FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050952
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01891
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 13, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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
DURING FOLLOW-UP, THE ELECTROGRAMS SHOWED THAT SEVERAL SHOCKS HAVE BEEN DELIVERED DUE TO VENTRICULAR NOISE. FEW DAYS LATER, THE ELECTRICAL VALUES AT INTERROGATION WERE NORMAL, NO NOISE COULD BE REPRODUCED AND NO EVIDENCE OF A LEAD DAMAGE WAS OBSERVED. THE LEAD WAS REPLACED AND CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |