BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    MDR report key: 3915428 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00867
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CABLE WOULD NOT BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. LOG FILES SENT IN FROM THE VAD COORDINATOR SHOWED MULTIPLE PUMP STOPPAGES WITH NO ERRATIC SPEEDS OR DROPS. REPLACING THE PATIENT CABLE WAS RECOMMENDED, AND THE CABLE WAS REPLACED. IT WAS CONFIRMED THAT THE CABLE WOULD NOT BE RETURNING FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328834 HEARTMATE 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE DSQ THORATEC CORPORATION 103426 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention