FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4863570
·
Received June 23, 2015
Report
- Report Number
- 2938836-2015-27370
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- April 22, 2015
- Report Date
- April 22, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE DETECTED UNDER FLUOROSCOPY. AN ASYMPTOMATIC PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD WILL BE CAPPED AND REPLACED DURING NORMAL ICD CHANGE-OUT.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT PRESENTED WITH SYNCOPE AND WORE A LIFE VEST. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405692 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1581/65 | 0002666485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |