FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION LEAD
MDR report key: 1073510
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02404
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 7, 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
THE REPORTED NOISE COULD NOT BE CONFIRMED IN THE LABORATORY DUE TO A PARTIAL LEAD RETURN. INSULATION OF THE RETURNED PORTION WAS CUT AT 4.3 CM FROM THE CONNECTOR PIN. COIL CABLES AND INSULATIONS WERE CUT AT 12.1 CM FROM THE CONNECTOR PIN. THE DAMAGE FOUND IS CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT. THE RETURNED LEAD PORTION EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE EVALUATION CANNOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE ON THE LEAD. LOW IMPEDANCE AND HIGH CAPTURE THRESHOLD WERE ALSO NOTED. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |