ELLIPSE DR, DF4 CONNECTOR

Report

Report Number: 2938836-2013-01974
Event Type: Injury
Date Received: May 9, 2013
Date of Event: February 25, 2013
Manufacturer: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code: LWS
PMA / PMN Number: P910023
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED FIELD EVENT OF EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY. THE HIGH VOLTAGE CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER ANALYSIS. THE CAUSE OF THE EXTENDED CHARGE TIME WAS AN ANOMALOUS CAPACITOR.

Additional Manufacturer Narrative · 1

ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING IMPLANT THE CHARGE TIME WAS 11.1 SECONDS WHICH WAS HIGHER THAN 7.8 SECONDS BEFORE IMPLANT. THE PHYSICIAN WAS CONCERNED. DFT TESTING WAS REPEATED. THE CHARGE TIME WAS 3.9 SECONDS. THE DEVICE REMAINED IMPLANTED.

Description of Event or Problem · 1

NEW INFORMATION NOTED THAT THE PATIENT PRESENTED IN ER AFTER RECEIVING AN ALERT. DEVICE INTERROGATION REVEALED TIME OUT ON CAPACITOR MAINTENANCE. CAPACITOR MAINTENANCE WAS MANUALLY PERFORMED AND AN AUDIBLE POP WAS HEARD FROM THE DEVICE. THE DECISION WAS MADE TO EXPLANT THE DEVICE. PATIENT WAS IN STABLE CONDITION THROUGHOUT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
202995	ELLIPSE DR, DF4 CONNECTOR	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION	CD2311-36Q	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention