FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1954928
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00199
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 26, 2010
- 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 DURING A FOLLOWUP VISIT, THE R-WAVES HAD DECREASED. AN INDUCTION TEST WAS PERFORMED AND THE DEVICE DID NOT RESCUE THE PATIENT. EXTERNAL DEFIBRILLATION WAS PERFORMED TO END THE VF EPISODE. THE PHYSICIAN OPTED TO CONNECT THE LV AND RV LEAD IN EACH OTHER'S PORT, SINCE THE RV SENSE/PACE LEAD COULD NOT BE REPLACED. THE PATIENT'S LEFT SUBCLAVIAN VEIN SEEMED TO BE CLOSED. INDUCTION TESTING WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |