FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073032
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02282
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 15, 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 Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED A HIGH CAPTURE THRESHOLD AND THE SENSING THRESHOLD VARIED. AT IMPLANT, THE CAPTURE AND SENSING THRESHOLDS WERE NORMAL. DURING A REPOSITION ATTEMPT, THE HELIX WOULD NOT COMPLETELY RETRACT AND ADVANCE. THEREFORE, THE LEAD WAS EXPLANTED. THE PATIENT WAS ASYMPTOMATIC AND REPORTED NO COMPLICATIONS.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OPERATOR CUT HER FINGER WHILE CHANGING THE CAP PIERCER BLADE. PART OF THE WICK CAUGHT ON THE BLADE AND SHE TRIED TO REMOVE THE WICK FROM THE BLADE AND CUT HER FINGER. THE OPERATOR WAS TAKEN TO THE ER. NO OTHER DETAILS WERE SUPPLIED.
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 | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |