FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073613
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02497
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS BRADED AT 7.2 CM FROM THE CONNECTOR PIN AND THE SENSING "COIL WAS EXPOSED DUE TO FRICTION TO THE ICD CAN. THE DAMAGE COULD CAUSE THE NOISE THAT WAS REPORTED IN THE FIELD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE. THE NOISE WAS REPRODUCED WITH PATIENT MOVEMENT. LOW LEAD IMPEDANCE WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |