FDA Adverse Event Malfunction Summary report: N

RIATA ACTIVE FIXATION

MDR report key: 2950154 · Received February 8, 2013

Report

Report Number: 2938836-2013-00010
Event Type: Malfunction
Date Received: February 8, 2013
Date of Event: December 10, 2012
Manufacturer: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code: NVY
PMA / PMN Number: P950022
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AN EXTERNAL INSULATION ABRASION WAS FOUND AT 24.8-25.4CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. AN INTERNAL INSULATION ABRASION WAS FOUND AT THE SAME LOCATION. ONE OF THE SVC CONDUCTORS WAS MELTED AT THIS LOCATION. THIS IS CONSISTENT WITH THE FIELD EVENT OF LOW SHOCK IMPEDANCE AND INSULATION ANOMALY. AN INTERNAL ABRASION WAS FOUND AT 26.9-27.6CM FROM THE CONNECTOR PIN. THE ETFE COATING WAS INTACT AT THIS LOCATION.

Additional Manufacturer Narrative · 1

ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ERI DEVICE CHANGE OUT. A POSSIBLE OUTPUT CIRCUIT DAMAGE MESSAGE AFTER DFT TESTING WAS NOTED. THE ALERT WAS CLEARED AND THE PATIENT WAS RE-INDUCED. A LOUD POP WAS HEARD AND THE DEVICE FAILED TO RESCUE THE PATIENT, THE ARRHYTHMIA BROKE SPONTANEOUSLY. LOW SHOCK IMPEDANCE AND AN INSULATION ANOMALY WAS NOTED. THE DEVICE AND LEAD WERE REPLACED WITHOUT COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54906	RIATA ACTIVE FIXATION	DEFIBRILLATION LEAD	NVY	ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION	1580/65	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR			(B)(4)