FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073035
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02285
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 21, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A LEAD TIP STIFFNESS TEST WAS FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER¿S DOWN ARROW BUTTON IS BROKEN/CRACKED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Description of Event or Problem · 1
THREE DAYS POST-IMPLANT, IT WAS REPORTED THAT THE LEAD HAD PERFORATED THE HEART. AS SUCH, THE LEAD WAS EXPLANTED. THE CONDITION OF THE PATIENT WAS UNKNOWN BEFORE AND AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7022/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |