FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220238
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04151
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- September 21, 2012
- 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
- OH
- 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 A SYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH SYSTEMIC INFECTION. TEE REVEALED VEGETATIONS ATTACHED TO THE LEAD. PRIOR TO PRESENTATION, THE LEAD PACE/ SENSE PORTION WAS REPLACED DUE TO POOR SENSING AND CAPTURE THRESHOLD. BOTH NORMALLY FUNCTIONING LEADS WERE EXPLANTED. NO FURTHER INFORMATION CAN BE OBTAINED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320057 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |