BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE POWER MODULE PATIENT CABLE (14 VOLT)

    MDR report key: 3001313 · Received March 8, 2013

    Report

    Report Number
    2916596-2013-00248
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS DISCHARGED HOME APPROXIMATELY 48 HOURS FOLLOWING HIS ADMISSION. THE PATIENT REMAINS ON LVAD SUPPORT WITH THIS PUMP AND IS REPORTED TO BE DOING WELL. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE CABLE FOR ANALYSIS. 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. APPROXIMATELY 16 MONTHS POST-IMPLANT, THE SURGEON REPORTED THAT THE PATIENT FAINTED WHILE AT HOME, SWITCHING FROM BATTERY TO POWER MODULE SUPPORT. THE PATIENT'S WIFE RECONNECTED THE PATIENT TO BOTH BATTERIES AND THE PUMP RESTARTED. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR EVALUATION AND WAS FOUND TO BE DOING FINE. UPON INSPECTION OF THE PATIENT'S EQUIPMENT, THE SURGEON OBSERVED A BENT PIN ON THE POWER MODULE PATIENT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99424 HEARTMATE POWER MODULE PATIENT CABLE (14 VOLT) DSQ: POWER MODULE PATIENT CABLE DSQ THORATEC CORP. 103426 34756240210

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention