BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1172073 · Received September 23, 2008

    Report

    Report Number
    2916596-2008-00133
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REMAINS ONGOING WITH THE LVAD. THE EXPLANTED DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE RESEARCH COORDINATOR THAT WHEN THE PATIENT LIFTED A GAS CAN HE "FELT SOMETHING PULL" IN HIS ABDOMEN AROUND THE PUMP AND DRIVELINE. THAT AREA HAD PULLED OPEN, AND SOME BLEEDING OCCURRED. TWO DAYS LATER, THE PATIENT CALLED THE HOSPITAL TO REPORT THE EVENT AND WAS INSTRUCTED TO GO INTO THE CLINIC. THE PATIENT HAD CULTURES TAKEN AND AN INFECTION WAS FOUND. THE PATIENT WAS ADMITTED AND TREATED FOR THE INFECTION AND DEBRIDEMENT OF THE PUMP POCKET. A COUPLE OF WEEKS LATER, AFTER NEGATIVE CULTURES WERE OBTAINED, THE PATIENT WAS DISCHARGED. ANTIBIOTICS WERE CONTINUED ALONG WITH CHANGE OF DRESSINGS FOR THE WOUND, AND THE PATIENT WAS MONITORED. APPROXIMATELY 4 MONTHS LATER, THE PATIENT REPORTED INCREASING DRAINAGE FROM HIS WOUND AND THAT THE PUMP WAS EASILY VISIBLE. THE RESEARCH COORDINATOR REPORTED THAT ALTHOUGH THE PATIENT WAS NOT HARMED BY THE REPORTED EVENT, THE POTENTIAL FOR SEPSIS REMAINED, AND AS A RESULT, A DECISION WAS MADE TO EXCHANGE THE PUMP, AND THE PATIENT'S LVAD WAS REPLACED WITH ANOTHER LVAD. THE PATIENT REMAINS ONGOING WITH THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention