FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 3220204
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04274
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 24, 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
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR INAPPROPRIATE SHOCKS DUE TO NOISE. NORMAL ELECTRICAL MEASUREMENTS WERE OBSERVED. THE PHYSICIAN DECIDED THAT BASED ON PATIENT GENERAL CLINICAL CONDITION, TO TURN THE HV THERAPIES OFF AND PROGRAM THE ICD IN BRADY MODE. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321317 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |