FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2242775
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06020
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- July 22, 2011
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. NOISE WAS REPRODUCIBLE WITH ISOMETRICS. LOW IMPEDANCE WITH AN INCREASE IN CAPTURE WERE FOUND. LEAD FRACTURE SUSPECTED. AT DEVICE CHANGE OUT FOR ERI. LEAD WAS CUT, CAPPED, AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |