FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3080063
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00932
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- February 21, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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
THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC AFTER RECEIVING A PATIENT NOTIFIER. UPON REVIEW, LOW HV LEAD IMPEDANCE IN THREE VECTORS WAS NOTED. FURTHER INVESTIGATION REVEALED THAT THE DEVICE INAPPROPRIATELY DELIVERED. THE PATIENT NOTIFIER DUE TO POSTPONED MEASUREMENT. SUBSEQUENT FOLLOW-UP, NOTED ALL ELECTRICAL PARAMETERS NORMAL AFTER PERFORMING PROGRAMMER COMMANDER SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182899 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1590/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |