FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1955271
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00154
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 24, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 VENTRICULAR OVERSENSING WAS OBSERVED. THE PATIENT WAS SYMPTOMATIC DURING THE OVERSENSING, BUT DID NOT BECOME SYNCOPAL. ISOMETRICS, POSITIONAL MOVEMENTS AND POCKET MANIPULATION SHOWED NO NOISE. THE LEAD WAS EXPLANTED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |