RIATA ACTIVE FIXATION LEAD

Report

• Report Number: 2017865-2008-02355
• Event Type: Malfunction
• Date Received: July 11, 2008
• Date of Event: May 6, 2008
• Manufacturer: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
• Product Code: LWS
• PMA / PMN Number: PMA00001
• Removal / Correction Number: NA
• 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 4-RELIABILITY LABORATORY TECHNICIAN NOT APPLICABLE -ST. JUDE MEDICAL RELIABILITY LABORATORY NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS OBSERVED INSULATION ABRASION CAUSED BY FRICTION TO ANOTHER DEVICE. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.

Description of Event or Problem · 1

THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

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

Terms

Patient problem · 1

• No Patient involvement

Product problems · 1

• Malfunction

Source type · 1

• Other

Type of report · 1

• Initial submission