FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2993621
·
Received March 7, 2013
Report
- Report Number
- 2938836-2013-00618
- Event Type
- Death
- Date Received
- March 7, 2013
- 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 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 INAPPROPRIATE THERAPY DUE TO NOISE WAS OBSERVED. INSULATION DAMAGE WAS SUSPECTED. DURING EXPLANT, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PROCEDURE WAS STOPPED. A THORACOTOMY WAS PERFORMED TO REPAIR A TEAR OF THE SUBCLAVIAN VEIN. THE PATIENT LOST A LARGE AMOUNT OF BLOOD AND EXPIRED AFTER RESCUE EFFORTS FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97097 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death |