BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4223739 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01999
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    July 21, 2014
    Report Date
    October 2, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MFR FOR EVALUATION, AS IT WAS NOT EXPLANTED. A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED TO THE MFR THROUGH THE DEVICE TRACKING FORM FROM THE HOSP THAT THE PT EXPIRED ON (B)(6) 2014. THE CAUSE OF EXPIRATION WAS NOTED AS "RESPIRATORY FAILURE." ADDITIONAL INFO WAS RECEIVED FROM THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSP ON (B)(6) 2014 FOR A GI BLEED AND WAS GIVEN A TRANSFUSION OF 20 UNITS OF PACKED RED BLOOD CELLS. AN UPPER GI ENDOSCOPY, COLONOSCOPY, AND SMALL BOWEL ENTEROSCOPY (TWICE) WERE PERFORMED. TWO AREAS WITHIN THE JEJUNUM WERE EMOBILIZED AND CLIPPED. THE PT WAS TRANSFERRED TO A REHABILITATION CTR ON (B)(6) 2014. THE PT WAS FOUND UNCONSCIOUS BY HIS WIFE AND WAS ADMITTED INTO THE HOSP. THE PT WAS NOTED TO HAVE PLEURAL EFFUSION. ON (B)(6) 2014, THE PT EXPERIENCED BLURRED VISION WHICH RESOLVED ON ITS OWN. ON (B)(6) 2014, THE PT WAS DISCHARGED TO A REHABILITATION CTR. ON (B)(6) 2014, THE PT WAS READMITTED INTO THE HOSP FOR LOW HGB (6.6) AND WAS GIVEN A BLOOD TRANSFUSION. ON (B)(6) 2014, THE PT UNDERWENT A SMALL ENTEROSCOPY, AND THE SOURCE OF THE BLEED WAS NOT FOUND. THE PT'S PULMONARY STATUS DECLINED. THE PT WAS MADE DNR AND LATER EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698100 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 128597

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention