FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1050962
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01901
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- December 11, 2007
- 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
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A LEAD TIP STIFFNESS TEST WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE VENTILATOR WAS RETURNED TO THE FACTORY FOR EVALUATION. REVIEW OF THE VENTILATOR EVENT LOG CONFIRMED A VENT INOP DUE TO A PRESSURE SENSOR FAILURE DURING OPERATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIAPHRAGMATIC TWITCHING AND HIGH THRESHOLDS. THE LEAD WAS EXPLANTED DUE TO A POSSIBLE PERFORATION THROUGH THE RV APEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |