FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242685
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06174
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 3, 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
THE PATIENT WAS BROUGHT INTO THE CATH LAB FOR DFT TESTING DUE TO T-WAVE OVERSENSING. DURING TESTING, IT WAS NOTICED THAT THERE WAS A LARGE AMOUNT OF CONTINUAL NOISE ON THE RV PACE/SENSE LEAD AND VARYING HIGH IMPEDANCE MEASUREMENTS. LEAD FRACTURE SUSPECTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED (B)(6), 2011.
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 | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |