FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2486913
·
Received March 10, 2012
Report
- Report Number
- 2017865-2012-01680
- Event Type
- Death
- Date Received
- March 10, 2012
- Date of Event
- January 20, 2012
- 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
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ISCHEMIC HEART DISEASE AS THE CAUSE OF DEATH.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT DEVICE CHANGE-OUT, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING AN ALERT FOR OUT OF RANGE HV IMPEDANCE. DURING LEAD EXTRACTION, THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. NO SIGNS OF SVC TEAR OR PERFORATION WERE SEEN. A TEMPORARY PACING WIRE WAS INSERTED BUT BP CONTINUED TO DROP. THE PATIENT LATER EXPIRED. THE PHYSICIAN SUSPECTED PULSELESS ELECTRICAL ACTIVITY DUE TO DECREASED HEART MUSCLE PERFUSION SECONDARY TO SEVERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death |