FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAS, EUROPE

MDR report key: 2780773 · Received October 5, 2012

Report

Report Number: 2916596-2012-00939
Event Type: Injury
Date Received: October 5, 2012
Date of Event: September 9, 2012
Report Date: September 9, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. ACCORDING TO THE INFORMATION RECEIVED, THE EXPLANTED PUMP IS NOT AVAILABLE FOR EVALUATION AND WILL NOT BE RETURNED TO THE MANUFACTURER. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

Description of Event or Problem · 1

THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 1.5 YEARS POST-IMPLANT, THE PATIENT REPORTED RED HEART ALARMS TO THE VAD COORDINATOR AND WAS ASKED TO RETURN TO THE HOSPITAL FOR READMISSION TO CHECK THE ALARM HISTORY. THE DATA REVEALED DECREASES IN SPEED WHILE THE PATIENT WAS SUPPORTED BY BATTERIES AS WELL AS BY THE POWER MODULE. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE DECREASES IN SPEED CONTINUED. X-RAYS OF THE INTRACORPOREAL PORTION OF THE PERCUTANEOUS LEAD REVEALED NO DAMAGE. THE PATIENT SHOWED NO SIGNS OF HEMOLYSIS, BUT THROMBUS IS SUSPECTED. ADDITIONAL INFORMATION WAS PROVIDED APPROXIMATELY TWO WEEKS LATER INDICATING THAT A DECISION WAS MADE TO EXCHANGE THE PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEARTMATE II LVAS, EUROPE	DSQ: LEFT VENTRICULAR ASSIST DEVICE	DSQ	THORATEC CORP.	103693	100019

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention