ELLIPSE VR, DF-4 CONNECTOR

Report

Report Number: 2938836-2014-13484
Event Type: Injury
Date Received: July 18, 2014
Date of Event: July 1, 2014
Manufacturer: ST. JUDE MEDICAL, INC., CRMD
Product Code: LWS
PMA / PMN Number: P910023
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Additional Manufacturer Narrative · 1

THE REPORTED FIELD EVENT OF LONG CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN ANOMALOUS HV CAPACITOR WAS FOUND. THE CAUSE OF THE LONG CHARGE TIME WAS AN ANOMALOUS HV CAPACITOR.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED BY A COMPETITIVE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A NOTIFIER ALERT WAS DELIVERED INDICATING THAT THE DEVICE HAVE REACHED MAXIMUM CHARGE TIME. TIME OUT MESSAGE WAS CLEARED UPON PERFORMING FIRST CAPACITOR REFORM. A SECOND REFORM WAS DONE AND THE DEVICE PRODUCED A POPPING SOUND AND TIMED OUT AGAIN. DEVICE WAS SCHEDULED FOR REPLACEMENT, HOWEVER DUE TO INSURANCE REASONS, THE PATIENT COULD NOT HAVE THE PROCEDURE PERFORMED WHERE HIS PHYSICIAN PRACTICES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421721	ELLIPSE VR, DF-4 CONNECTOR	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	ST. JUDE MEDICAL, INC., CRMD	CD1311-36Q	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Required Intervention