BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3960054 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01069
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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. THE VAD COORDINATOR REPORTED THAT THE PT WAS FOUND TO HAVE AN INTRACEREBRAL HEMORRHAGE AT AN OUTSIDE HOSP AFTER HIS WIFE CALLED 911 ON THE ADVICE OF THE LVAD TEAM. THE PT'S WIFE CALLED TO REPORT THE PT WAS "DELIRIOUS, PULLING AT WIRES AND WAS VOMITING OVERNIGHT." ANTICOAGULATION WAS REVERSED, THE PT MONITORED BY NEUROLOGY AND NEUROSURGERY. VAD INTERROGATION REVEALED THE DRIVELINE HAD BEEN DISCONNECTED A COUPLE TIMES FOR A BRIEF PERIOD ON ADMISSION TO THE HOSP. NO SURGERY WAS INDICATED. THE PT UNDERWENT A CT AND CTA. FURTHER INFO FROM THE VAD COORDINATOR INDICATED THE PT WAS NOT FOUND TO HAVE AN EMBOLIC STROKE AND WAS DISCHARGED HOME ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417581 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120646

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention