BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE VE POWER BASE UNIT

    MDR report key: 2971224 · Received September 13, 2007

    Report

    Report Number
    2916596-2007-00146
    Event Type
    Injury
    Date Received
    September 13, 2007
    Date of Event
    September 13, 2007
    Report Date
    September 13, 2007
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SVC EVALUATION OF THE PBU REVEALED THAT THE INTERNAL BATTERY WAS DISCONNECTED, BUT DID NOT CONFIRM ANY PUMP STOPPAGE. THE BATTERY WAS RECONNECTED AND FUNCTIONAL TESTING ON THE PBU WAS PERFORMED WITH THE UNIT PASSING ALL TESTS. THE MFR COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE INTERNAL BATTERY BEING DISCONNECTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE MFR IS CLOSING ITS FILE ON THIS CASE.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY HOSPITAL STAFF THAT AFTER A POWER FAILURE THE POWER BASE UNIT'S (PBU) INTERNAL BACK UP BATTERY DID NOT START RESULTING IN LOSS OF POWER TO THE LVAD. AS A RESULT, THIS POWER FAILURE COULD HAVE RESULTED IN A POSSIBLE PUMP STOPPAGE. THE HOSP PROVIDED THE PT WITH A BACK-UP PBU WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE VE POWER BASE UNIT LVAD POWER BASE UNIT DSQ THORATEC CORP. 1240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention