FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2973331
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00155
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- December 5, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL FOR A NORMAL FOLLOW UP. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WILL BE EXPLANTED WHEN THE DEVICE REACHES ERI.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT NOISE AND A DECREASE IN SENSING WERE OBSERVED VIA REMOTE TRANSMISSION. PATIENT WILL BE BROUGHT IN FOR FURTHER ASSESSMENT, AND LEAD REVISION IS PROBABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75897 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |