BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4190132 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01668
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOW SPEED AND PUMP STOPPAGE EVENTS WERE CONFIRMED VIA THE PATIENT¿S SYSTEM CONTROLLER EVENT HISTORY THAT WAS SUBMITTED; HOWEVER, THE CAUSE OF THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED AS THE DEVICE REMAINS IN USE AND NOT AVAILABLE FOR EVALUATION. THE EVENT HISTORY INDICATED MULTIPLE LOW SPEED AND PUMP STOPPAGE EVENTS WITH CORRESPONDING ELEVATIONS IN PUMP POWER. THE CAPTURED VOLTAGE VALUES DURING THE EVENTS APPEARED TO INDICATE THAT THE SYSTEM WAS OPERATING ON THE POWER MODULE AT THE TIME OF THE EVENTS. BASED ON THE MANUFACTURER¿S PREVIOUS COMPLAINT EXPERIENCE, THE CAPTURED EVENTS APPEAR CONSISTENT WITH A POTENTIAL DRIVELINE ISSUE. EXAMINATION OF THE X-RAYS THAT WERE SUBMITTED INDICATE TWO AREAS OF POTENTIAL BRAIDED SHIELD BREAKDOWN TO THE INTERNAL PORTION OF THE DRIVELINE; HOWEVER, WIRE DAMAGE COULD NOT BE CONFIRMED FROM THE X-RAY. THE PATIENT WAS PROVIDED WITH AN UNGROUNDED PATIENT CABLE AND REMAINS STABLE AT HOME. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 15 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PT EXPERIENCED PUMP STOPPAGES WHILE CONNECTED TO A POWER MODULE. THE PT LATER WENT TO THE CLINIC AND IS STABLE ON BATTERY SUPPORT. X-RAYS WERE TAKEN AND SHOWED POTENTIAL INTERNAL DRIVELINE DAMAGE. THE CLINIC REQUESTED A NON-GROUNDED PT CABLE. IT WAS ALSO REPORTED THAT IN (B)(6) 2013, THE PT HAD FORGOTTEN THAT HIS SYS CONTROLLER WAS IN BED AND WITH A STRONG FORCE PULLED ON HIS DRIVELINE. AS A RESULT THE PT EXPERIENCED PUMP STOPPAGES AND REDUCTIONS IN SPEED. THE PT'S SPOUSE REPORTED THAT THE "DRIVELINE MOVED A LITTLE BIT OUT OF THE BODY DURING THE LAST MONTHS."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS STABLE AT HOME WITH THE NON-GROUNDED CABLE AND WAS NOT IN A POSITION FOR A PUMP EXCHANGE OR TRANSPLANT. THIS DECISION WAS MADE BY THE HOSPITAL. NO FURTHER ISSUES WERE OBSERVED AFTER PLACING THE PATIENT ON THE UNGROUNDED PATIENT CABLE. DUE TO THE PATIENT'S STROKE THAT ENDED IN A MOTOR APHASIA, BOTH THE SURGEON AND PATIENT INCLUDING THEIR RELATIVES REFUSED A FURTHER OPERATIVE PROCEDURE. THE PATIENT REPORTEDLY RECOVERED FROM THE STROKE. THE PATIENT WAS ALSO ABLE TO WALK AND IS ACTIVE AGAIN. THE ONLY ISSUE THAT REMAINED IS A MOTOR APHASIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578054 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 126159

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other