FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3210480
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03225
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 22, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING APPROPRIATE SHOCK THERAPY FOR VT. IT WAS NOTED THAT THE DEVICE DELIVERED SHOCK WHICH FAILED TO CONVERT THE PATIENT. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA IMAGING. DFT TESTING WAS SUCCESSFUL. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310528 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |