FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050850
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01797
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 INHIBITION OF PACING WAS OBSERVED. THE PATIENT FELT SYMPTOMATIC AND REPORTED FEELING DIZZY AND LIGHT-HEADED. TECHNICAL SERVICES NOTED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS AND SOME POSSIBLE OVERSENSING ON THE ATRIAL CHANNEL. A HIGH VOLTAGE LEAD INTEGRITY CHECK WAS PERFORMED AND MEASUREMENTS WERE HIGH. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED, AND DEFIB REMAINS ACTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |