | V-341, UNK080714 |