FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1830911
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03242
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 29, 2010
- 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THE OUTER COIL WAS SQUEEZED AND DAMAGED THE INNER INSULATION DUE TO A SHORT CIRCUIT BETWEEN THE OUTER AND INNER COIL. THIS DAMAGE WOULD CAUSE NOISE AND DELIVER INAPPROPRIATE THERAPIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING INAPPROPRIATE SHOCKS. EGMS INDICATED A LEAD ANOMALY. THE LEAD WAS REPLACED.
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A LINE THROUGH THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT METER WAS SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |