FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM PASSIVE FIXATION
MDR report key: 1050767
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01719
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 18, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ANALYSIS CONFIRMED THE UNANTICIPATED THERAPY DELIVERY IN THE LABORATORY. THE REPORTED PROBLEM WAS DUE TO A FRACTURED SENSING COIL CLOSE TO THE CRIMP SLEEVE TO THE CONNECTOR RING . THIS WAS A RESULT OF FATIGUE AND THE CAUSE OF THE INTERMITTENT OPEN CIRCUIT.
Description of Event or Problem · 1
PATIENT RECEIVED LARGE AMOUNT OF INAPPROPRIATE THERAPIES. AS SUCH, THE LEAD WAS EXPLANTED.
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A LINE THROUGH DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7070/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |